OnCore Training Manual
V13.5 Reference Guide
Questions?
OnCoreSupport@ucdenver.edu
This manual has been adapted for this institution based on materials provided by Forte Research Systems. For further detailed information refer to
the website: www.ucdenver.edu/research/ResearchAreas/OnCore. Additional information can be found at www.Onsemble.net.
OnCore Navigation
What is OnCore?
OnCore stands for Online Collaborative Research Environment. It is a Clinical Trial Management
System developed by Forte Research Systems, Inc. and is designed to assist the University of
Colorado in managing its robust portfolio of research trials.
OnCore requires users to navigate the application appropriately to be able to fully utilize the
application’s functions. End users may refer to the keyboarding short-cuts to familiarize themselves
with quick ways to move through the OnCore application placed at the end of this section.
Home Page/Screen Layout
The first time a user log’s into OnCore, the Home Page will look something like this. The User’s
Name will appear at the top of the Home Page Screen. If this Name is not correct, please
immediately notify the OnCore Support Team at OnCoreSupport@ucdenver.edu.
Additionally the OnCore Home Page will display the following:
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End User’s Default User Role
Link to the OnCore Home Page
OnCore Home Page Configuration Wheel
Link to My Profile Settings
Link to Various Help Information (not configured at this time). If help is needed,
contact OnCoreSupport@ucdenver.edu.
Navigation │ 1 of 10
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Log Off Button
Navigation Menu
Roles/Security
Each OnCore User is assigned to at least one User Role. OnCore utilizes User Roles to distribute
various system privileges, as each area and function within OnCore has privilege requirements.
Each user is assigned the User Role(s) necessary for their job function.
When Users log into OnCore, the default role will display for that User. However, the User may
change the User Role without logging off by selecting the arrow to the right of the displayed User
Role at the top of the screen. The User may also change their Role by selecting My Profile at the
top right of the screen and select a new role there.
My Profile
The My Profile Button allows an End User to modify their display preferences within OnCore, as
well as revise their default User Role, should the User have more than one Role.
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Default User Role – Users may change the Default User Role by selecting from the drop down
list provided and Clicking “Submit”.
Theme – The OnCore “color theme” may be changed for each individual user if so desired by
selecting the desired theme from the drop down list provided and Clicking “Submit”.
Change Password – DO NOT USE – Users will never be asked to Change their OnCore
Password, as the University of Colorado utilizes Users’ Active Directory to access OnCore.
Navigation │ 2 of 10
OnCore utilizes various Menus and Tabs to navigate
throughout the application. The main Horizontal Drop
Down Menu is at the top of every screen. By clicking
on a selected area of the application, additional options
will appear in drop-down format. Keep in mind, the
options for each user is dependent upon the security
and privileges within the User Role being used.
OnCore also uses Vertical Menus once within a section of the application, as well as Horizontal
Tabs that will categorize information within the Menu Option.
Navigation │ 3 of 10
Navigation Tips & Data Entry Tools
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Only One OnCore Session – Only one session (Internet Browser Window) of OnCore should
ever be open at one time. Multiple sessions of OnCore will result in misbehavior, could result in
data loss, and can only be resolved by closing the additional sessions.
Do Not Use Pop-Up Blockers – There are times that OnCore will use Pop-Up Dialogue Boxes
for data entry/selection. Pop-Up Blockers will prevent these windows from displaying; therefore,
Users must ensure their Internet Browser Pop-Up Blocker is disabled.
Avoid the Browser Back Button – Avoid using the Browser Back Button while working within
OnCore. Instead use the navigation buttons, tabs, menus within the OnCore Application to
navigate. Using the Browser Toolbar is outside the OnCore application and may lead to
unexpected results and unsaved data.
CTRL+F = FIND – Utilizing the CTRL Key with the F Key provides a quick search within a list.
Select the List, document or screen desired to be searched, then hold down the CTRL Key while
also pressing the F Key.
F11 – F11 will display the Full Browser Screen and hide taskbars. Pressing F11 again will return
the screen to the original setting.
Logging Off – To properly exit OnCore, Users must select the Log Off Menu Link at the top right
of the screen.
Resetting Password – Users cannot reset their password in OnCore alone. Users must reset
their UCD Password by calling the OIT Help Desk at 303-724-4357 or by following OIT
instructions found on the website: https://passport.ucdenver.edu/oim. User will log in with UCD
Active Directory.
Hyperlinks – Throughout OnCore, Users are presented information with a BLUE link. This will
allow the user to short cut to other areas of the system without utilizing a Menu.
Find-as-you-type Field – At the upper left of the screen is a data entry field used to select
protocols.
Date Fields and Interactive Calendars
Throughout the application OnCore provides users the ability to short hand dates (called a date
widget) for more efficient date entry. Entering the date in any of the formats following, then
tabbing/clicking off the field will default the appropriate date in the MM/DD/YYYY format. Commonly
used date widgets are listed below:
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Short Cut Entry
t
t+/-#
Result
Today’s Date
Today’s Date plus or minus the number of days
entered
t+1
Tomorrow
t-1
Yesterday
w+/-#
Today’s Date plus or minus the number of
weeks entered
w+1
1 Week from Today
w-1
1 Week Ago from Today
m+/-#
Today’s Date +/- the number of months
entered
m+1
1 Month from Today
m-1
1 Month Ago from Today
y+/-#
Today’s Date +/- the number of years entered
y+1
1 Year from Today
y-1
1 Year ago from Today
mb
Month Beginning – may be alone or with +/- #
of months
me
Month End – may be alone or with +/- # of
months
yb
Year Beginning – may be alone or with +/- # of
months
ye
Year Ending – may be alone or with +/- # of
months
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Numbered Dates – Single Digit months and days may be entered if slashes are used:
M/D/YY, MM/DD/YYY. No dashes are required, but double digit months and days are
required MMDDYY, MMDDYYY.
Dates Auto Format – Dates may also be entered allowing the system to format the date for
the user.
Interactive Calendars – Selecting Interactive Calendar Grids will provide the user
with an Interactive Calendar where they may select the date by clicking directly
on the Calendar. The arrows on the Calendar will allow the user to move from
month to month, year to year, and select the exact date desired.
Information Tables
Throughout the application, there are some screens that present the information in Table format.
OnCore provides a number of ways to Sort and Display that information on the Screen, as well as
export the information to other formats.
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Page Size – Here the system allows the user to choose how many rows of information will
display per page. 10, 20, 50, 100 are the typical choices, and many screens will allow the
user to Save their Preferences for that page.
Filter – The User may type key words from the information shown on the screen to filter out
what data is displayed.
Page Navigation Buttons – These buttons allow the user to navigate forward and backward,
Start to End, of pages of information if desired.
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Column Sorts – Left Clicking at the top of a column allows the user to sort Ascending or
Descending (second click; same column) to sort data by that parameter. A right click on the
same column allows the end-user to select a secondary sort parameter as well.
Selecting Protocols
The majority of trials have a naming convention. The Protocol Number is typically numeric
characters. Users may enter numbers from the Protocol Number in the “Select Protocol” field to
select the appropriate study.
As data is entered into the Select Protocol Field, the result list is narrowed. Selecting Enter will
display the highlighted study, or the user may utilize the arrow keys or mouse to select from the list.
Users may also select Protocols by entering the following identifying numbers/information into the
Select Protocol Field
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IRB Number
PRMS Number
Sponsor Protocol Number
Grant Number
Once a Protocol is selected, the OnCore Screen Header will populate, and will remain the same as
the user navigates within functions in the application.
The Header provides “Read Only” summary information for the Protocol and is consistent across
the group of related pages that are associated with the bar.
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Widgets
A Widget is a personalized display of OnCore data. This data is comprised of hyperlinks allowing
the End User to quickly access the related information instead of being required to access various
menu selections.
Currently OnCore provides the following Widgets users may add to their OnCore Home Page.
For End Users to create their personal Widgets, Access the Home
Page Configuration Gear Wheel located in the top right hand
corner of the OnCore Home Page.
The Home Screen
Configuration Screen will display.
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End Users may Click the Add Checkbox to the right of the Widget desired. Once all are selected,
Click Save, and the Widgets will appear in the appropriate columns. Widgets are deleted from this
screen also.
Once all Widgets are placed as desired, Select the Home Page Button at the top right of the Screen
to access the OnCore Home Page Screen.
The following Widgets require further configuration before loading:
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Protocol Widget
SAE’s Widget
Subjects Widget
Protocol/ SAE’s/ Subjects Widget Configuration Settings
Located at the top of the Protocol, SAE’s and Subjects Widgets are 3 control buttons. These buttons
allow configuration of the Widget, Deletion of the Widget, and an Expanded View of the information
within the Widget.
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Selecting the Widget Configuration Button will allow the End-User to further select how Protocols,
SAE’s and Subjects will be displayed within the Widget.
The individual Widget configuration all 3 work on the same primary settings available. End Users
may select for Protocols, SAE’s, or Subjects to appear if they are bookmarked. To bookmark a
Protocol or a Subject, when the PC Console or the Protocol or the Subject Console of the Subject
is accessed, click on the White Star in the top left hand of the screen, it will turn gold, and will then
be bookmarked.
Additionally the configuration settings may allow the End-User to also display information within that
widget based on the End-User’s Role as placed on PC Console>Details>Staff and/or Subject
Console>On Study> Subject Staff.
Also, End-Users may customize what fields display, the maximum number of items permitted to list
within the widget, as well as removing current bookmarks from Protocols and Subjects that are
bookmarked without needing to access them individually.
Navigation │ 10 of 10
PC Console – Protocol Creation and Set Up
The PC (Protocol Coordinator) Console is the central repository for protocol details. Here is where
you enter and view data related to a study. Protocol data includes the protocol definition,
management and treatment staff, sponsor, participating institutions, regulatory information,
investigational drug and device information, and the protocol’s calendar (visit schedule and what is
done during visits).
Each protocol is identified by a unique alphanumeric protocol number.
Creating a Protocol
1. Navigate to the PC Console via the Protocols  PC Console menu item.
The PC Console is used to create, view, and modify protocols and protocol information. Its
display is divided into vertical and horizontal tabs to organize the broad scope of protocol data.
Above the vertical tabs is the Select Protocol field, a find-as-you-type field used to locate
existing Protocols. Protocols can be located by their protocol number or other protocol
identifiers: IRB No, Pharmacy No, PRMS No, Sponsor No, CTRC.
2. Select the New Protocol vertical tab.
The New Protocol page is displayed. Here you may enter the protocol’s primary information,
