Entering Regulatory
Information, Updating
Protocol Status and Patient
Accrual in OnCore (13.0 V2)
For questions regarding information in this document, please contact OnCore support:
oncorecc@iupui.edu
1|Page
Version Date: 13-Feb-2015
Table of Contents
1. Basic Navigation ........................................................................................................................................ 3
1.1 Entering Regulatory Information ........................................................................................................ 3
1.2 Assigned Studies ................................................................................................................................. 4
1.3 Updating Protocol Staff....................................................................................................................... 5
2. Updating Protocol Status: Cancer Center ................................................................................................. 7
2.1 IRB Initial Approval.............................................................................................................................. 7
2.2 Updating Status: open to accrual, closed to accrual, and protocol termination .............................. 10
2.3 Updating Protocol Status: Additional Institutions ............................................................................ 12
3. Updating IRB Decisions and Uploading Required Documents ................................................................ 13
3.1 Entering Amendments, Continuing Reviews, and other IRB decisions............................................. 13
3.1.1 Adding New Documents to an IRB Review ............................................................................... 14
3.1.2 Adding Previously Uploaded Documents to an IRB Review...................................................... 15
3.2 Uploading Consent Forms ................................................................................................................. 16
3.3 Entering Re-Consents ........................................................................................................................ 17
4. Updating Patient Accrual ........................................................................................................................ 18
4.1 Summary Accrual Only ...................................................................................................................... 18
4.2 Registering Patients Individually ....................................................................................................... 21
5. Entering Subject Deviations .................................................................................................................... 24
6. Entering Serious Adverse Events (SAEs) .................................................................................................. 26
6.1 SAE entry for Interventional Trials .................................................................................................... 26
6.2 SAEs for Summary Accrual Only Trials .............................................................................................. 29
2|Page
Version Date: 13-Feb-2015
1. Basic Navigation
1.1 Entering Regulatory Information
PC Console
The PC Console is the area within OnCore to document and view relevant information about a protocol
such as
 protocol title, status, staff, objectives, sponsor, disease site, and participating institutions
 Protocol related IRB activity such as: initial approval, amendments, and continuing reviews
 Protocol related documents such as: IRB approved protocol document, IRB approved
amendment(s), informed consent document, and the IRB approval document (DRA)
Protocols > PC Console

From the OnCore home screen, the PC can be accessed from the dropdown menu of the
“Protocols” tab
3|Page
Version Date: 13-Feb-2015
1.2 Assigned Studies
The assigned protocol coordinator is responsible for updating all required reporting information for that
protocol. To view a list of studies on which you are designated as the protocol coordinator, you will
need to use the protocol search function
Protocols > Protocol Search

The protocol search can be accessed from the Protocols tab on the home screen
Protocols > Protocol Search



Type your name [last, first] into the staff name search box and click to select yourself
Type [Protocol Coordinator] into the Staff Role box and select the Protocol Coordinator Role
Hit Enter or click the [search] button to complete your search
4|Page
Version Date: 13-Feb-2015
1.3 Updating Protocol Staff
If you find that you are listed as a protocol coordinator on a protocol that you are no longer working on,
you will need to update the study staff in OnCore to reflect the current study staff. Study staff is
updated through the horizontal Staff tab of the PC Console
PC Console > Main > Staff: Update


Access the staff tab in the main section of the PC Console
Click [update]
5|Page
Version Date: 13-Feb-2015
PC Console > Main > Staff: Update

To add a new protocol coordinator or staff member fill out the following fields
Role
Staff Name
Start Date



