OnCore® Clinical Trial Management System (CTMS) Minimum Standardized Requirements: IU Health Statewide Affiliate PROTOCOL ENTRY 
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OnCore® CTMS Registration Requirements Affiliate Entry Flowchart Main Tab Treatment Tab Institution Tab o Affiliates Using IU IRB (or received deferral from IU IRB) o Affiliates Using another LOCAL IRB Accrual Tab Status Tab Reviews Tab o Affiliates Using IU IRB (or received deferral from IU IRB) o Affiliate Using another LOCAL IRB Eligibility Tab Annotations Tab Summary Accrual Info. Only Version 2.0 15 Feb 2016 OnCore Version 14.0 This guide should be followed when entering and updating protocol information for research conducted at Indiana University Health statewide affiliate hospitals. OnCore® Questions OnCore@iupui.edu Phone: 317‐278‐6638 OnCore® Website https://oncore.indianactsi.org/login/ 1 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY OnCore® CTMS Registration Requirements for Research at Indiana University and IU Health This document provides the necessary information to successfully onboard to OnCore and have the necessary fields completed to move toward the onboard with Cerner PowerTrials. Definitions Clinical Study: A research study using human subjects to evaluate biomedical or health‐related outcomes. Prospective: Data collection starts with the present condition of a population of individuals and follows them into the future. Real‐Time Adverse Event Reporting: Adverse events and/or outcomes reporting must as close to event time as possible. (example: FDA mandated Phase IV observational study collecting “real world” adverse events or outcomes) OnCore Protocol Types‐ definitions from Clinical Trial.gov : 1. Observational: Studies in human beings in which biomedical and/or health outcomes are assessed in pre‐defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study. This may include Patient Registries. 2. Interventional: Studies in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed. 3. Expanded Access (e.g. compassionate use): Records describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. Expanded Access records are used to register all types of non‐protocol access to experimental treatments, including protocol exception, single‐patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. See flow diagram on following page: Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 2 Version 2.0, 15 Feb 2016 3 4 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Main > Details PC Console > Main > Details > Protocol Details Field Definition Comments *Protocol No. RPE IIR should be used instead of sponsor for investigator initiated research. Naming convention should be used for ALL protocols. Use when applicable –not all protocols will have a NCT number. NCT number RPE *Library The main identifier for a protocol. This needs to be a unique identifier for each protocol entered in OnCore®. Formatting for identifier: Acronym for Statewide Affiliate Hospital‐Sponsor‐PI‐Short Title of Study Examples: BALL‐SIEMENS‐KOVACS‐EDCP for sponsored study ARNETT‐IIR‐CHEN‐VTS for investigator initiated protocol
National Clinical Trial number found on https://clinicaltrials.gov/
Format example: NCT01956366. Field will not be available the required fields are entered for this page and the data has been saved by hitting the Submit button. A library in OnCore® determines the reference codes, forms, notifications and signoffs for a protocol. The statewide affiliates (see list on pg 4) will use the “Affiliate Only” library. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 5 Version 2.0, 15 Feb 2016 PC Console > Main > Details > Protocol Details (cont.) Field Definition *Department *Organizational Unit *Title Short Title RPE *Age OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY Comments The department is associated with the PI for the study.  If PI is affiliated with the Indiana University School of Medicine, choose that department or division within OnCore.  If the PI has no affiliation with Indiana University School of Medicine, choose the Statewide Affiliate Hospital where the study is conducted. The associated department can also be located in the PI’s staff record: Admin>Staff Console. OnCore Support: OnCore@iupui.edu Organizational units are used to organize protocols into logical structural divisions, which is useful for reporting purposes and to restrict access to protocols. The organizational units available for selection are determined by the organizational units in your staff record. You will be assigned to the both School of Medicine and IU Health Statewide Affiliates.  