such as the protocol number, title, treatment type, and accrual goals. Protocol No., Library,
Department, Organizational Unit, and Protocol Type are required fields.
3. Enter the following data:
Health Affairs
Protocol No. : PROT-your initials
Library: Health Affairs
Department: SOM-Surgery
Organizational Unit: Health Affairs
Title: Training Protocol for your name
Short Title: Protocol for your name
Phase: Phase II
Scope: National
Age: Adults
Investigator Initiated Protocol: Yes
Summary Accrual Info Only: No
Protocol Type: Treatment
Oncology
Protocol No. : PROT-your initials
Library: Oncology
Department: Cancer Clinical Trials Office
Organizational Unit: Cancer Center
Title: Training Protocol for your name
Short Title: Protocol for your name
Phase: Phase II
Scope: National
Age: Adults
Investigator Initiated Protocol: Yes
Summary Accrual Info Only: No
Protocol Type: Treatment
Protocols │ 1 of 19
Protocol Target Accrual: 70
RC Total Accrual Goal (Upper): 100
Accrual Duration (Months): 16
Primary Completion Date: y+2
Anticipated radio button
Data Table 4 Report Type DT4*: Interventional
Protocol Target Accrual: 70
RC Total Accrual Goal (Upper): 100
Accrual Duration (Months): 16
Primary Completion Date: y+2
Anticipated radio button
4. Click the Submit button to create the protocol.
You are returned to the PC Console, where the header displays your protocol number and a
Protocol Status of New. Additional protocol information can now be entered.
Defining Additional Protocol Data
The next set of instructions expands your protocol definition. (Note that the Main vertical tab is
currently selected).
Management
1. Select the Main > Management tab. Here is where you enter administrative data for the
protocol.
Some fields of note in the Management Details table:
*
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The IRB No, Pharmacy No, PRMS No, and CTRC No store additional protocol
identifiers used by these organizations. These identifiers are matched when using the
Select Protocol browse box.
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For Oncology trials: PRMS Review Required field must be checked Yes.
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Toxicity Scheme - Determines the toxicity scheme used for recording Adverse Events
and Serious Adverse Events (SAEs) on the protocol. Once toxicities have been
recorded for subjects on the protocol, this field is locked. The only change allowed is the
switch from CTCAE v3.0 to CTCAE v4.0 for which there is a mapping.
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Allow On Treatment date to be entered before On Study date - When checked, the
On Treatment Date for the protocol’s subjects can be prior to their On Study Date.
Oncology only field
Protocols │ 2 of 19
2. Click the Update button, if necessary.
At a minimum, enter these values in the Management Details table:
Toxicity Scheme: CTCAE v4.0
Automated Subject MRN: No
Automated Sequence No: Yes
The data stored in the Administrative Groups table is used for reporting and security purposes.
Each group's available selections are defined by Reference Codes. Program Areas and Oncology
Groups will only be available for Protocols in the Oncology Library. Management Groups are
defined for each Organizational Unit.
3. Enter the following data under Administrative Groups section after clicking the Select button
within the category:
Health Affairs
Management Group
In the pop-up window, select the checkbox
for Neuro-GenNeurology and Med-Geriatrics,
then click the Add button.
Oncology
Program Areas
In the pop-up window, select the checkbox
for Cancer Prevention and Control, then
click the Add button.
Management Group
In the pop-up window, select the checkboxes
for CCTO-GU, then click the Add button.
4. Mark the Primary checkbox for these Administrative Group(s):
Health Affairs
Management Group: Med-Geraitrics
Oncology
Program Areas: Cancer Prevention
and Control
Management Group: CCTO-GU
Scroll to the bottom of the page and click the Submit button.
Staff
The Main > Staff page lists the staff for this protocol. You add individuals by Role (drop-down)
and Name (find-as-you-type). To save effort, the Select Team button allows you to select from
the staff that has been assigned to another protocol.
Protocols │ 3 of 19
Note that you have been automatically added as a Protocol Staff with the Protocol Creator
role.
1. Use the Protocol Staff add block to enter Skeps, Raymond as the Principal Investigator
for your protocol. (Be sure to click the Add button).
Sponsor
2. Select the Main > Sponsor tab.
Multiple sponsors can be assigned to a protocol, but only one can be a Principal Sponsor. The
Principal Sponsor is the one displayed on the Data Table 4 Report.
3. Click the Add Sponsor button.
In the newly-displayed add block, use the find-as-you-type data entry field to choose Astex
Pharmaceuticals, Inc.
Click the Add hyperlink.
Your Sponsor has been added.
4. Enter a Sponsor Protocol No. of AZ-9999
Click the Principal Sponsor checkbox.
Click the Submit button.
The Sponsor Protocol Number is another protocol identifier used by the Select Protocol
browse box.
Treatment
The PC Console > Treatment tab is where the protocol’s treatment and Diagnosis (Disease†)
information are entered. There are two horizontal tabs.
1. Select the PC Console > Treatment vertical tab.
2. Select the Details horizontal tab.
†
Oncology library’s description
Protocols │ 4 of 19
Here is where you supply basic information about the protocol’s treatment: the steps, arms,
modalities, drugs, and levels for the Protocol:
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Step –Registration or Randomization as applies to the protocol.
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Arm –Within a Step, one arm or multiple arms may be defined. Every protocol that has
a Calendar requires at least one arm.
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Modalities – The arm’s method of treatment.
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Drugs – The drugs (agents) being administered in the arm. Drugs are important for
correctly identifying Toxicities.
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Devices –The devices being used in the arm.
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Levels – The dosage levels being tested. (Generally applies in Phase I trials when the
maximum tolerable dose is being determined). Note that if one arm has Levels defined,
all arms must have Levels defined.
3. Click Update (if necessary). Enter the following:
Step Code: 1
Randomization checked
Click the Add button
4. For the Protocol Step that has just been added, click the Arms hyperlink. Enter:
Arm Code: ArmA
Arm Description: Arm A
Click the Add button
5. For the Protocol Arm that has just been added, click the Modalities/Drugs/Devices hyperlink.
Health Affairs
In the Modalities section, use the
find-as-you-type field to select Surgery and
click the Add Modality button.
Oncology
In the Modalities section, use the
find-as-you-type field to select
Chemotherapy NOS and click the
Add Modality button.
Protocols │ 5 of 19
In the Drugs section, use the find-as-you-type
field to select the drug Alcortin. Click the
Add Drug button.
In the Drugs section, use the find-as-you-type
field to select the drug Alcortin. Click the
Add Drug button.
Follow the same procedure to add the second
drug rhEndostatin
Follow the same procedure to add the second
drug interferon-alfa-2a
6. Click the Close button.
You are still working within Step 1 of your protocol.
7. Create a second Arm. In the Add Protocol Arm section at the top of the table, enter:
Arm Code: ArmB
Arm Description: Arm B
Click the Add button
8. For Arm B, select the Modalities/Drugs/Devices hyperlink.
Health Affairs
In the Modalities section, use the
find-as-you-type field to select Surgery and
click the Add Modality button.
In the Drugs section, use the find-as-you-type
field to select the drug placebo. Click the
Add Drug button.
Oncology
In the Modalities section, use the
find-as-you-type field to select
Chemotherapy and click the Add Modality
button.
In the Drugs section, use the find-as-you-type
field to select the drug placebo. Click the
Add Drug button.
9. Click the Close button three times.
10. Within the Treatment vertical tab, select the Disease/Diagnosis horizontal tab.
Protocols │ 6 of 19
Here is where you select the protocol’s target diagnosis group (disease site‡). Diagnosis
groups are Reference Codes, for Oncology protocols these choices comes from the Data
Table 3 Disease Site list. More than one Disease/Diagnosis can be chosen.
Click Update then the Select button.
Health Affairs
In the popup window, select the checkboxes
for Diseases Of The Circulatory System and
click the Add button.
Click Close. You should see the Diagnosis
table shown here:
Oncology
In the popup window, select the checkboxes
for Lung and Soft Tissue and click the Add
button.
Click Close. You should see the Disease table
shown here:
Institutions
The PC Console > Institution tab is where you enter the Institutions that will be participating in
the Protocol.
1. Select the Institution vertical tab.
2. Click the Update button (if necessary).
The upper portion of the screen displays the Participating Institutions table. Note that no
Institutions are included by default.
3. Click the Add button at the upper right.
Use the browse box to choose the Colorado Research Center, then click the Save button.
The Colorado Research Center is now listed in the table.
4. Click the Add button again.
‡
Oncology library specific
Protocols │ 7 of 19
Use the browse box to choose the UC Health-Central Region. Note that a checkbox appears
asking if this Institution uses the Research Center (RC) IRB. Select it.
Click the Save button.
Let’s add a second Affiliate Institution.
5. Click the Add button again.
Use the browse box to choose the Children’s Hospital Colorado-A. Do not select the
checkbox asking if this Institution uses the RC IRB.
Click the Submit button.
6. Click the Close button.
Remember that OnCore classifies Institutions into types: Research Center, Affiliate, VA,
Consortium Member, and Office of Clinical Trials (OCT). The OCT is not available as a
participating institution.
Also note that OnCore has different rules for Research Centers vs. Affiliates/Consortium
Member/VA. Because the Colorado Research Center is a Research Center, its status defaults
to the protocol’s status. However, Affiliate, Consortium Member, and VA statuses do not
default (and for all intents and purposes, the VA is considered an Affiliate). Additional
distinctions will be discussed as we encounter them.
Beneath each Participating Institution is a bulleted list of participating Study Sites. The lists
are configurable.
7. Select the Colorado Research Center hyperlink to display the Protocol Institution console.
(Note the institution name in the header.) The Protocol Institution console stores information
relevant to an Institution participating in a particular protocol.
8. Select the Study Sites vertical tab.
9. Click the Update button.
Here you see checkboxes that indicate whether the Study Site is participating in the protocol.
Check the box for CTRC-Adult Study Site and click the Submit button.
The site will now be able to accrue subjects to the protocol.
10. Click the Close button.
Protocols │ 8 of 19
11. Select the PC Console vertical tab to return to the PC Console.
Status
The PC Console > Status tab contains a number of horizontal tabs. The Status tab contains a
table of the history of the status of the protocol. The Checklists tab allows you to configure a
checklist for your protocol. The ClinicalTrials.gov and CTRP tabs list the history of submissions
to CT.gov and CTRP.
Checklists:
Each checklist category displays as a link to view checklist details to users with the associated
privileges.
Info:
Each checklist category will display one of the following statuses:
Blank - The checklist has not yet been started (no checklist information has been entered).
In Progress - The checklist has been started, but is not 'Complete'.
Complete - The checklist has been marked as 'Complete'.
NA - The checklist has been marked as 'Not Applicable'.
Reviews
The PC Console > Reviews tab is where you can view and update review information from
various committees.
1. Select the PC Console  Reviews tab.
There are a number of horizontal tabs. The Summary tab is a read-only summary of the data
on the other horizontal tabs.
An IRB Review is required by OnCore.
A PRMS Review is required for Oncology studies.
All other reviews are configurable, and are informational only.
PC Console > Reviews > PRMS
2. Select the PRMS horizontal tab.
Protocols │ 9 of 19
Scientific review information is entered on the PRMS tab. (If this page displays a Submit button
but no way to enter data, it is because ePRMS is enabled on your system.)