Select the study role for the staff member you are trying to add, if you want to
add a new Protocol Coordinator, select “Protocol Coordinator”
Select the name of the staff member you want to add to the study (**note**
you can only add staff members who are registered in OnCore. Contact an
OnCore Administrator to have additional staff added to OnCore as needed)
Fill out the date for which the staff member became active on the protocol
If a staff member discontinues work with the protocol, or if a study is transitioned to a new staff
member, you should enter a stop date for any staff who are no longer associated with the
protocol
To enter a stop date, click the [edit] hyperlink to the right of a staff member’s name.
Enter a stop date and a reason (i.e. “staff left” or “study transition”)**
**Note** If a large number of studies are being transitioned from one staff member to another, contact
your OnCore Administrator for assistance. They can transition all studies from one staff member to
another through a much more efficient process.
6|Page
Version Date: 13-Feb-2015
2. Updating Protocol Status: Cancer Center
In order to comply with reporting requirements, the status of each protocol must be kept current.
There are 5 Statuses that must be reviewed and updated (when necessary) in OnCore on no less than a
monthly basis:





IRB Initial Approval
Account Sign Off
Open to Accrual
Closed to Accrual
Terminated
2.1 IRB Initial Approval
Once a Protocol becomes IRB approved, the following steps (1-2) must be completed for the Protocol
Status to read “IRB Initial Approval”. Once you have completed these steps you will be able to add your
IRB No (step 3).
Step 1
Protocols > PC Console > Reviews > IRB

IRB Review decisions and communications are recorded in the Reviews page of the PC Console.
From the Reviews page of the PC Console, select the IRB horizontal tab. Use the [Add] button to
open the IRB page and enter a new record.
7|Page
Version Date: 13-Feb-2015
Step 2
Protocols > PC Console > Reviews > IRB, [Add] button:



IRB review information should be updated on a monthly basis.
Review information should be completed given what is applicable at the time. If a review has
been submitted to IRB but no action has been returned before the monthly reporting deadline,
the only fields that MUST be completed are: submit date, review reason, and summary.
Approval information can be updated when approval is received.
Press [Create] to submit. This will change the protocol status to “IRB Initial Approval.”
Review Date
Action
Action Date
Expiration Date
Date of IRB review. This must be selected from the dropdown list of IRB meeting
dates. (this date is found on the IRB approval document)
Date sent to IRB. If unknown, Action Date may be used.
IRB committee that processed the review. This information is found on the IRB
approval document.
Choose review reason. To set the protocol status to “IRB Initial Approval” select
Initial Review.
Choose “expedited” or “full” from the dropdown menu. This information can be
found on the IRB approval document.
Choose the action returned from the IRB.
Enter Date of IRB approval once approval has been received.
Enter the expiration date as found on the IRB approval document.
Review Number
Only needs to be entered for amendments.
Institutions*
Add additional Institutions utilized for the study that are using the same IRB
approval (i.e. VA, Wishard, etc.…).
Submit Date
Committee
Review Reason
Review Type
*NOTE: These can only be added if they are already listed on the Institutions page (usually done at SRC
Submission) and the “Uses Research Center IRB” box is checked.
8|Page
Version Date: 13-Feb-2015
Protocols > PC Console, Console Header:

The Protocol Status in the PC console header now reads “IRB Initial Approval.”
Step 3
IRB numbers are entered through the horizontal management tab in the main section of the PC Console.
Protocols > PC Console, Main, Management:

To enter a study IRB No., select the ‘Management’ tab located on the Main page. Hit the
[Update] button at the bottom of the page and fill in the IRB No. field. Click [Submit] to save.
9|Page
Version Date: 13-Feb-2015
2.2 Updating Status: open to accrual, closed to accrual, and protocol
termination
After IRB approval, additional statuses will need to be reviewed monthly and updated as needed.
Additional protocol status changes are made from the Status tab.
Protocols > PC Console > Status

Protocol status is updated by pressing the appropriate status button at the bottom of the page
(i.e. “open to accrual, closed to accrual, terminate)