If PI is affiliated with the Indiana University School of Medicine, choose the School of Medicine as your Organizational Unit within OnCore.  If the PI has no affiliation with Indiana University School of Medicine, choose IU Health Statewide Affiliates as your Organizational Unit within OnCore. This field should always be verified before moving forward as it may auto‐populate with incorrect information. Title is the full length title as listed on the protocol. This should match the title used in the IRB submission and/or clinicaltrials.gov. Please limit to 600 characters. Short Title is an abbreviated version of the protocol title (i.e. sometimes the acronym for the study). Enter the age of the locally acceptable age group. Age is used to indicate the age group of the subjects that are eligible for this protocol, as listed in the protocol eligibility checklist. Based on NIH and NCI Definitions, select from one of the following categories:  Children: Pediatric protocols where subject eligibility is 21 years of age and younger.  Adults: Adult protocols where subject eligibility is 18 years of age and older.  Both: Any protocols where the above age definitions overlap. If you are unable to locate the PI’s name in the Admin > Staff Console, contact OnCore support to add to the directory This field will auto‐
populate once the Library field is entered and should always be verified Studies including children will trigger the Consent at Age of Majority field to display “Yes” and prompt reconsenting of subjects at the age once the reach 18. *Investigator Investigator Authored Protocols are studies that are authored or co‐authored by an Initiated Indiana University/Indiana University Health/Eskenazi/VA investigator regardless of Protocol sponsor/funding (federal, cooperative, consortium, industry). * = OnCore® System Mandatory Field: Cannot submit or advance to next screen until completed. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 6 Version 2.0, 15 Feb 2016 PC Console > Main > Details >Protocol Details Field Definition OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY Comments Summary Accrual Info. Only This field is marked as 'Yes' when only summary subject data will be collected for a protocol. This enables the collection of subject accrual data summaries on the Accrual tab in PC Console, and disables the Subjects > CRA Console > New Subject Registration page. This setting cannot be changed once subjects are accrued to the protocol. **Only observational trials meeting specific criteria may be entered as summary accrual only. *Protocol Type Interventional Study (or Clinical Trial) : A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can RPE evaluate the effects of the interventions on biomedical or health‐related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational Study: A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study). Expanded Access: A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. *Investigational Investigational Drug field is answered as “Yes” if the protocol includes at least one Drug investigational agent. An investigational agent is defined as having an IND number, regardless of the holder. *Investigational Investigational Device field is answered as “Yes” if the protocol includes at least one Device investigational device. An investigational device is defined as having an IDE number, regardless of the holder. PC Console > Main > Details > Accrual Information Protocol Target Accrual is the total number of patients or participants needed for the *Protocol Target Accrual entire study as stated in the protocol or study. This number displays in the top header of most screens within OnCore®. This field is required for protocols that have set accrual goals. If the study is multi‐site this field represents the accrual goal for all sites. *RC Total RC (Research Center) Total Accrual Goal (Upper) is the maximum side of the range of the Accrual Goal estimated total accrual for the institution (cannot exceed the IRB approved Accrual). (Upper) Should be the number approved by the IRB for consented subjects For studies conducted only at statewide affiliate hospitals, this will always be zero. Affiliate Accrual This field should be used for studies that will enroll at any of the suburban or statewide Goal affiliate hospitals (North, West, Saxony, Ball, Arnett, Bloomington, etc.). This number should be the number of subjects approved by the IRB *Accrual Accrual Duration (Months) estimates the number of months the protocol may be accepting patients or participants to accrue. This number should match the accrual Duration duration on the IRB application. This is informational‐only field and does not drive any (Months) OnCore® functionality. See protocol synopsis for estimate.