For Oncology Studies: we will now enter PRMS Review information. (FYI, the process is
nearly identical to entering IRB information, which we will now do.)
PC Console > Reviews > IRB
3. Select the IRB horizontal tab.
For Non-Oncology Studies: This is the only Review that is required by OnCore – all other
Reviews are optional and/or configurable.
A PRMS Review is required for Oncology studies.
Here we find an OnCore distinction between the Research Center and Affiliates. This tab is
used to record the Colorado Research Center’s IRB information. Affiliate IRB information (if the
Affiliate is using their own IRB for the protocol) is recorded on the Protocol Institution →
IRB Reviews tab.
Currently, you have no Research Center IRB Review data entered, so nothing displays.
4. Click the Add button.
You are presented a screen to enter the details of an IRB Review.
5. Click the down arrow in the Review Date field.
This field holds the date the IRB reviewed the protocol. It is good practice to use the down
arrow to see if your date has already been entered. If not, you can enter a date. (Note that this
field does not have "date widget" functionality – you will need to enter a date using the
MM/DD/YYYY format.)
6. Select (or enter) a Review Date from early January of 2013.
7. Enter the following data:
Submit Date: Enter a date that is one day prior to the Review Date
Committee: COMIRB Panel A
Review Reason: Initial Review
Review Type: Full
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Action: Approved
Action Date: Enter the value stored in Review Date
Expiration Date: Enter a date one year after the Action Date
8. Click the Submit and Close button to return to the PC Console.
You can see that the Protocol status has changed to IRB Initial Approval. (This status is only
achieved when the Review Reason is 'Initial Review', the Action is 'Approved', and an Action
Date is entered.)
Consents
9. While remaining on the IRB horizontal tab, select the Edit hyperlink for the IRB Review you’ve
just entered.
In the Details table, you may add additional data about the IRB Review. This table is used to
record approved Consent Forms and to record Amendments. Approving Consent Forms is a
prerequisite to the Subject Registration process.
10. Click the Add button in the Details table. Enter the following:
Type: Main Consent
Version Date: Same as Action Date above
Description: Tx Consent V1
Click the Save hyperlink.
You can attach a corresponding document within the review.
11. Click the File hyperlink. Use the browse button to find your document, then click the Submit
button to attach it.
Once a document is attached, you can access the document from within this page.
12. Check the Release checkbox and click the Submit and Close button.
Once a document is released, it can be searched for using Document Search. In addition,
documents attached to a Details Type of Consent will display in the Consent Forms tab for the
Research Center (PC Console → Institution → Institution hyperlink → Consent Forms).
Documents attached to a Details Type of non-consent will display in the PC Console →
Documents/Info tab.
Protocols │ 11 of 19
13. Click the Institution tab.
Notice that IRB dates appear for the Colorado Research Center, but do not for the UC HealthCentral Region – even though the UC Health-Central Region has been configured to use the
Research Center IRB. An additional step is necessary to “pass along” the IRB decision and
consent documents to the UC Health-Central Region.
14. Click the Reviews tab, then select the IRB horizontal tab.
15. Click the Edit Hyperlink for the IRB Review entered earlier.
16. In the upper table, click the Edit hyperlink that appears in the last row, just after the Institution
name.
A pop-up window will appear.
Select UC Health-Central Region and click the Submit button.
This will “pass along” this IRB review to the institution (note the last row of the upper table).
17. Click the Close button.
18. Click the Institution tab.
The same IRB dates appear for the Colorado Research Center and the UC Health-Central
Region. If you select the UC Health-Central Region hyperlink to display the Protocol Institution
console, the IRB Reviews and Consent Forms tabs will display the information entered for the
Research Center IRB. The protocol status for UC Health-Central Region has not been
updated, though.
19. Select the Children’s Hospital Colorado-A hyperlink.
The Protocol Institution console displays. Here we can record IRB Initial Approval for this
Affiliate, which has its own IRB.
20. Select the IRB Reviews tab.
21. Click the Add button (either one!).
The process to add an IRB Review for an Affiliate is the same as for the Research Center.
22. Enter a Submit Date from early January of 2013.
23. Enter the following data:
Protocols │ 12 of 19
Review Reason: Initial Review
Review Type: Full
Action: Approved
Action Date: Enter the value stored in Submit Date
Expiration Date: Enter a date a year after the Action Date
24. Click the Submit button.
In the Details table, you may add additional data about the IRB Review. This table is used to
record approved Consent Forms and to record Amendments. Approving Consent Forms is a
prerequisite to the Subject Registration process.
25. Click the Add button in the Details table. Enter the following:
Type: Main Consent
Version Date: Same as Action Date above
Description: Affiliate Tx Consent V1
Select the Save hyperlink.
26. Click the Close button.
You’ve now saved the IRB Consent information for this Institution on this protocol.
27. Select the PC Console vertical tab to return to the PC Console.
Reconsent
When there is an amendment that requires reconsenting subjects, it can be entered as a new IRB
review where the Review Reason is Change Review. The consent is entered in the Details table
and the Reconsent Required? checkbox is checked. This will show an RR indicator in the review
and on the subject MRN in the CRA Console. The indicator will also show on the consent
document in the Subject Console until consent for the newer version has been recorded for the
subject.
Opening the Protocol to Accrual
Once a protocol has IRB approval it can be opened to accrual.
Protocols │ 13 of 19
Your organization may have intermediate steps between these two milestones. For example, you
may require signoffs from the CRA, DM, PC, etc. These steps can be configured in OnCore. If
configured, users with the appropriate privileges then enter records of these signoffs from the PC
Console  Status tab.
Opening the Protocol at the Research Center
1. Select the PC Console  Status vertical tab.
If an additional signoff has been configured, a corresponding Signoff button will display.
2. Click the Pre Award Signoff button.
All that is required for an additional signoff is the entry of the signoff date.
3. Enter a Status Date of 02/01/2013.
4. Click the Submit button.
The Protocol Status table will redisplay with the updated information. Note the change in
Protocol Status in the console header.
5. Repeat steps 2-4 for all additional signoffs, making sure to enter a date no earlier than the
previous signoff date, but before 02/15/2013. Continue until the Open button appears.
When the Status tab presents the Open button, you are ready to make the protocol Open For
Accrual.
6. Click the Open button.
7. Enter a Status Date of 02/15/2013.
Click the Submit button.
Note the change in Protocol Status – your protocol is now Open To Accrual!
8. Click the History button at the top of the Protocol Status table.
A list of Status History appears, including the name of the OnCore user that entered the
statuses.
9. Click the Close button.
Protocols │ 14 of 19
Opening the Protocol at an Affiliate
We've just seen the process for opening the Protocol to accrual at the Research Center. This
does not affect Affiliate Institutions. (If you go to the PC Console → Institution tab, you'll see no
status for the Affiliates.)
To make the protocol Open for Accrual at the UC Health-Central Region affiliate:
1. Select the Institution vertical tab of the PC Console.
2. Select the UC Health-Central Region hyperlink to display the Protocol Institution console.
3. Select the Status vertical tab.
Click the Update button and enter the following:
Status: Open to Accrual
Status Date: 02/15/2013
Click the Add button
Note the console header. There is now an Institution Status displayed.
4. Return to the PC Console (use the vertical tab).
The protocol is now listed as Open To Accrual at the Affiliate institution.
5. Repeat steps 2-4 for all other Affiliates.
Documents/Info
The PC Console → Documents/Info tab provides the ability to attach protocol related documents,
record protocol FAQs, and record document archive information. This page automatically displays
released (non-Consent) documents that were uploaded to an IRB review. Documents not subject
to approval by the IRB may be uploaded directly to this page.
Note: Documents approved by an IRB should not be uploaded here. The Research Center IRB
documents should be attached within an IRB review record. Documents specific to a participating
institution or approved by an outside IRB should be attached to the protocol institution record.
Protocols │ 15 of 19
Documents
1. Select the Documents/Info vertical tab.
The Attachments horizontal tab will be selected.
2. Click the Update button, then the Add button that appears at the upper right.
3. Select Study Schema form from the Document Type drop-down.
4. Click the File link, then use the Browse button to choose a file to represent the Study
Schema.
5. Enter a version date of 01/02/2013.
6. Enter a Description of Study Schema.
7. Click the Add button.
Continuing on the Documents/Info vertical tab:
8. Click the Add button.
9. Select Protocol from the Document Type drop-down.
10. Click the File link, then use the Browse button to choose a file to represent the Protocol
document.
11. Enter a version date of 01/02/2013.
12. Enter a Description of Protocol Overview.
13. Click the Add button.
A document has now been attached to the protocol so that others can reference them as
needed.
FAQs
The FAQ (frequently asked question) section is used as a reference to assist staff. Common
questions and answers regarding the protocol, subject eligibility, subject treatment, and so on may
be entered here. FAQs are available for staff to view from the Subject → CRA Console.
1. Select the FAQs horizontal tab.
Protocols │ 16 of 19
2. Click the New button.
3. In the Question section, enter the text “Where can I find documentation on OnCore?”.
4. In the Answer section, enter the text “At the Learning Portal found via the question marks in
OnCore, the Help dropdown or www.onsemble.net”.
5. In the Keywords section, enter the text “OnCore documentation”.
6. Click the Submit button.
Your entry will be displayed.
Archive/Notes
1. Select the Archive/Notes horizontal tab.
The purpose of the Archive Details section is to record storage details of protocol documents.
The Notes Details section provides the ability to enter any number of dated Notes related to
the protocol.
2. Click the Update button, if necessary.
3. In the Notes Details section, click the Add button.
4. In the date field, enter 01/10/2013.
5. In the text entry field, enter “Due to staffing issues, limit the number of subjects added in
December”.
6. Click the Save hyperlink.
7. Click the Close button.
Note the Protocol No. display at the upper left of the page. A document icon now appears
followed by the number 1, indicating that one note has been added to the protocol. Users may
click the hyperlink to display the Archives/Notes page.
Annotations
Protocol Annotations are fields are created to record additional protocol information that is not in
the standard OnCore fields, but is desired by the organization. The fields should be recorded
according to the organization’s SOP.
Protocols │ 17 of 19
Protocol annotations are configured for each Library, which defines data fields within a dedicated
OnCore Form. The fields in this “annotation form” are available for the library’s protocols on the
PC Console → Annotations tab.
When initially landing on this page, the annotation form doesn’t show. It needs to be created in
order to use the fields for this protocol. Click the Update button, then click the Create Annotation
Form link to view the annotation fields.
Deviations
The PC Console  Deviations vertical tab contains two horizontal tabs.
1. Select the Deviations vertical tab.
The Protocol Deviations horizontal tab allows creation and modification of protocol
deviations. The Subject Deviations horizontal tab allows modification of subject deviations.
Protocol Deviations
2. Select the Protocol Deviations horizontal tab, if necessary.
3. Click the New Protocol Deviation button displayed at the top of the Protocol Deviations
Overview table
A page is displayed to collect information about the deviation. Deviation Date and Category
are required fields.
4. Enter the following:

Date Discovered – 05/15/2013

Reported By – keep default

Deviation Date – 05/03/2013

Category – Treatment

Description of Deviation – Example of protocol deviation

Effect on Patient Safety – None

Action Taken – Re-evaluation of protocol processes

Did the deviation put… – leave unchecked
Protocols │ 18 of 19
Note the additional data entry fields at the bottom of the page, which are used to record
reporting information.
5. Click the Submit button.
6. Click the Close button.
The PI Report button will generate a report of deviation data in the format specified by the
preceding drop-down selection field.
7. Select the Protocol Deviations horizontal tab (or the Deviations vertical tab).
The protocol deviation is displayed in the Protocol Deviations Overview table.
At the bottom of the page is the Update Selected IRB Reported Dates field. Multiple
deviations may have their Date Reported to IRB field filled in by entering a date in this field,
selecting the appropriate deviation checkboxes, and clicking the Update button.
The list of deviations may be filtered by checking the Show Only Unreported Deviations
checkbox.
Subject Deviations
8. Select the Subject Deviations horizontal tab.
Subject deviations initially recorded in the Subject Console can be viewed and edited here.
The procedures are identical to those of protocol deviations.
Protocols │ 19 of 19
Notifications
Notifications are e-mails that are triggered by various actions in the system. Some are triggered
manually by clicking a hyperlink, some are triggered when you perform a specific action, and
others are triggered by a scheduled batch process that periodically checks for new information to
send. The general settings for notifications are made in the libraries, however, these settings can
be overridden at the protocol level. The library set-up for notifications was covered in the
Administration training session. In this session, we’ll present the settings and configurations that
can be made at the protocol level.
Protocol Notification Configuration
Within each protocol, you can determine whether to respect the library-wide setting, override it
with a custom setting, or disable individual notifications.
Configuration
1. Display the Protocol Notification Configuration page via the Protocols  PC Console 
Notifications page.
The notifications are listed on the page with three radio buttons for Default, Custom, and
Disable. To use the notification setting from the library record, leave the Default radio button
selected. To prevent the notification from being sent for the protocol, select the Disable radio
button. To override the library’s notification setting, select the Custom radio button.
2. Select the Custom radio button for the Protocol Closure Notice.
A Not Configured message will appear to the right of the radio buttons letting you know that
you need to set up the custom override.
3. Click the Protocol Closure Notice hyperlink.
4. Click the Edit button.
The process of configuring a protocol notification is identical to the process presented in the
Administration training session. As a reminder:
 The Reply To, To, and CC fields at the top can be used to type in e-mail addresses.
The Reply To field should always be filled in. If you want multiple hard-coded e-mail
addresses in the To or CC fields, they should be separated with semicolons.
Notifications │ 1 of 5
 When the notification is sent, staff e-mails can be looked up according to their Role as
Protocol Staff or Subject Staff. This Add Block can be used to define the generic
recipients of the notification.
 Some notifications have pre-defined information, such as the protocol number, title,
accrual, etc. They also have fields for entering your own information related to the email being sent.
 When participating affiliates are included in the notification, the e-mail is sent to the email address of the institutions in the protocol.
5. Add your e-mail address to the Reply To and To fields. You may add additional information if
you wish, following the instructions from the Administration session. When you have
completed configuring this protocol notification, click the Submit button.
6. Click the Notifications tab after submitting your configuration.
You will notice that the Not Configured message no longer appears.
Notification Rules
Certain notifications are triggered by rules that are set up in the protocol. The four groups of rules
are Protocol Monitoring Rules, Low Accrual Rules, Subject Status Rules, and Subject Visit
Duration Rules. Hyperlinks for these rules are found at the bottom of the Notification page.
Protocol Monitoring Rules
Protocol Monitoring Rules can be set up to trigger the Safety Monitoring Notice when SAEs
are entered for the protocol. There are many options for the rules. We’ll set up a rule that sends a
message for each unexpected SAE.
This section assumes that you are on the PC Console  Notifications tab.
7. Click the Protocol Monitoring Rule hyperlink.
The existing monitoring rules are displayed on the page. They may be active or not. The
system-wide settings are listed in the upper table and any protocol rules are listed in the table
at the bottom.
8. Click the Update button.
9. Click the Add button in the Protocol Monitoring Rules section.
10. Enter the following data, then click the Save hyperlink:
Notifications │ 2 of 5





No. of SAEs: 1
Toxicity: Unexpected
Grade: 0
No. of Subjects: 1
Active: check the checkbox
After saving the first protocol rule, a Rule Attribute dropdown appears in the table header
space. The protocol rule(s) may either be in addition to the system-wide rules or may override
them.
11. Enter the following data, then click the Submit button:

Rule Attribute: Override Rule
After setting the protocol rule to override the system-wide rules, the system-wide rules are
suppressed and you will only see the protocol rules.
Low Accrual Rules
Low Accrual Rules can be set up to trigger the Low Accrual Study Notification when a
protocol’s accrual has not reached a predefined level a number of months after the Open to
Accrual date. The notification can be configured to send multiple times if the accrual continues to
be below the threshold.
This section assumes that you are on the PC Console  Notification tab.
1. Click the Low Accrual Rule hyperlink.
2. Click the Update button.
3. Enter the following data, then click the Submit button:



§
Accrual Institution: Research Center (Cancer Center§)
Accrual Duration (Months): 3
Low Accrual Threshold: 10
Oncology protocols
Notifications │ 3 of 5
The rule just entered will trigger the notification three months after the research center’s Open
to Accrual date if the research center accrual is not at least 10 subjects. This rule is not related
to the target accrual fields from the PC Console  Main  Details tab.
In order to use this notification, the Low Accrual Study Notification must be customized for the
protocol.
4. Click the Back button to return to the PC Console.
You should be back on the Notifications tab.
5. Click the Low Accrual Study Notification hyperlink.
Within the configuration of the Low Accrual Study Notification, you can send the notification
multiple times by entering the number of days after the time period elapses (multiple entries
are separated by commas). To send the notification on the day the rule is first checked, the
Send On Day(s) setting in the notification should be set to zero.
Subject Status Rules
Subject Status Rules can be set up to trigger the Subject Status Rule [<status>] Notice when
thresholds of subject statuses are met. They can be configured to send the first time the threshold
is hit, and again for each subject after or again for the next group of subjects.
This section assumes that you are on the PC Console  Notification tab.
1. Click the Subject Status Rules hyperlink.
2. Click the Update button.
3. Enter the following data, then click the Add hyperlink:



Status: CONSENTED
Subject Threshold: 5
Repeat: When 5 more subjects become CONSENTED
The rule will trigger the Subject Status Rule Notice that corresponds to the status selected in
the Status dropdown field. In this instance, the rule will trigger the Subject Status Rule
[CONSENTED] Notice notification after the first five subjects have been given a Consented
Date. Then it will trigger the same notification for every five subjects who are given a
Consented Date after that. Combining the different statuses, thresholds, and repeat choices
gives you many options for the notifications.
Notifications │ 4 of 5
Subject Visit Duration Rules
Subject Visit Duration Rules can be set up to trigger the Subject Visit Duration Notice when a
subject has one status date, but not another within a configured time period. For example, when
the subject should go On Treatment within some number of days after the Consent Signed Date
and does not. The status dates and time period rules are configured per protocol.
This section assumes that you are on the PC Console  Notifications tab.
1. Click the Subject Visit Duration Rules hyperlink.
2. Click the Update button.
3. Enter the following data, then click the Add hyperlink:




Begin Visit: ON STUDY
End Visit: ON TREATMENT
Max. Duration (Days): 14
No. of days after Begin Visit to send notification: 12
The rule will check subjects on the protocol and see if they have an On Study Date without an
On Treatment Date. If they do and 12 days have elapsed after the On Study Date, the
notification e-mail will be sent. This is a one-time notice (it will not be re-sent).
Notifications │ 5 of 5
Subject Administration
The primary focus of this section of training is on subjects. In OnCore, a subject is a person who
is participating in a protocol or may participate in a protocol.
Consoles
There are two Consoles used in subject management - the CRA Console and the Subject
Console.
The Subject Console is designed with a subject focus. The console provides access to a subject’s
demographic information, the protocols the subject is associated with, what consents the subject
has signed, what is their eligibility status, etc.
The CRA Console is designed to provide subject information at a protocol level. When a protocol
is selected in the CRA Console, it displays the subjects that have been accrued, which subject
forms have been completed and are yet to be completed, a list of Serious Adverse Events (SAEs),
visits outside of tolerance and other subject deviations in this protocol.
It is quite easy to move from one Console to the other. The CRA Console lists the subjects
associated with the current protocol, and each subject has a link to display the subject in the
Subject Console. Conversely, the Subject Console has a vertical tab to transfer to the CRA
Console.
We will move between these Consoles as we discuss Subject Management. We will discuss the
basic tasks when dealing with a Subject - registering the subject, logging consent information,
placing them on study. One important part of this discussion will be entering data, especially key
dates.
Creating a New Subject
Our first task will be to create a new subject. Subjects must be associated with a protocol.
1. Select the Subjects  CRA Console menu link.
2. Use the Select Protocol Find-As-You-Type field to locate the protocol that you created earlier.
The CRA Console finds the protocol and displays the protocol’s Accrual information (note the
highlighted vertical tab).
3. Click the New Subject Registration vertical tab.
Subject Administration │ 1 of 13
You are presented with a screen to enter the subject's information. Note that you are working
in the context of your Protocol - you cannot enter a subject into OnCore without a protocol
association!
The first entry field is Study Site. Here you enter the institution where the subject is being
enrolled. This is a find-as-you-type field, and allows you to choose from the Study Sites that
are participating in this protocol at your institution (or an institution with which you are
affiliated).
4. In the Study Site field, choose the CTRC-Adult.
When entering a new subject, it is a good idea to see if they have already been entered into
the OnCore system. You'll avoid duplicate subject entries.
On the left side of the page you may enter a Subject's MRN, last name, and birth date, etc.
Use the Find button to list the subjects in the system that match this data.
5. Enter the Last Name Smith and click the Find button.
A list of results appears. If any subject matches are found, they display with hyperlinked
Subject MRN values. Selecting a hyperlink will populate the fields in the New Subject screen
with that subject’s data. We will not select from this list – we will enter a brand new subject.
6. Click the Clear All button.
7. In the Study Site field, choose the Outstanding Research Center.
8. Enter the following into the New Subject Details table (asterisks next to the screen prompts
indicate required fields):