The following fields are available for entry
Status Date
Initiator
Change Reason
Comments
Last Changed By
Date of protocol status change (i.e. date the protocol became open to
accrual, closed to accrual, terminated, etc.). This field is mandatory and must
be completed for all status updates.
Party who requested or required the status action. Should be completed
where applicable. Options are chosen from the provided dropdown list.
Reason why the status was updated. Should be completed where applicable.
This field is required for the closed to accrual status and recommended at
other time points.
Enter additional important information in this field.
This field is auto-populated from the user who completed the status update.
The following protocol statuses will be displayed on the Status page:
o
The [Account Signoff] button is available after IRB Initial Approval has been entered.
You can enter the IRB Approval date for this if it is unknown.
o The [Open] button becomes available after IRB Initial Approval and Account Signoff has
been completed. Enter the date you can start enrolling patients.
10 | P a g e
Version Date: 13-Feb-2015
o The [Close To Accrual] button is available after Open to Accrual. Enter the date you can
no longer enroll patients on the trial. Initiator and change reason should always be
completed for this status change.
o
The [IRB Study Closure] option is available after the study is marked as closed to
accrual; however this status is not required for reporting and should never be selected
in place of study termination.
o
The [Terminate] button is available after the protocol is Closed to Accrual and indicates
no further action is required. The reason for study termination MUST be selected from
the search box (see screenshot below).
Protocols > PC Console > Status, [Terminate]
11 | P a g e
Version Date: 13-Feb-2015
2.3 Updating Protocol Status: Additional Institutions
Protocol statuses for additional participating Institutions must be updated on a monthly basis. This is
done via the Institutions page of the PC Console.
Protocols > PC Console > Institution:

Choose a participating Institution by clicking on the blue hyperlinked institution name and select
the Status tab.
Protocols > PC Console > Institution > [Institution Hyperlink] > Status

Update Status and Status Date. Hitting the [Add] button will result in the Protocol Status
updating for the participating Institution.
12 | P a g e
Version Date: 13-Feb-2015
3. Updating IRB Decisions and Uploading Required Documents
3.1 Entering Amendments, Continuing Reviews, and other IRB decisions
Protocol amendments, continuing reviews, and other IRB decisions must be recorded and uploaded
through the IRB reviews tab
PC Console > Reviews > IRB > Add

To add an new IRB review, click the [Add] button
The Details section of the Update IRB page is used to add information about all IRB documents that were
submitted with a given IRB review including Amendments, Consents, Protocol, Continuing Review
Documents, and IRB Approval Documents. New documents can be added using the [Add] button, while
previously uploaded documents can easily be copied from older reviews using the [Select Previous
Details/Docs] button.
PC Console > Reviews > [New] or Edit > Details > Add:
13 | P a g e
Version Date: 13-Feb-2015
3.1.1 Adding New Documents to an IRB Review
PC Console > Reviews > [New] or Edit > Details > Add:

Enter the relevant information as follows
Amendment No.
Type
Received Date
Version Date
Description
Global? checkbox

Only enter if your review is an Amendment.
Choose Document Type from the dropdown menu (i.e. consent, amendment,
continuing review, etc.). If the document type is not listed in the dropdown options,
“Other” can be chosen and a description of the document can be entered in the
“description” section
This can be left blank (this is used to record the date a document was received from
a sponsor)
Enter Version Date of document.
You may add a description of the document here
Check this box if this version is used at multiple performance sites (satellite site
using the same IRB such as IU utilizing Wishard and the VA).
Press Save. Repeat these steps to add details for all applicable documents.
14 | P a g e
Version Date: 13-Feb-2015
PC Console > Reviews > [New] or Edit > Details > Attach a File:




Once a detail has been saved, the option to attach a file or URL appears beneath the newly
added detail
Click on the blue [File] hyperlink and then click the [Browse] button to choose a file to upload
from your computer. Click [Submit] to save.
All documents that were submitted with a given IRB review should be uploaded in this section
Documents uploaded with an IRB review are linked to the expiration date of that review. As
such, these documents will expire on the set expiration date.
3.1.2 Adding Previously Uploaded Documents to an IRB Review
Some documents do not expire, such as the protocol or the Investigator Brochure. These documents, if
associated with the new review can be selected from the previously uploaded documents using the
[Select Previous Details/Docs] button.
15 | P a g e
Version Date: 13-Feb-2015
3.2 Uploading Consent Forms
Consent forms are uploaded to OnCore through a separate process than other protocol specific
documents.