PC Console > Main > Details>Completion Dates *Primary The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial Completion concluded according to the pre‐specified protocol or was terminated. (Defined by Date ClinicalTrials.Gov). Follow registration guidelines on pg 3 to determine which studies qualify to be marked “yes” Protocol Type should match the Study Type listed on ClinicalTrials.gov. RC includes IU clinics, Methodist, University, Riley and Eskenazi This can be updated at the actual study close‐out. * = OnCore® System Mandatory Field: Cannot submit or advance to next screen until completed. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 7 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Main > Management PC Console > Main > Management > Management Details Field Definition Comments IRB No. RPE Copy, cut, and paste directly from KC IRB (or other IRB record). *ICRC Participation Coding Scheme Internal Account No. Hospital Account No. The Institution Review Board (IRB) number used by the Indiana University Institutional Review Board (or other LOCAL IRB) to track the protocol. If a deferral received from the IU IRB to use a central IRB, the IU deferral number should be entered here. This will always be “no” unless the study utilizes the adult and/or pediatric CRC. The AE and SAE categorization that is being used for the study. If you are unsure of what to choose, MedDRA should be selected. This field is required for any protocol entering SAE data into OnCore or utilizing OnCore eCRFs. Enter the IU “funded” internal account number if PI is an IU affiliated investigator. Not all studies will have The field may also be defined at a research group level. this account no. Use as applicable Enter the IU Health vendor account billing number. Found on the IUH research Not all studies will have grant form. If using another facility’s account (ex. Eskenazi) this field can be used this account no. Use as for both numbers applicable Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 8 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Main > Management > Administrative Groups Management Group All studies will have a selected primary management group. The “primary management group” is determined by your individual department, division, or research group. If your area uses secondary management groups, select the secondary group/groups as appropriate for the study. Management Groups are used for reporting and access privileges. The Primary Management Group must be indicated by checking the associated box. * = OnCore® System Mandatory Field: Cannot submit or advance to next screen until completed. PC Console > Main > Staff Be sure to tick the “primary management group” even if there is only one management group listed. PC Console > Main > Staff > Protocol Staff Field Definition Role RPE Comments At a minimum: Principal Investigator: PI for the study. There will be only one principal investigator per study. Co‐Investigator: Other physicians acting/intervening with subjects. Research Nurse: RN/LPN coordinator Research Coordinator: non nurse coordinator PowerTrials Creator: Role to be used ONLY if study will be registered in Cerner PowerTrials. This role will be the person that will receive Cerner Power messages, and may maintain PowerTrials fields that the RPE does not affect. The recommendation is to have two PowerTrials Creators listed for each study. Data Coordinator: Staff supporting OnCore entry (use if applicable in the research area) Protocol Creator: This is automatically assigned to the initial creator of the protocol in OnCore (do not delete this role). Study Site Contact: Primary coordinator for the study Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 9 Do not use Affiliate PI or Affiliate Coordinator for any staff member that needs to be identified in Cerner PowerTrials. Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY Comments Field Definition Staff Name Select the staff member you want added to the protocol (this is a find‐as‐you‐type field that pulls from all active staff records). A staff member may be listed multiple times with different roles on a single protocol. OnCore@iupui.edu If you cannot find a staff member, contact OnCore support and request the staff member to be added to the directory. PC Console > Main > Sponsor PC Console > Main > Sponsor > Sponsor Details Field Definition Sponsor Details Comments All sponsors associated with the protocol. Each study must have a primary sponsor indicated. This is done by checking the Principal Sponsor box next to the appropriate sponsor. The Primary sponsor is the primary organization that oversees the implementation of a study and is responsible for data analysis. If your sponsor is not found, contact OnCore Support to have added to the directory OnCore Support: OnCore@iupui.edu Always check the primary sponsor, so sponsor will be identified in banner bar. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 10 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Main > IND/IDE PC Console > Main > IND/IDE/Details Field Definition *ID *Holder Type Comments IND or IDE number assigned by the FDA.  