Subject MRN: Your Initials123 (e.g. JFK123)
Last Name: Initials
Birth Date: Your choice
First Name: Your choice
Gender: Your choice
Ethnicity: Your choice
Race: Your choice
It is possible to have the Subject MRN label appear differently. If you do not want this identifier
to be referred to as an MRN, consult your Forte Project Manager. In addition, it is possible to
have the SSN field hidden in the system if you do not want to collect this information.
9. Click the Add button to register the new subject to the Protocol.
Subject Administration │ 2 of 13
When you add the subject, you are taken to the Subject Console.
Subject Demographics information is at the top of the page. One field in particular, Expired
Date, may drive some functionality. With the system configured to do so, entering an Expired
Date can cause that date to cascade down to the Off Treatment Date and Off Study Date
fields. It will also do the same for other protocols the subject is on at the time. This is an
optional feature.
Additional Subject Identifiers Table
The Additional Subject Identifiers table holds identifiers for the subject other than the MRN. The
Identifier Type is selected from a pre-defined list (a Domain), and free text can then be entered for
the Identifier and Identifier Owner. An example of this is a Hospital ID from another system.
Subject Contact and Emergency Contact Information
The final tables on the Demographics tab hold subject Contact Information, such as address,
phone number, and e-mail address, and the Subject’s Emergency Contacts. This information
may be kept in OnCore or it may be kept in another electronic registration system.
Information entered on the Subject Console > Demographics page is not protocol specific and
editing this page will update the subject’s information on all protocols to which they have been
assigned.
Entering Subject Consent
In the Subject Console header area it displays the Protocol, Protocol Status, the Subject's MRN
and Subject Name. Note that the subject has yet to be assigned a Subject Status, thus next we
will demonstrate how to set the subject’s status indicating they have consented to the protocol.
10. Select the Consent vertical tab.
The Existing Consents section will list signed Consent forms - as this is a new registration, no
Consent Forms have yet been signed.
11. Click the Select Consents button in the Available Consents table to display a list of consents.
The list will show the available Consent Forms for the subject that have been approved at the
subject’s study site and added at the protocol level via PC Console > Reviews > IRB record
or if an affiliate study site, Institution > *Pick an Institution* > Consent Forms tab.
12. Enter a Signed Date of 02/20/2013.
Subject Administration │ 3 of 13
13. Click the Accepted radio button.
14. Click the Save button.
The Consent Form information is displayed along with the subject's Signed Date. Note that the
Subject Status has been updated to CONSENTED.
The Other Consent Status table is used to record comments related to consent information, record
consents being refused or waived or withdrawn, and record when a minor subject has been
reconsented when they reach the legal age limit.
15. Click the Close button.
Reconsents
When a newer consent is available for a subject to sign (a new consent was approved with a
“Reconsent Required” indication), an RR superscript will appear next to the consent type
(e.g. Treatment ConsentRR). This superscript will also appear next to the Subject MRN on the
CRA Console  Accrual list. In a reconsent situation, OnCore does not restrict the subject from
receiving treatment.
To deal with a reconsent situation, follow the procedure described above and add the newer
version of the consent for the subject.
If the newer version of the consent is not applicable to this subject's situation, you can go to the
Subject Console  Consent tab and select the consent hyperlink that includes the RR
superscript. A box will appear allowing you to specify that reconsenting is not applicable. If you
make this choice, the superscript will changed to “N/A” (e.g. Treatment ConsentNA).
Subject Eligibility
Confirming subject eligibility is not required by OnCore before a subject goes On Study, but it is
usually done.
16. Select the Eligibility vertical tab.
The Eligibility tab is used in one of two ways:


If the protocol has defined an eligibility questionnaire to assist in determining eligibility
status, the tab provides a way to supply answers to eligibility questions.
If there is no eligibility questionnaire, the tab can be used to directly enter the eligibility
status.
Our Protocol does not have a questionnaire.
Subject Administration │ 4 of 13
17. Enter the following:



Verified By: enter your initials
Status Date: 02/24/2013
Eligibility Questions: answer so subject is Eligible
18. Click the Submit button.
Note that the Subject’s Status has been changed to ELIGIBLE.
19. Click the Close button.
Subject On Study
Our subject has Consented, and is deemed Eligible. Now let’s place our subject On Study.
20. Select the On Study vertical tab.
21. Click the Update button.
Subject On Study Update Table
In the top table, the first field is Sequence No. This is a unique number identifying a particular
subject accrued to a protocol. It may be manually entered, or OnCore can automatically generate
it. Manual entry is generally used for co-op studies (in which you receive a sequence number from
the co-op group). Automatic sequence numbering will occur if the protocol has been set up that
way. (This is the case for our training protocol, and the reason that no entry field is provided.)
Automated Sequence Numbers start with the value 1 by default, but the numbering scheme can
be designated by the protocol.
One of the most important fields is On Study Date. When this is filled in and the data is submitted,
the subject is considered Accrued to the study.
22. Enter an On Study Date of 02/26/2013.
The Diagnosis (Disease Site and Histology**) fields are dropdown selections based upon the
protocol definition (values entered in the PC Console  Treatment  Diagnosis tab). The
values that appear in the case of an Oncology protocol are defined in the NCI Data Table 3
Primary Disease Site mapping guidelines.
**
Oncology library specific
Subject Administration │ 5 of 13
Non-Oncology
Select Heart Disease-Unspecified for
Primary Diagnosis.
Oncology
Select the Disease Site Bronchus and Lung
Select the Histology Carcinoma, NOS
Leave the Secondary Diagnosis field bank or
click into the dropdown and select the View
All link. This will bring up a popup box of all
Diagnoses – choose one.
The Oncology Group dropdown list allows you
to select an oncology group that will receive
accrual credit for the subject. It defaults to the
‘Primary’ oncology group indicated on the
PC Console  Main  Management tab.
The Study Site field will populate with the Study Site selected during the New Subject Registration
entry. The study site browse will display all the study sites participating in the study.
The Transferred Date can be used to indicate the date that a subject, who was enrolled on the
protocol at another Institution, was transferred to the Study Site.
23. Click the Submit button.
Note that the Subject’s Status has been changed to ON STUDY and a Sequence Number has
been assigned.
Additional Protocol Subject Identifiers Table
The Additional Protocol Subject Identifiers table holds identifiers for the subject applicable to this
protocol. The Identifier Type is selected from a pre-defined list, and free text can then be entered
for the Identifier.
Subject Staff Table
The Subject Staff table holds information about the treatment staff assigned to the subject.
24. Select the following (Staff Name is a find-as-you-type field):


Role: Treating Physician
Staff Name: Raymond Skeps
Click the Add button.
When a staff member has been added as subject staff, their name displays as two hyperlinks.
In view only mode, selecting the hyperlink displays the staff members contact information
(phone number and address). In update mode, selecting the hyperlink displays a screen
Subject Administration │ 6 of 13
where the staff member can be deleted or additional staff data (Stop Date, Stop Reason)
added.
Clicking the See All button will display additional fields (including a Stop Date and Stop
Reason), as well as show staff with a past Stop Date.
The Team button allows Subject Staff to be created from the already-defined Protocol Staff list.
25. Add yourself as a subject staff with the Clinical Research Associate role.
Subject On Treatment
In the Subject Console, the Treatment tab is where you select the protocol Arm assigned to the
Subject. You can also enter additional dates that are used in subject visit scheduling.
26. Select the Treatment vertical tab.
27. Click the Add button at the upper right.
A table displays where you can choose the Arm from a dropdown list. Additional fields are
provided that may be necessary for subject visit scheduling: On Arm Date, On Treatment
Date, and Off Arm Date.
28. Select/enter the following:



Arm: Arm A
On Arm Date: 02/28/2013
On Treatment Date: 02/28/2013
Click the Save hyperlink.
Note that the Subject’s Status has been changed to ON TREATMENT.
As you’ve been doing these steps, visits have been populating on the subject’s calendar (if a
calendar has been created for the protocol). The calendar visits will be relative to the dates
entered for each individual subject.
Subject Administration │ 7 of 13
Off Treatment, On Follow-Up, and Off Study
Additional subject statuses are available after On Treatment. They are: Off Treatment, On Follow
Up, and Off Study. These can also be triggers for visit sections in the subject calendar. If the protocol
doesn’t have a follow up portion, the On Follow Up status isn’t required.
We will see how to enter these statuses as an exercise, but will remove them afterwards to avoid
problems with the subject calendar.
29. Click the Follow-Up vertical tab.
Four tables display. The first three store information relevant to the statuses.
30. Click the Update button (if necessary).
31. Enter an Off Treatment Date of 04/01/2013 and click the Submit button.
Note the change in subject status – they are now OFF TREATMENT. This table also holds a
field for the Off Treatment Reason and a field for a free-text note.
32. Enter a Follow-Up Start Date of 04/15/2013 and click the Submit button.
Note the change in Subject status – they are now ON FOLLOW UP.
If you are using a protocol calendar, treatment visits with Planned Dates after the Follow-Up
Start Date will no longer be available to be checked in.
There are many fields in the Subject Follow-Up Update table. A few are related to tracking
follow-up when there isn’t a calendar and others are related to the last known status of the
subject. The Expired Date field appears here in addition to being on the Demographics tab.
33. Enter an Off Study Date of 05/01/2013 and click the Submit button.
Note the change in subject status – they are now OFF STUDY. This field should be filled in for
subjects when they go off study or when they expire. The table contains two fields similar to
the Off Treatment table: Off Study Reason and a free-text note field.
You do not want your subject to be Off Study at this point, however.
34. Remove the Off Treatment Date, Off Study Date, and Follow-Up Start Date and any
Reasons you may have entered. Then, click the Submit button.
Subject Administration │ 8 of 13
The Subject’s Status has returned to ON TREATMENT.
Serious Adverse Events
Serious Adverse Events (SAEs) must be entered at the subject level via the Subject Console 
SAEs tab.
1. If you are in the Subject Console, click the SAEs vertical tab. (If you are not on the Subject
Console, go to the Subjects  CRA Console menu item, enter your protocol number, and
select your subject from the Accrual vertical tab. Then click the SAEs tab.)
2. Click the New button to create an SAE.
You are presented with a screen full of data entry fields. (The ? help icon in the upper right corner
directs you to the Learning Portal SAE page and helps define these various fields). In this upper
section, the fields with an asterisk are required before submitting.
3. Enter the following:
Event Date: 04/01/2013
Reported Date: 04/04/2013
Protocol Attribution: Possible
Outcome: Recovering/Resolving
The Event Date has to be on or after the Consent Date for the subject.
The SAE Classification is not required. If you decide to fill in this area (by clicking into the field), you
are presented with a list defined in Reference Codes.
The Toxicity area is not required. If you decide to fill in this area, you will need to supply all the
asterisked fields (be sure to click the Add button!). You may provide multiple entries.
The Tracking Details table is where you can record the dissemination of information regarding the
SAE.
4. Click the Submit button.
Once the SAE is correctly submitted, an Event Number will be assigned. This is a unique
number for the SAE, and displays at the top of the upper table.
The Additional SAE Identifiers table (shown at the bottom of the page) can be used to record
other identifiers for the SAE, such as a number assigned by the IRB. An Identifier Type can
Subject Administration │ 9 of 13
be selected from a pre-defined list, and the Identifier and Identifier Owner can be entered as
free-text before clicking the Add hyperlink.
Documents relevant to the SAE can be added under the Supporting Documents section by
clicking the Add button.
SAEs can be locked when you are finished entering them using the Complete and Lock
button. After it has been locked, you will still be able to update the Tracking Details section of
the SAE and will be able to create a follow-up SAE.
5. Click the Complete and Lock button.
6. Select the SAEs vertical tab.
Now that you have created an SAE, the tab displays a table with your entry. The table lists the
protocol Arm that the subject is on.
7. Click on the SAE’s Event No. hyperlink to return to the SAE.
At the bottom of the page is the Create Follow-Up button. This button will create a follow-up
SAE, copying most of the SAE information you've supplied and will allow you to make
modifications (usually the change in Outcome).
8. Click the Create Follow-Up button.
A follow-up SAE is created and a new Event No. is assigned to it. The Event No. of the
‘parent’ SAE displays next to it in parentheses. The Follow-Up Number is shown toward the
right side of the small header band.
9. Enter the following:
Reported Date: 04/10/2013
Outcome: Intervention for AE Continues
10. Click the Submit button.
11. Click on the SAEs vertical tab.
Note the Event Numbering of the SAE and its parent.
The follow-up SAE has a Delete hyperlink to the right side, but its parent does not. When
SAEs are to be deleted, they have to be deleted in the reverse order of when they were
created so a hole isn’t left in the sequence.
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Subject Deviations
A deviation is a variance from the approved Protocol procedures. Deviations are entered at the
subject level via the Subject Console > Deviations tab.
1. If you are on the Subject Console, click the Deviations vertical tab. (If you are not on the
Subject Console, go to the Subjects  CRA Console, enter your protocol number, and select
your subject from the Accrual vertical tab. Then click the Deviations tab).
The top table on the page shows the subject’s deviations. The bottom table shows any visits
with a visit date outside of the planned date’s tolerance. This table is for informational
purposes and you can use it as a guide for entering deviations if needed.
2. Click the New button to create a Deviation.
The Date Discovered and Reported By fields default to the current date and user, but may be
changed. When entering Deviation data, the required fields are marked with an asterisk.
3. Enter the following:
Date Discovered: keep the default (the current day)
Reported By: keep the default (your user name)
Deviation Date: 05/10/2013
Category: Treatment
Description of Deviation: Missed a procedure on a visit
4. Click the Submit button to create the Deviation.
Other information may be entered to record when it should be reported to IRB, the date it was
reported, and the date it was reported to the sponsor.
5. Click the Deviations vertical tab to see the updated display.
The Deviation has a Delete hyperlink to the right side for removing those entered in error.
Pre-Screening Console
OnCore supplies a way to track pre-screening efforts for potential subjects and the time spent
pre-screening these candidates. The information captured includes subject referral data, subject
characteristic data, and protocol evaluation specifics.
1. Select the Subjects  Pre-Screening menu item.
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Your initial page is a search screen. We will return to this shortly.
2. Click the New button to create a new pre-screening record.
The Referral Information table is where you can record Referral and Contact Information. The
fields are straightforward. The Contact Date is required.
3. Select a Management Group.
4. Enter today’s date as the Contact Date.
5. In the Referral Channel field, select Newspaper.
A new entry field will appear, allowing you to supply which Newspaper was used.
6. Select an item from Referral Details.
The next section records Subject Characteristics. All data entry fields are optional.
7. Enter a Subject Identifier and select one or more Race checkboxes.
8. Click the Submit button.
After the potential subject has been evaluated, evaluation data can be entered in the bottom
portion of the screen.
9. Select Yes for Subject Evaluated?
10. Select your protocol number in the Protocol No. field.
11. Select Yes for Subject Consented?, then click elsewhere in the screen.
When a Protocol No. is entered and the patient is listed as having consented, the Add Subject
to Protocol button appears.
12. Click the Add Subject to Protocol button.
You are transferred to the New Subject registration screen. On this page you can add a new
subject to the protocol. (We will not.)
13. Return to the Pre-Screening Search page via the Subjects Pre-Screening menu item.
Now that you've seen the Screening entry page, the initial search page makes sense. It's a
typical search page.
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Here you may enter or select data in the various fields to narrow your search. Let’s see the
pre-screening record you just entered.
Select your name in the Entered By field and click the Submit button.
The Search Results screen displays the search criteria in the header, and the found records in
a table below. The column headers in the table are hyperlinks – click them to sort the records
by that column.
14. Click on the Pre-Screening ID hyperlink. This will display the Pre-Screening Record. Click
the Update button.
Additional fields allow you to indicate who did the evaluation and the time it took, if the patient
is eligible. Once the patient goes On Study, the Patient On Study and Record Completed
fields may be set to Yes. You may enter additional information in the Subject Notes section
that will appear at the bottom of the page.
15. Click Submit to save the information, then click Close.
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Subject Calendars
OnCore Calendars and Calendar Activation
Your protocol has a calendar that defines a schedule of visits (when a subject is to be seen) and
what treatment will be done during each visit.
Because subjects accrue to the protocol at different times, the protocol schedule cannot contain
“hard” dates like “March 15”. Instead, schedules are based upon subject milestone dates like the
subject’s Consent Signed and On Study date. Offsets from these dates (e.g. “the tenth day after
the subject goes On Study”) are used to determine the “hard” date of a subject’s visit.
In the last session, you created a Subject and placed them on the protocol. When you entered a
number of subject milestone dates, you activated their calendar. OnCore has now generated a
personalized treatment schedule for the subject.
Viewing the Subject Calendar
To see the subject’s calendar, you need to go to the Calendar tab of the Subject Console.
1. If you are not on the Subject Console, navigate there via the Subjects  CRA Console or
Subjects  Subject Console menu item. Once you are viewing your subject in the Subject
Console, select the Calendar tab.
You should see something similar to this:
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In the first column, each row following “Visit Date” displays the name of a lab, panel, or
procedure.
The second column displays the names of the eCRFs (Forms) that will be used to capture data
from the corresponding lab, panel, or procedure.
The Planned Date row displays the subject’s scheduled visit dates. Hovering the mouse cursor
over the date in the Planned Date row will show which day of the week it is (and any visit
tolerances).
Below each visit date, an X indicates the labs, panels, and procedures scheduled for that date. If
the procedure is supposed to happen multiple times on a visit, there may be a number in front of
the indicator to show how many times it should happen, like 2X.
The Calendar tab has two horizontal tabs: Calendar and Orphaned Visits. The Calendar
horizontal tab is the default and is where the screenshot comes from. The Orphaned Visits
horizontal tab shows visits that were checked in on an older version of the subject’s calendar, but
aren’t on the subjects current version, perhaps because of a schedule change in the most recent
version.
Verifying Subject Visits – Visit Dates
The hyperlinks above each visit date (Screening, C1D1, etc.) are links to pages where you enter
visit information. This is called verifying the visit.
2. Select the Screening hyperlink.
The Subject Visit Update page is displayed. The first field on the page is the Visit Date, and the
data in this field defaults to the planned date shown on the calendar. You may change this date as
necessary.
The box next to the Visit Date shows the Visit Status. By default, the status is Planned, but not
yet Occurred.
3. Verify the visit by selecting the Occurred radio button. Click the Submit And Close button to
return to the Subject Calendar.
On the Subject Calendar the Visit Status shows Occurred and the Visit Date displays.
That was the simplest of Visit verifications. As you saw on the Subject Visits Update page, there
are a number of data entry fields to deal with Subject Visits.
4. Select the next visit hyperlink (C1D1).
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5. Verify the visit by selecting the Missed radio button. Click the Submit And Close button to
return to the Subject Calendar.
For missed visits, the Subject Calendar displays the Visit Status and Visit Date in red.
Take note of the visit dates for the missed visit and a few subsequent visits (C1D1 on 2/28/2013,
C1D15 on 3/14/2013, C2D1 on 3/28/2013, etc.).
6. Select the missed visit hyperlink (C1D1) again.
7. Click the Delete button and then click OK.
This has ‘undone’ or removed the visit information so we can go back and mark it as Occurred.
8. Select the C1D1 hyperlink.
9. Mark the visit as Occurred (which resets the date to the default).
10. Edit the Visit Date, changing it to two days later (3/2/2013).
11. In the Reset Calendar? field, select All Visits.
12. Click the Submit And Close button to return to the Subject Calendar.
The Subject Calendar shows the Visit Status as Occurred and displays the Visit Date you
supplied. Note that all subsequent dates have been reset to two days after their previous values.
13. Select the C1D15 visit hyperlink.
In the Visit Status area, note the N/A option. N/A is used to indicate that this visit does not apply
for this subject. Marking a visit as N/A will create a visit variation in the Financials Console.
14. Click the Submit and Close button.
Verifying Subject Visits – Visit Details
15. Select the C1D1 visit hyperlink again.
Most fields in the top half of the display collect details about the visit, and are self-explanatory.
The Submitted Date is the date the data has been submitted to the Sponsor. Entering a Locked
Date means no more changes should be performed on the data (this is not enforced – you can
change data on this page later). Collection Location is the location of correlative specimen
collection for this visit. Most often these additional date fields are used if you want to track data
entry done outside of OnCore.
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The Procedures table lists the labs, panels, and procedures that have been scheduled for the
Visit. (If Charge Master events have been linked to the lab/panel/procedure in the Financials
Console, they will also display).
Each procedure has a set of data entry fields:







Procedure Date - Enter a date only if it is different than the Visit Date above.
SOC - If the procedure is standard-of-care (as defined in the Financials portion of
OnCore), this will be pre-checked. Changing the state of this checkbox has Financial
implications. There is a security privilege that controls access to this checkbox.
SOC Modifier - Indicates whether the SOC procedure is Q1, Q0, or Unknown.
Missed - Check if procedure was missed during the visit.
Missed Count - You can have the calendar schedule a procedure to happen
multiple times during a visit. If some of those procedures were missed, indicate how
many.
N/A - Check if procedure was not applicable for this visit.
Location – If the procedure can be performed at different locations, this indicates
which location was used. This field is only available when the Cost Center
configuration is enabled.
Unless they are marked as Missed or N/A, it is assumed that if the visit has occurred, the
procedures have been performed on that Visit Date, unless otherwise indicated by the Procedure
Date.
Verifying Subject Visits – Additional Procedures
If a procedure is done during the visit that is not part of the calendar, the Additional Procedures
button can be used to record it. When the button is clicked, a popup window displays with multiple
horizontal tabs.
The Protocol Procedures tab lists the labs, panels, and procedures that have been assigned to
the protocol, along with their associated forms. Use the checkboxes and the Submit button to add
these events and forms to the visit record.
The All Charge Master Procedures/Labs tab lists all events in your protocol’s library. Use the
checkboxes and the Submit button to add one of these events to the visit record. No form will be
associated with these events.
The remaining tabs provide ways to search for and select events from the Charge Master or
create a new free-text procedure. Use checkboxes and the Submit button to add one of these
events to the visit record. Again, No form will be associated with these events.
16. Click the Additional Procedures button.
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17. Select the checkbox for the Physical Exam procedure, and click the Submit button.
18. In the popup box, enter a Reason for adding. Click the OK button to return to the Subject Visit
Update page.
The new procedure is listed in the bottom table.
If data has been recorded in a visit in error, the Delete button on the Subject Visit Update page
can be used to delete the visit. Visits with activated electronic case report forms (eCRFs) cannot
be deleted until the forms have been deleted.
19. Click the Submit And Close button to return to the Subject Calendar.
The calendar has a Summary button at the top. It is a way to shorten the number of visits
showing. This may be useful when there are a lot of visits and you would have to scroll to the right
to see the first unverified visits. When clicked, it will show the most recently verified visit and a
number of unverified visits. The total number of visits shown is a configuration setting. In summary
mode, there is a Full Calendar button that will return you to the full calendar view.
Additional Subject Visits
At times, subjects will be seen for visits that are not on the standard schedule. These visits can be
recorded via the Additional Visits vertical tab. Clicking the New button on the Additional Visits
tab displays a Subject Visit Update page where visit details can be entered.
Once a Visit Date is entered and the Submit button clicked, an Additional Procedures button
displays at the bottom of the page. Only procedures selected from the Protocol Procedures tab
have the ability to have Forms associated with them. When the forms are displayed on the Forms
by Status  To Do Forms tab, the visit will be named ‘Additional’.
Additional visits do not appear on the subject calendar.
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Subject Search
Subject Search is a robust searching tool. You specify the search criteria and which subject data
to display in the search results. Search results may be exported to a PDF report or Excel
spreadsheet. (It is structured in the same way as Protocol Search, which was discussed earlier in
this course).
1. Open the Subject Search page via the Subjects > Subject Search menu item.
The Subject Search page provides dozens of data fields. To search, enter data into fields to
indicate which subject data you wish to match, then click the Search button. You may enter as
many data items as you wish.
2. Type intials in the Last Name field in the upper section, then click the Search button.
The top of the results page lists the criteria used in the search.
If your search returns a large list of results, there are navigational aids to display the next (and
previous) page of results, jump to a particular page, or filter the matching data (text entered
into the Filter: field will limit the found results to those having the text in any of their columns).
Below is a table of matching subjects, each subject listed in its own row. Column headers are
hyperlinks, and selecting them will cause the results to be sorted by that column’s data
(selecting a column again sorts the data in ‘reverse’ direction).
Subject MRN column values are hyperlinks. Selecting the link will display the subject in the
Subject Console.
The bottom of the results page reports a count of the number of subjects found.
The View Excel button creates an Excel spreadsheet with the search result data. The View
PDF button creates a PDF document with the search results.
New Subject Staff can be added to selected subjects using the Add Staff button.
3. Return to the Subject Search page by selecting the Back to Search button.
Note that the criteria used in the last subject search are automatically filled in. The Clear
button is provided to remove any previously-selected items.
4. Click the Clear button to remove the data you previously entered.
The Subject Search page is divided into expandable sections. Each section has a header with a
[+] hyperlink and a section name. To open a section, click its [+] hyperlink.
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5. Click the [+] hyperlink to open the On Study section.
More search criteria fields are displayed. On the left are Result Column checkboxes. These
may be selected to include additional data columns on the search result page.
6. Click the Race checkbox in the upper section.
In the On Study section, enter an On Study Date range of 01/01/2012 to 12/31/2013.
In the On Study section, click the Result Column? checkbox for On Study Date.
The checkboxes allow you to customize the data that appears in the search results.
Click the Search button.
In the Subject Search Results page, the header indicates that this is a list of subjects that went
On Study in 2012. In the table of results, a column for the On Study Date is now included.
7. Use the Back to Search button to return to the Subject Search page.
Subject Search criteria can be saved so you can access this information more quickly. After
you have developed and tested search criteria that you like and will use over and over, you
can save the search to avoid remembering and entering all of the criteria again. (Dates that
you enter are saved as the calendar date, however, and are not saved as a relative date.
Entries like ‘YB’, are not re-evaluated each time the saved search is picked).
8. Click the Save As button (found at the top of the page).
9. Enter a name for your search in the Name field and click the Save button.
Your saved searches will be available in the Saved Searches drop-down field at the top of the
page. They will also display in the Saved Searches widget on the Home page.
My Console
My Console is designed to assist subject staff in managing subject visits. It provides a means to view
and verify visits without having to access each subject individually from the CRA Console and
Subject Console.
My Console provides a personalized view of OnCore data, displaying information that is relevant to
the current OnCore user.
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1. Open My Console by selecting the My Console  My Console menu item.
The My Console page has four vertical tabs. The Protocols tab displays all protocols to which
you have been assigned as part of the Protocol Staff, regardless of Role. (Protocol Staff are
defined on the PC Console  Main  Management tab). A protocol must have an Active
status of Open to Accrual, Closed to Accrual, or Suspended to appear in My Console.
Protocols that have been Terminated or had an IRB Study Closure will not be displayed.
Each protocol displayed has a hyperlink for its protocol number. Clicking the hyperlink will
launch the PC Console.
2. Click the Subjects tab.
The Subjects tab displays all subjects to which the user has been assigned as part of the
Subject Staff. (Subject Staff are defined on the Subject Console  On Study tab).
Initially, active subjects on active protocols are shown, but this can be changed using the filter
controls in the header band. Unchecking the 'Show Active Protocols Only' checkbox will cause
subjects from all protocols to show. Selecting a different Subject Status from the dropdown will
cause subjects of different statuses to show. The available choices map to these Subject
Statuses:


Active: Consented, Eligible, Eligible(O), On Study, On Treatment, Consent Waived
On Follow Up: Off Treatment, On Follow Up
Subjects are shown in a table with hyperlinked column headers. Clicking a column hyperlink
will sort the table based upon data in that column.
Each subject displayed has a hyperlink for its Subject MRN. Clicking the hyperlink will launch
the Subject Console.
3. Click the Subject Visits tab.
The Subject Visits tab contains two horizontal tabs to view Occurred Visits and Pending
Visits for your subjects. This tab is the most functional, as it provides a way for you to quickly
update information regarding subject visits without the having to navigate to each subject visit
individually.
On the Occurred Visits tab, you can see if the forms for each visit were completed, submitted
and monitored on any given day. (These columns correspond to the visit’s Data Collection
Completed Date, Submitted Date, and Monitored Date fields from the Subject Visit Update
page). The list is useful for keeping track of your eCRF load for externally sponsored trials
Subject Search and Additional Consoles │ 3 of 7
where you need to complete case report forms and send them to the sponsor or have the
sponsor monitor them.
You may update the dates for these visits by selecting each checkbox that applies, completing
the date field at the bottom of the column, and clicking the Submit button. When the CRF
Completed date is filled in and either the CRF Submitted date or the CRF Monitored date is
also filled in, the visit will no longer show in the list because you are finished with its work.
4. Click the Pending Visits horizontal tab.
On the Pending Visits tab, you can view all non-occurred visits within a given timeframe. The
From Date defaults to a week prior to the current day and the Thru Date default to a week
after the current day. This quickly gives you a view of any recent visits that you still need to
verify, and some upcoming visits you may need to plan for.
Subject visits may also be filtered by a particular protocol or a particular subject by selecting
values in the Protocol Filter and Subject Filter Find-As-You-Type fields. (If a protocol is
selected in the Protocol Filter, the Subject Filter will only supply subjects assigned to the
selected protocol).
5. Enter a From Date of 05/01/2013 and click the Refresh button.
Each Pending Visit has a hyperlink in the Visit column. Clicking this hyperlink takes you to the
Subject Visit Update page, where you may enter details about the visit. The Planned Visit
Date is the Visit Date in the subject’s calendar. If you don’t have extra details to record for a
visit, you may mark it as Occurred by completing the Actual Visit Date field and clicking the
Submit button. You may mark a visit as Missed by checking its checkbox and clicking the
Submit button. Multiple visits may be verified simultaneously in this way. Future visits cannot
be marked as Missed.
The Clinical Comments field is a read-only field displaying the Clinical Comments from the
Subject Visit Update page.
6. Click the My Calendar tab.
The My Calendar tab displays your subject visits in a month format calendar. Initially it shows
visits for subjects you are assigned to as Subject Staff and visits for subjects on protocols
you’re assigned to as Protocol Staff. There are checkboxes at the bottom of the calendar that
can be used to change these visit filters.
You may change the calendar view by using the icons below the month title at the top. The
view can be changed to a single day, one week, or one month. You can click on the month and
Subject Search and Additional Consoles │ 4 of 7
year titles at the top of the calendar to quickly select another month and year, or navigate one
day, week, or month at a time using the dates to the right and left in the header area.
On the calendar, the subject name, protocol number, and visit description are hyperlinks
that will jump you to the Subject Console, PC Console, and Subject Visit Update page,
respectively.
Team Console
The Team Console is a progress reporting and protocol management tool used by a management
team. A staff member with a Management Group in their staff record will see data for all protocols
assigned to the Management Group.
Team Console provides a personalized view of OnCore data, displaying information that is relevant to
the current OnCore user.
1. Open the Team Console by selecting the Reviews  Team Console menu item.
When you pull up the Team Console, a Management Group dropdown is displayed at the
bottom of the left column. All of your Management Groups are available. (Your Management
Groups are defined in your Staff record.) Choosing a different group updates the display. Data
displayed by the Team Console is relevant to the currently selected Management Group.
(If your account does not have at least one Management Group, you do not have the capability
to use the console as it is meant to be used.)
The Pending Protocols tab displays the selected Management Group's protocols that have
yet to be Opened to Accrual. You can see where each protocol is in the approval process and
can check basic information about the protocol such as number and title, the principal
investigator, and see the committee approvals, signoffs, and checklist items.
The Protocol No displays as a hyperlink. Selecting the hyperlink transfers you to the PC
Console. Each protocol also displays a Checklists hyperlink, which transfers you to the
Protocol Checklists page.
2. Click the Open Protocols tab.
The Open Protocols tab displays the selected Management Group's protocols that are open
to accrual. The open date, summary accrual information, and accrual information for the last
four months are shown.
The five other tabs require the Last Meeting Date to be entered so you can review information
that has been entered since the last meeting.
Subject Search and Additional Consoles │ 5 of 7
3. Enter 01/01/2010 in the Last Meeting Date field.
4. Click the Closed Protocols tab.
The Closed Protocols tab displays the selected Management Group's protocols that have
been Closed to Accrual since the Last Meeting Date.
5. Click the SAEs tab.
The SAEs tab displays the selected Management Group's SAEs that have had an Event Date
or Reported Date since the Last Meeting Date. SAE information is displayed, and an SAE
hyperlink is supplied for quick access to the SAE page.
6. Click the Deviations tab.
The Deviations tab displays the selected Management Group's Deviations that have a
Reported Date or Deviation Date since the Last Meeting Date. The protocol and deviation can
be viewed quickly with the hyperlinks provided.
7. Click the OSRs tab.
The OSRs tab displays the selected Management Group's Outside Safety Reports that have
an Issued Date or Received Date since the Last Meeting Date. It shows information about the
OSR and has a hyperlink to jump to the protocol.
8. Click the Summary tab.
The Summary tab shows overall counts of protocols in various statuses along with counts of
deviations, OSRs, SAEs and registrations for the selected Management Group.
DSMC Console
The DSMC Console is intended to assist Data Safety Monitoring Committee (DSMC) reviewers when
reviewing protocols. It consolidates and displays captured data, and provides a means to export this
data for use by products like Microsoft Word. It is a very useful (and unique) view of a protocol’s
information.
9. Open the DSMC Console by selecting the Reviews  DSMC Console menu item.
10. Select your protocol in the Select Protocol Find-As-You-Type field.
Your protocol will load into the console and its information will be displayed. On the left, vertical
tabs can be clicked to present various protocol information. Some of these tabs present
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information that is only available here, like the Accrual History, Disposition, Baseline
Demographics, Response, and Survival/TTP tabs.
The Export tab allows you to select which tab information you would like to export to a Rich
Text Format (RTF) document that can be opened in Microsoft Word.
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Reporting and Searching
Protocol Search
Protocol Search is a robust searching tool. You specify the search criteria and which protocol
data to display in the search results. Search results can be exported to a PDF report or Excel
spreadsheet.
11. Open the Protocol Search page via the Protocols > Protocol Search menu item.
The Protocol Search page provides dozens of data fields. To search, you enter data into fields
to indicate which protocol data you wish to match, then click the Search button. You may enter
as many data items as you wish.
12. Click the Completed checkbox in the top Protocol Status section, then click the Search
button.
The Completed, Active, Pending checkboxes look at the current status of the protocol. Here
are the protocol statuses that fit into each category:



Pending: New, PRMS Approval, IRB Initial Approval, On Hold, and all Protocol Signoffs.
Active: Open to Accrual, Suspended, and Closed to Accrual.
Completed: Abandoned, Terminated, and IRB Study Closure.
The top of the results page lists the criteria used in the search.
If there are a great deal of matching protocols, navigational aids are provided to display the
next (and previous) page of results, jump to a particular page, or filter the matching data (text
entered into the Filter: field will limit the found results to those having the text in any of their
columns).
Below this is a table of matching protocols, each protocol listed in its own row. Column
headers are hyperlinks, and selecting them will cause the results to be sorted by that column’s
data (selecting a column again sorts the data in ‘reverse’ direction).
Protocol No. column values are hyperlinks. Selecting the link will take you to that protocol in
the PC Console.
The bottom of the results page reports a count of the number of protocols found.
The View Excel button creates an Excel spreadsheet with the search result data. The View
PDF button creates a PDF document with the search results.
Reports and Searches │ 1 of 7
The Add Staff button allows you to add staff to all protocols with Add Staff? checkbox
selected. After clicking this button, a pop-up window appears with find-as-you-type fields for
Staff Name and Staff Role. You can also set the Start Date for the Protocol Staff.
13. Click the Back to Search button to return to the Protocol Search page.
Note that the criteria used in the last protocol search are automatically filled in. The Clear
button is provided to remove any previously-selected items.
14. Click the Clear button.
The Protocol Search page is divided into expandable sections. Each section has a header with a
[+] hyperlink and a section name. To open a section, click its [+] hyperlink.
15. Click the [+] hyperlink to open the Main section.
More search criteria fields are displayed. You should see a list of fields related to the Main tav
of the PC Console.
On the left are Result Column checkboxes. These may be selected to include additional data
columns on the search result page.
16. Click the Completed checkbox in the top Protocol Status section.
In the Main section, click in the Phase field to display a list of choices. Choose Phase II
studies.
Clicking in the field again will allow you to select another choice, expanding your search.
In the Main section, click the Result Column? checkbox for Protocol Type.
Click the Search button.
In the Protocol Search Results page, the header indicates that this is a list of Phase II
protocols that are Completed (Abandoned, Terminated, or IRB Study Closure). In the table of
results, a column for the Protocol Type is now included.
17. Click the Back to Search button to return to the Protocol Search page.
Some search criteria can be a bit more complex. At the top of the page is the Status field. To
use this field, you must specify a status and date criteria. If you provide a From Date and a
Thru Date, you are indicating that you wish to see protocols that had that status at any time
during the date range. Supplying only a From Date matches protocols having that status at any
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time after the From Date, while supplying only a Thru Date matches protocols having that
status at any time prior to the Thru Date.
18. In the Status field, select Open To Accrual.
In the corresponding From Date, enter 01/01/2013.
In the corresponding Thru Date, enter 12/31/2013.
(It is assumed that the previous search criteria are still in place.)
Click the Search button.
Your previous results have now been narrowed to those Phase II protocols that were Open To
Accrual at some point in 2013 and are currently marked as Completed.
19. Return to the Protocol Search page.
Similar to the Status field, there is a Status Change field at the top of the Protocol Search
page. When this field is used, the search returns protocols that had their status changed to the
selected status at some point during the date range.
The second to last section of Protocol Search is labeled Accrual. It includes checkboxes to
display the protocol accrual grouped by all affiliates, the research center, and the VA. The
section has From Date and Thru Date fields for limiting the accrual period (otherwise, the
lifetime protocol accrual is shown). These dates can be used by themselves or in conjunction
with the Status and Status Change date ranges.
Protocol Search criteria can be saved and saved searches can be found and run quickly. After
you have developed and tested search criteria that you like and will use over and over, you
can save the search to avoid remembering and entering all of the criteria again. (Dates that
you enter are saved as the calendar date, however, and are not saved as a relative date.
Entries like ‘YB’, are not re-evaluated each time the saved search is picked).
20. Click the Save As… button (found at the top of the page).
21. Enter a name for your search in the Name field and click the Save button.
Your saved searches will be available in the Saved Searches drop-down field at the top of the
page. They will also display in the Saved Searches widget on the Home page.
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Document Search
Document Search lists documents associated with protocols. Documents include those attached
via the PC Console > Documents/Info > Attachments tab. Also listed are released documents
attached to IRB reviews.
22. Open the Document Search page via the Protocols > Document Search menu item.
The Document Search page provides a number of search criteria fields. Use the fields to
describe the protocols you wish to match. Only active protocols (those having a status of Open
to Accrual, Closed to Accrual, or Suspended) matching the criteria will have their associated
documents listed.

Protocol No. – A find-as-you-type field to select a particular protocol.

Keyword – Text entered here will look for matches in the Title, Short Title, or Objective
fields of protocols (PC Console > Main > Details tab).

Investigator - Matches protocols with the specified Investigator (PC Console > Main >
Staff tab, Protocol Staff section).

Institution - Matches protocols having the specified Institution as a Participating Institution.
This field is required and will default to the institution with which your user record is
associated. You will only be able to select institutions to which you have access.
A protocol may have multiple versions of a document. By default, the latest version of a
document is displayed in the search results. When the Display All Documents box is
checked, matching protocols will list ALL versions of their protocol documents. This is a
configuration option and may or may not be present in your system.
23. Enter the text tumor into the Keyword field and click the Submit button.
Only protocols with associated documents will display. Search results are sorted by protocol
number. The Alt. Protocol No. column displays the protocol’s IRB, PRMS, and Sponsor
Protocol numbers.
Each document is listed by document type and hyperlinked File Name. When a consent
attachment is a combined consent, the search results display text that describes the original
document. The original document will appear as a hyperlink.
The Version Date column may also show the document expiration date in red font, depending
upon your system configuration.
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Reports
OnCore has many standard reports. We’ll review a few of them and leave the rest to you as a selflearning exercise. Reports are documented in the product overview documentation.
Planned Visits Report
The Planned Visits Report shows a list of subject visits for a date range and can be filtered by
Protocol, Procedure, Subject Staff, Organizational Unit, and Management Group. It is available via
the Reports > Reports menu item in the Planned Visits section.
24. Open the Planned Visits Report criteria page via the Reports > Reports menu item. Use
the vertical tab to display the Planned Visits report group.
25. Enter the following criteria and click the Submit button.




Visit Date From: 01/01/2011
Visit Date Thru: 12/31/2011
Protocol No: CAR-001
Organizational Unit: Health Affairs
The results display all visits for the protocol during the date range. The hyperlink in the Visit Info
column will take you to the Subject Visit Update page where you can verify the visit and enter visit
information.
Oncology Reports
OnCore has several reports that are specific to the oncology area of clinical trials. These reports
are available via the Reports > Reports menu item in the Accrual Monitoring – Oncology Only
section. There are a number of Data Table 3 and Data Table 4 reports.
In addition, there are related discrepancy reports used to assist in assuring that your Data Table 3
and Data Table 4 reporting is accurate. The Discrepancy reports point out protocols and subjects
that have data to may need to be fixed in order for them to be included in Data Table 3 and Data
Table 4 reporting. We recommend that the discrepancy reports be run periodically to find and fix
inaccurate or incomplete data.
Accrual Monitoring Console
The Accrual Monitoring Console provides a quick means to view protocol accrual information
categorized by Oncology Group or Department, Management Group, Principal Investigator, or
Subject Staff.
How To Use the Console
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26. Open the console via the Reports  Accrual Monitoring menu item.
The top of the page contains two date entry fields. Both of these must be filled in to use the
Console.
Along the left side are the four different categories: Department, Management Group, Principal
Investigator, and Subject Staff. Each category contains a hyperlink tab and/or a
Find-As-You-Type data entry field. After the dates have been entered at the top, clicking a tab
or selecting an entry will launch a search.
The search results are displayed in the main area to the right.
27. Enter a From Date of 01/01/2013 and a Thru Date of 12/31/2013.
These dates indicate that you are looking for accruals that have occurred during the 2013
calendar year.
28. Click the By Scope tab in the Management Group section.
A search is done for all protocols that were open to accrual in the date range. The results list
the number of protocols and number of accruals during that range. Data is categorized by the
scope (defined in the PC Console  Main  Details tab), and then further divided for each
Management Group.
29. Select the By Sponsor Type tab in the Management Group section.
Again, a search is done for all protocols and accruals in the date range. This time, the results
are categorized by the type of principal sponsor (defined in the PC Console  Main 
Sponsor tab), and then further divided for each Management Group.
30. In the Protocol Accrual For Find-As-You-Type field in the Management Group section,
select Med-Geriatrics.
A search is done for all protocols that were open to accrual in the date range and have the
selected Management Group chosen in the PC Console  Main  Management tab.
In this case, individual protocols are listed, and have some accrual information displayed:


The Summary Accrual section displays the accrual counts for this protocol during the
entire time the protocol has been open up to the time the report is run (not just for the date
range entered).
The Period Summary Accrual section displays the accrual counts for this protocol during
the date range entered.
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
The Period Accrual section also displays the accrual counts by month during the selected
time period. (Those protocols marked as Summary Accrual Info Only in PC Console 
Main  Details will not have accrual counts displayed in the this section since the accruals
are entered over a variable timeframe.)
Additional Information about Searching
When searching by Management Group, a protocol will only be counted according to its primary
Management Group.
Checking the Therapeutic Protocols Only checkbox in the upper section will reduce the resulting
protocols to only those with a Protocol Type (PC Console  Main  Details  Protocol Type)
where the parent type is defined as Therapeutic in the Reference Codes.
When changing the date range or the Therapeutic Protocols Only checkbox, the Refresh button
must be clicked to perform a new search.
Exporting the Search Results
The View Excel button creates an Excel spreadsheet with the search result data.
The View PDF button creates a PDF document with the search results.
The View Chart button displays a bar chart with the results. (Because of the different
configurations of search results, a bar chart is not always available.)
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