Consent information must be added to the details section of IRB reviews tab before they can be
uploaded to OnCore (see section 3.1 for instructions on entering IRB review details)
IRB approved informed consent documents are attached and uploaded through the consent
forms tab of each individual institution
A separate consent must be uploaded to each institution listed on the Protocol
PC Console > Institution > Institution Hyperlink [Indiana University]


Navigate to the Institutions tab within the PC Console
Click the blue hyperlinked institution name to open that institution (*note in this example the
institution is “Indiana University” however the same instructions apply for all institutions)
16 | P a g e
Version Date: 13-Feb-2015
The treatment consent details entered in the IRB reviews record are pulled through and the version date
and approved date will display in the Consent forms tab. The treatment consent document can be
attached and removed here.
PC Console > Institution > Institution Hyperlink [Indiana University] > Consent Forms

To add a consent form, select [Browse] and select the appropriate document from your files.
Select [Add] to attach the form.
3.3 Entering Re-Consents
During the life of a protocol, consent forms may be modified. In these instances, subjects may be
required to sign the amended consent form. OnCore provides a Re-consent Required checkbox to flag
subjects that are required to sign the amended consent form.
IRB Reviews Page, Reconsent:

When an amended consent form is added to the IRB Reviews, a Reconsent Required? Checkbox
appears in the Details section. If subjects are required to sign the new consent form, check this
box.
The IRB Actions page will display the amended consent record.
PC Console > Reviews > IRB:
17 | P a g e
Version Date: 13-Feb-2015
The superscript RR indicates re-consenting is required. Subjects with the following statuses will be
marked with the superscript RR on the CRA Console
4. Updating Patient Accrual
Patient accrual can be updated two ways
1. Summary accrual only: Protocols defined as being health services research, basic science,
and other (i.e. banking, ancillary/correlative, retrospective chart review, registry,
epidemiologic/outcomes, etc.) can participate in summary accrual only reporting**
**Note: If a trial is collecting data on individual patients using OnCore as an electronic
data capture system, this trial cannot participate in summary accrual only reporting
regardless of trial type.
2. Registration of individual patients: Protocols defined as treatment, prevention, supportive
care, diagnostic, or screening MUST register each individual patient to their protocol (follow
the steps for Individual Patient Registration below)
4.1 Summary Accrual Only
The details section of the PC Console will give you information about your protocol type.
18 | P a g e
Version Date: 13-Feb-2015
Protocols > PC Console > Main > Details:

The “Protocol Type” section identifies the protocol category

If a protocol falls into any of the protocol type categories for which summary accrual is allowed
and individual patients will not be registered in OnCore, the Summary Accrual Info. Only box
should be marked ‘Yes’.
19 | P a g e
Version Date: 13-Feb-2015
If a protocol is marked “Yes” for Summary Accrual Info Only, the protocol accrual will be updated
through the Accrual tab of the PC Console
Protocol > PC Console > Accrual (If Summary Accrual Info = Yes)
 The following information must be entered quarterly if accrual occurs:
From Date
Must be the first day of the quarter.
Thru Date
Must be the last day of the quarter.
Accrual
Number of patients of a selected gender, race, and ethnicity placed on
study during the timeframe listed.
Institution
Select institution at which patients were accrued from the dropdown
menu**
Institution Type
Choose from Research Center (If the institution is the main site), VA or
Affiliate (i.e. Wishard, Methodist, Vanderbilt, etc…)
Gender
Choose from dropdown
Race
Choose from dropdown
Ethnicity
Choose from dropdown
*End of year reporting must be completed by January 15 of the following year

Click [Add] to submit the accrual information

The Copy hyperlink will create a duplicate entry and allows you to quickly enter multiple
lines of data with minor changes.

The Edit hyperlink allows editing of the original line of data.