Select Industry if IND/IDE is held by a pharmaceutical company.  Select Investigator if IND/IDE is held by IU/IUH Principal Investigator or other IU/IUH faculty.  Select NIH if IND/IDE is held by the NIH.  Select Organization if IND/IDE is held by an organization other than Industry, NCI or NIH. The holder of the IND/IDE. Often this is a PI name, study sponsor name or cooperative group name. * = OnCore® System Mandatory Field: Cannot submit or advance to next screen until completed. *Holder Name Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 11 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Main > ClinicalTrials.gov PC Console > Main > ClinicalTrials.gov > Responsible Party Field Definition Responsible Party This field is applicable for ClinicalTrials.gov studies only and refers to the Sponsor, Principal Investigator, or Sponsor‐Investigator who is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information  Sponsor: the entity (e.g., corporation or agency) that initiates the study  Principal Investigator: the individual who serves as the principal investigator and is designated as responsible party, consistent with the conditions described in the statute  Sponsor‐Investigator: the individual who both initiates and conducts the study Comments Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 12 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Treatment Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 13 Version 2.0, 15 Feb 2016 PC Console > Treatment > Details > Add Protocol Step Field Definition Step Code Step Type Arm Code Arm Description OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY Comments Defines the step(s) in the protocol. This field permits up to 4 characters which must be unique per protocol. Once a step is added to the protocol, arms for that step can be created by selecting the associated Arms link. This field defines the step as “Registration” or “Randomization”. This is a short identifier for the arm. This field is limited to 10 characters and will display on calendars, Reports, DSMC Console, and other locations These are some examples that can be used: BLINDED: use for blinded/randomized trial. Describe the arm in the Arm Description. Device/Drug Name: For unblinded studies, use device or drug name as code. Placebo/SOC: For unblinded studies, use if there is a control arm. REGISTRY: Use for registries or observational studies **Use best judgment when naming arms if above codes are not appropriate. A description of the arm limited to the size of the field. (i.e. study drug/placebo). This includes protocols where there is no treatment such as specimen banking protocols and registries. **Levels should only be used for arms with dose escalation. Never use Levels to indicate additional arms. All protocols must have at least one step. A study may have one arm or multiple arms available. OnCore will permit subjects to be assigned to multiple arms. Protocols must have at least one arm entered to provide functionality to calendars / financials. Arms may also be used to identify different phases within a trial (e.g. Phase I/II). Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 14 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Institution USING IU IRB or have received a deferral from IU IRB to a central IRB USING another LOCAL IRB For Studies using a LOCAL IRB other than IU IRB, the “Uses Research Center “should be No Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 15 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Institution > Institution Hyperlink > Study Sites PC Console > Institution > Participating Institutions Field Definition Institution Study Site / Study Participant Represents the entity participating in a protocol. For system management reasons‐
Indiana University (IU) is considered the research center (RC) and currently includes University, Riley, Methodist, and Eskenazi hospitals as well as multiple clinic sites. All other institutions are considered affiliates (AFF). Other IU Health statewide affiliate hospitals are listed as separate institutions. If the institution you are searching for is not available, contact OnCore support staff for assistance. “Institutions” and “Study Sites” listed should correspond with sites listed in IRB submission. The “Uses Research Center” box:  If Using IU IRB, or have received a deferral from IU IRB to submit to a central IRB: Box should be ticked “Yes”  If using another LOCAL IRB (ex. Ball Hospital IRB): Box should not be ticked to indicate “No” **Do not forget to then add the “Study Site” to the individual “Institution”. All Institutions (Other than Indiana University) will require Protocol status updates AND Institutional status updates. Indicates the physical location where subjects are enrolled. At least one Study Site must be listed per protocol in order for subjects to be registered in the system. To select a study site, click on the Institution name and then click the “Study Site” tab. Check the “Study Participant” box next to the appropriate sites and “Submit” the information. This field must be checked in order for the study site to display in the Study Site dropdown field on the CRA Console > New Subject Registration page. This field cannot be edited once a subject has been registered at the selected site. Comments Only enrolling institutions need to be added here. The Status of each institution listed must be updated to Open to Accrual in order to register subjects. Only enrolling study sites need to be added here. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 16 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Status > Protocol Status PC Console > Status > Protocol Status Field Definition Status RPE Comments Statuses are assigned and unassigned in a predetermined order. Detailed definitions can be found below. OnCore statuses should be kept up to date so they accurately reflect the current status of the protocol. Status information will also be reflected in Cerner PowerTrials for qualifying trials. IU Health Statewide Affiliate Hospitals are required to update the PROTOCOL Status here AND the Institution Protocol Status. REQUIRED Status Types: IRB Initial Approval Open to Accrual Closed to Accrual Suspended On Hold Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 17 Individual research groups may decide to utilize "Protocol Signoffs”. See additional information in the definitions. Version 2.0, 15 Feb 2016 Date RPE Initiator Reason OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY Terminated IRB Study Closure Abandoned New: Status automatically assigned when a protocol is initially entered in OnCore. The current date is also assigned at this time, but may be edited. IRB Initial Approval: Status automatically populates into the Status tab when the IRB Approval is entered in the PC Console→Reviews tab. Protocol Signoffs: After the 'IRB Initial Approval' status occurs, Protocol Signoffs (e.g. 'Central Admin Signoff', 'Account Signoff') may be required. These are determined by individual research groups and will not allow you to ‘Open to Accrual’ until all signoffs are complete. Staff with appropriate access will be notified to complete these signoffs and will be the only staff members that can advance the protocol. On Hold: Trial has not yet opened to accrual and the PI or Sponsor has requested that all work on the trial stop until an issue, e.g. contract, funding, drug supply, etc. is resolved. Trial status may also be changed to “On Hold” if a protocol amendment requires IRB approval before a trial can open to accrual. A study can be placed on hold more than once during a trial’s start‐up period. Abandoned: Study has been withdrawn before it was IRB approved and no further action is expected. Open to Accrual: Status selected after the site has been opened to accrual/enrollment (all required reviews complete, sponsor authorization obtained, research group fully prepared to begin seeing patients). Suspended: Status selected after “Open to Accrual” to indicate that the protocol and subject accrual have been temporarily suspended. Once a trial has suspended, the user is given the option to “undo suspend”. The “undo suspend” option should only be used in cases that the trial was suspended by accident (i.e. clicked on the wrong button). Clicking “undo suspend” will erase the trial suspension from the status history. Closed to Accrual: Status selected when the protocol is no longer accruing/enrolling subjects. IRB Study Closure: Status selected to indicate that protocol ran its intended course (was not abandoned or terminated) and was closed with the IRB. This can also be used to indicate a study has expired and will not be reapproved. Terminated: Status selected to indicate that the protocol ended prior to completing the expected outcome and has been terminated with the IRB. It may also be used after the IRB study closure to indicate that no further action is required on the trial (i.e. financials reconciled). The date the status became active. This date may be retroactive, but future dates may not be entered. The initiator of the decision to activate the status listed.
The reason for activating the status listed.
Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 18 Required for the following statuses: 
On Hold 
Abandoned 
Suspended 
Closed to Accrual 
Terminated Required for the following statuses: 
On Hold 
Abandoned 
Suspended 
Closed to Accrual 
Terminated Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Institution > Institution Hyperlink > Status PC Console > Institution > Institution Hyperlink > Status Field Definition Status Date Initiator Reason IU Health Statewide Affiliate Hospitals are required to update the PROTOCOL Status AND the Institution Protocol Status shown here. The following are the Institution Protocol statuses: Account Signoffs Abandoned Open to Accrual Suspended Closed to Accrual Terminated The date the status became active. This date may be retroactive, but future dates may not be entered. The initiator of the decision to activate the status listed.
The reason for activating the status listed.