Multiple line items may need to be added each quarter based on the population enrolled
in the study.
20 | P a g e
Version Date: 13-Feb-2015
4.2 Registering Patients Individually
If you have identified that your protocol will need to register patients individually, you will need to enter
your accrual information through the CRA Console.
Subjects > CRA Console

Click on the “New Subject Registration” tab to register a new patient to the selected protocol
21 | P a g e
Version Date: 13-Feb-2015
Subjects > CRA Console > New Subject Registration

Complete all 5 fields under the Find Fields section and hit [Find]. This will allow OnCore to
search the OnCore and IU hospital system for demographic information. A list should result at
the bottom of the page so you can choose your patient.

If the subject is not found in the resulting list, enter the following fields manually under the New
Subject Details section and click [Add].
Study Site
Select study site where the subject will be treated. If your study site is not
listed, please contact the OnCore Administrator.
Subject MRN
Last Name
Birth Date
Enter a unique MRN for the subject.
Enter the subject’s last name.
Enter the subject’s date of birth in MM/DD/YYYY format. Check the “Not
Available” check box if the birth date is not given.
First Name
Gender
Ethnicity
Race
Enter the subject’s first name.
Enter the subject’s gender.
Select the subject’s ethnicity – Hispanic or Non-Hispanic.
Select one or multiple Race options.
22 | P a g e
Version Date: 13-Feb-2015
After your subject is added to a study, you will need to go to the On Study tab on the left of your screen
and enter additional information.
Subjects > Subject Console > On Study
On Study Date
Disease Site
Histology
ZIP at Registration
This is the date the subject is registered to the protocol.
Choose from the browse list of disease site codes.
Choose from the browse list of histology codes. This is also a “find as you
type” field; options will narrow down as you begin to type in your histology.
Enter 5 digit ZIP code of patient at the time they are placed on study.
**No Cancer is an option for both Disease Site and Histology if your study is also in including non-cancer
patients. This should not to be used for patients in remission, only patients who never had cancer.
23 | P a g e
Version Date: 13-Feb-2015
5. Entering Subject Deviations
All Deviations and Noncompliance are to be entered in OnCore. They can be entered at a subject
level (Subject Console > Deviations) as well as a protocol level (PC Console > Deviations).



Deviations should be entered at the subject level for all INTERVENTIONAL trials.
Deviations for NON INTERVENTIONAL (SUMMARY ACCRUAL ONLY) trials should be entered
at the protocol level.
SAEs for NON-INTERVENTIAL trials will also be recorded as protocol level deviations.
Subject Console > Deviations tab:


To add a subject level deviation for an interventional trial, navigate to the deviations tab within
the subject console
Click [New] to add a deviation to the selected subject
PC Console > Deviations tab:


To add a protocol level deviation for a summary accrual only trial, navigate to the deviations tab
within the PC Console
Click [New Protocol Deviation] to add a deviation
24 | P a g e
Version Date: 13-Feb-2015
Subject Console/PC Console > Deviations: [New/Update]

Enter all fields that apply
Date Discovered
The date the deviation was discovered. The current date auto- populates in the
field.
Enter person reporting the deviation. The current user auto populates in
Reported By
the field.
Deviation Date
Date deviation occurred or started.
Category
Select the category from the dropdown list.
Treating Physician
Type the physician name and select from the list.
Description of Deviation
Enter informational dialogue regarding the Deviation.
Effect on Patient Safety
Enter information regarding patient safety.
Action Taken
Enter information regarding what has been done to correct deviation now and
in the future.
Did the deviation put the participant or others at increased risk and/or
negatively affect the primary study aims?
Indicate when the deviation was/will be reported to the IRB (immediately or
at the time of continuing review).
Enter the date the deviation was reported to the IRB. If not applicable,
check the ‘Check if not applicable’ checkbox.
Checkbox indicates that the deviation should be reported to the sponsor.
This is usually only deviations/noncompliance that are immediately
reported to the IRB.
Checkbox (yes)
Reported to IRB?
Date Reported to IRB
Report to Sponsor?
Date Reported to Sponsor Enter the date the sponsor was notified of the deviation/noncompliance when
applicable.

Click Submit when all the relevant fields are complete
25 | P a g e
Version Date: 13-Feb-2015
6. Entering Serious Adverse Events (SAEs)
All SAEs are to be entered in OnCore. This includes SAEs that do not meet expedited reporting
requirements for the IRB.


For Interventional trials, SAEs must be entered at the subject level (Subject Console); however,
SAEs can be viewed across all subjects at the protocol level (CRA Console).
For Summary Accrual Only trials, SAEs must be entered as deviations under the PC console
deviations tab
6.1 SAE entry for Interventional Trials
Subject Console > SAEs tab

From the Subject Console > SAE page, click New
Subjects > Subject Console > SAEs tab: [New]

Enter the following fields in the Subject SAE Update section
Event Date
Event End Date
Reported Date
Reported By
Death Date
Day the SAE began (NOT the
day it was discovered)
Date the SAE resolved
Date SAE report was filed
Record the person in charge
of reporting the SAE.
If death occurred, enter the
date.
Cont. on next page
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
26 | P a g e
Version Date: 13-Feb-2015
Death Occurred
Did the SAE occur at your site or at a site for which the PI is
responsible?
Event Narrative
Treating Physician Comments
PI Comments
Protocol Attribution
If death occurred, record the
time frame
Check the checkbox, if the PI
of the Cancer Center is
ultimately responsible for
oversight of the site where the
SAE occurred.
cont. on next page
>>>>>>>>>>>>>>>>>>>>>>>>
>>>>>>>>
Enter informational dialogue
regarding the SAE.
Enter comments from treating
physician if available.
Enter comments from PI if
available.
Select the protocol
attribution from the
dropdown box.
Outcome
Consent Form
Change Required
SAE Classifications**
Check the checkbox if the
consent form should be
changed due to this SAE.
Select the SAE Classification.
**Make sure to include, as this field is often missed.
Entering a Toxicity
Subject Console > SAEs tab, Select Toxicity…

Enter toxicity information using the data entry fields or by using the ‘Select Toxicity…’
hyperlink.
27 | P a g e
Version Date: 13-Feb-2015

When the hyperlink is used, a pop-up window appears with a listing of toxicity description,
code, category, grade, and grade description relevant to the protocol's toxicity scheme.
Subject Console > SAEs tab, Toxicity…
**NOTE: Investigational Tx and individual drugs are listed as attribution options for each study. One
or both may be checked.

The Course Start date should be listed as the beginning of the Protocol Therapy for the
subject
Subject Console > SAEs tab, Tracking Details


Update the Tracking Details section of the SAE as needed.
Once an SAE is complete click the Complete and Lock button**
**NOTE: If an SAE is marked as complete by mistake, this may be undone by contacting an OnCore
Administrator.

Use the [Create Follow-Up] button to add new information to the original SAE as updates
occur.
28 | P a g e
Version Date: 13-Feb-2015
6.2 SAEs for Summary Accrual Only Trials
The SAE tab is only available for individually registered patients, however all SAEs for all studies must be
recorded in OnCore for reporting purposes. As such, SAEs for Summary Accrual Only trials will be
reported as protocol level deviations. Use the following guidelines for entering an SAE as a protocol
level deviation.


All information that would be included on the SAE form must be included in the the description
of the Deviation Section
Fill out the fields in the Protocol Deviation Create as follows
Date Discovered
Date SAE was reported
Reported By
This will auto populate to the name of the person completing the
form
Deviation Date
Should be the start date of the SAE
Category
Select “Other, specify”
Description of
All information that would be entered on the SAE form need to be
Deviation
described in this section. Provide a description of the SAE, identify all
toxicities, narrate any PI comments, and indicate any tracking
information here (see example above)
Action Taken
Add SAE follow-up information in this field
29 | P a g e
Version Date: 13-Feb-2015