Comments Definitions for institution status are the same as for protocol statuses. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 19 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Review > Update IRB Review USING IU IRB or have received a deferral from IU IRB to a central IRB 02/01/2015 USING another LOCAL IRB Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 20 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Reviews > Review Information Field Definition Comments Review Date Submit Date The date of the IRB review was conducted. If this date is unknown, you may enter the IRB approval date. The date the submission is sent to the IRB.
This date is located in KCIRB or other IRB system.
Review Reason The reason for the IRB submission. The following IRB reviews at minimum are required to be entered within OnCore: Initial Review: Initial IRB submission Continuing Review: use for continuing reviews (both open and closed to enrollment) Change Review(Amendment): use for all amendments Additional IRB reviews are optional. Review Type Action RPE Action Date The type of IRB review will either be “Full”, “Expedited”, “Exempt”
The IRB’s decision regarding the submission reviewed. The following IRB Actions are common actions that will be used : Approved: Required in order for a protocol to be opened to accrual The date of the IRB’s action. For new protocols that have been approved by the IRB, the Action Date = the protocol approval date. The date the current IRB approval expires. The expiration date of the review will automatically become the expiration date for any documents included in the details section of the review (e.g. Consent Documents). **DO NOT enter Expiration Date for the “Dummy” IRB review. The expiration date will be entered in the Institution Specific IRB Review.
The submission number for a review record of a specific review reason for this protocol. Additional Actions are available for tracking purposes. All Action dates are located in KCIRB or other IRB system. The expiration date is located in KCIRB or other IRB system. Expiration Date Review No. Institution The review number should reflect the KCIRB review number or if using For Institutions using the IU IRB: an External IRB Minimum: Enter NS for “New Study”,A001, A002, etc for amendments, R001, R002, follow the etc. for continuing reviews. numbering system for the specific For those studies reviewed by Central IRB or other local IRB, these fields many not company‐WIRB or be applicable. CIRB. After the IRB Review is created, this field will display the Research Center institution by default. Use the Edit link to display a pop‐up window where additional institutions can be selected to share this review. The pop‐up window will only display those institutions that have been designated as using the Research Center IRB. Required for studies not using the IU IRB for approval or deferral (those institutions that DO NOT tick “uses RC IRB”). These fields must be entered for the RPE to function properly and should be the only fields entered for “Dummy” reviews. ** Full IRB information will then need to be entered into the Institution’s IRB Review—see next page. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 21 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Institution > Institution Hyperlink > IRB Reviews PC Console > Institution > Institution Hyperlink > IRB Review Field Definition Submit Date The date the submission is sent to the IRB.
Committee Review Reason Review Type Action Action Date Enter the IRB of record for the protocol.
The reason for the IRB submission. The following IRB reviews at minimum are required to be entered within OnCore: Initial Review: Initial IRB submission Continuing Review: use for continuing reviews (both open and closed to enrollment) Change Review(Amendment): use for all amendments The type of IRB review will either be “Full”, “Expedited”, “Exempt”
The IRB’s decision regarding the submission reviewed. The following IRB Actions are common actions that will be used : Approved: Required in order for a protocol to be opened to accrual The date of the IRB’s action. For new protocols that have been approved by the IRB, the Action Date = the protocol approval date. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 22 Comments This date is located in KCIRB or other IRB system.
Additional IRB reviews are optional. Additional Actions are available for tracking purposes. Version 2.0, 15 Feb 2016 Expiration Date Review No. OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY The date the current IRB approval expires. The expiration date of the review will automatically become the expiration date for any documents included in the details section of the review (e.g. Consent Documents). The submission number for a review record of a specific review reason for this protocol. These fields many not be applicable depending on IRB of record. PC Console > Reviews > IRB > Details (protocols using the IU IRB) PC Console > Institution > Institution Hyperlink > IRB Review > Details (Protocols using another LOCAL IRB) *The following details will be added for the IRB Review Field Definition Comments Type Detail for any item submitted to the IRB. The following items are required at a minimum. Consent‐HIPAA‐HIPAA authorization. Consent‐ XXX‐All other IRB approved consents; use most applicable consent option (i.e. Consent‐ Assent, Consent‐ Treatment, Consent‐ Tissue). The values in this field allow the consents to become available in the Subject Console>Consent tab for selection. NOTE: Uploading of documents is not required and will be left up to the research groups to manage these documents according to their internal guidelines The amendment number listed in KCIRB or other IRB system.
Example: A001 matches KCIRB for amendment 1. “Type” needs to remain consistent across all reviews within a protocol. Version Date The version date of the document associated with the IRB review. Description Reconsent Required Free text to add description of the document.
When an amendment includes an updated consent form, this checkbox can be used to indicate a re‐consent requirement for enrolled subjects. Checking this checkbox causes a » link to appear. Click the link to indicate whether the re‐consent should apply to subjects with a status of On Treatment (including 'On Arm' and 'Off Arm'), subjects with a status of On Follow‐Up, or both. This will cause an 'RR' superscript to appear next to each subject's name in the CRA Console until the subject has been re‐consented. Amendment No. Allows tracking of re‐consent of subjects. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 23 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Accrual PC Console > Accrual Field Definition Comments NA Displays detailed subject accrual data for the protocol. Depending on privileges, subjects listed in the Accrual Details table link to the corresponding subject record in the Subject Console. This screen shot is to demonstrate the accrual tab in the PC console. This displays when subjects have been registered to the protocol in the Subject Console Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 24 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Eligibility PC Console > Eligibility Field Definition Comments NA Subject eligibility is recorded on the Subject Console > Eligibility page. It will show up on the Eligibility tab in the PC Console. PC Console > Annotation Field Definition “Annotations” Comments The annotations page is where protocol annotations are viewed and updated. Protocol Annotations are used to collect protocol data that is not accounted for by standard OnCore fields. Work with OnCore Support to develop specific annotations for your research group. *The only required annotation for all protocols: Study to be pushed across RPE? Yes or No (This annotation provides a quick reference for which protocols will be pushed to PowerTrials) Each research group may set up their own set of annotations. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 25 Version 2.0, 15 Feb 2016 OnCore CTMS Minimum Standardized Requirements IU Health Statewide Affiliate PROTOCOL ENTRY PC Console > Accrual> For “Summary Accrual Info. Only” is marked “YES” on Main > Details >Accrual Summary Accrual Info. Only This displays only when the Summary Accrual Only field is marked as 'Yes' for a protocol. This enables the collection of subject accrual data summaries on the Accrual tab in PC Console, and disables individual subject registration. This setting cannot be changed once subjects are accrued to the protocol. PC Console > Accrual > Add Protocol Accrual Field Definition Comments From Date to Through Date Use when Recording Summary Accrual Only Info. Accrual Institution Institution Type Date range for the accrual data being captured. Data should be captured by month (i.e. monthly ‐ Jan 1 to Jan 31). This allows for flexible reporting. Start date should not be prior to the Open to Accrual Date. Thru Date should not exceed the Close to Accrual Date. Number of subjects accrued for the criteria defined (i.e. Age/Race/Sex/Ethnicity/Recruiter). To be consistent with IRB subject count authorization, it is recommended that a subject be counted as "accrued" once the subject has been consented. Select the Institution that accrued the subject. This list should populate with a drop‐down based on the Institutions entered under the PC Console > Institutions. Identifies the Institution type (VA, Research Center, Affiliate, Consortium Member). This should populate based on the Institution selected Use when Recording Summary Accrual Only Info. Use when Recording Summary Accrual Only Info.
Use when Recording Summary Accrual Only Info. Yellow Highlighted = Required Field RPE: Field used by the RPE to pass information from OnCore to Power Trials 26 Version 2.0, 15 Feb 2016