Submit for Cancer Center Scientific Review Committee (SRC)

Per the ePRMS Bylaws: 

Criteria for selection of protocols for review¹

The SRC is responsible for review of all prospective cancer related research at the IUSCCC, including clinical, translational, and laboratory-based protocols for which a Cancer Center member is an investigator. In addition, regardless of School, Department affiliation, or Cancer Center membership of the investigator, a protocol may require review if the conduct of the protocol requires the direct participation of or access to biological specimens from or access to medical records of patients with cancer or at immediate risk of cancer. The policy of SRC review was developed by the Cancer Center Director with the approval of the Deans of the IU School of Medicine and the IU School of Nursing and the Executive Committee of the IU School of Medicine. 

The Chair of the SRC is available for consultation in the case of uncertainty of the necessity of SRC review. The IU IRB requires investigators to indicate if the submitted protocol requires the participation of patients with cancer, including their medical records or biological samples. The IU IRB will not approve such trials without SRC approval. In ambiguous circumstances, the IRB will consult with the SRC Chair.

There may be some studies that do not require PRMS review, such as Expanded Access.  Please reach out to the SRC Coordinator for additional clarification if needed: crosrc@iu.edu.

1. Cancer Center CTO-Managed SRC Submission Process

If a study is being managed by the Cancer Center’s Clinical Trials Office (CTO), then the study should be created and submitted in OnCore via the PRMS Console.

1. • • CTO teams: please use the SRC ePRMS guidance document located here.
       
       
2. Non-CTO Managed SRC Submission Process

If a study is being managed by a Non-CTO Study team and the trial is 1) a cancer relevant study and 2) is an investigator-initiated trial (IIT) (Sponsor Type: Institutional), then the study should be initiated via the Office of Clinical Research (OCR) process to create the protocol shell in OnCore.  

• • • Non-CTO Teams: please notify the Cancer Center’s Protocol Development Team (PDT) at jsastre@iu.edu once OCR has created the protocol in OnCore.  The Cancer Center PDT team will submit this to SRC on behalf of the study team.

If a study is being managed by a Non-CTO Study team and the trial is 1) a cancer relevant study and 2) the trial is any trial type other than an investigator-initiated trial (IIT) (Sponsor Type: Consortium, Externally Peer-Reviewed, Industry, or National), then the study should be initiated via OCR process to create the protocol shell in OnCore.   

• • • • Non-CTO Teams: please notify the Cancer Center’s Protocol Development Team (PDT) once OCR has created the protocol in OnCore. The Cancer Center PDT team will submit this to SRC on behalf of the study team. This is an optional, free service that PDT provides. 
      • If you are not interested in using this option, you should follow the steps below.
        • • Follow the instructions received from OCR via email with how to create the record in PRMS and submit for review. 
          • Please also use the SRC ePRMS Submission Guidance Document for additional instructions on this process.

Please note, non-cancer relevant studies that are not submitted for review by the IUSCCC SRC may require review by the CTSI SRC. Details of this review committee can be found within the Submit to CTSI Scientific Review Committee tile on the Activation Roadmap. 

The IU Simon Comprehensive Cancer Center offers many resources to assist you in your SRC Submission. You can refer to the IU Simon Comprehensive Cancer Center’s internal website at IUSCC Intranet: Indiana University Melvin & Bren Simon Cancer Center or review the IUSCCC Protocol Review and Monitoring System Bylaws here for more information on topics such as:  

• SRC ePRMS Submission Guidance Document (This guidance document outlines the steps to submit your protocol to SRC for review, along with explaining all required documentation needed for submission.
• SRC Submission Deadlines & Meeting Dates

• An approval letter from the Cancer Center SRC is required prior to IU IRB approval². (This is also the case for any studies being overseen by an outside IRB of record. A Cancer Center SRC approval letter must be submitted to IU IRB in order to receive any reliance approval from IU IRB to utilize an outside IRB as the IRB of record for a study.)
• Protocol amendments that involve major scientific changes may need review by SRC prior to implementation. Examples include but are not limited to additional arms, removal of treatment arms, additional study populations, significant changes in medication doses and/or radiation exposure, and DSMP changes.  The PI or other study team may consult the SRC Coordinator for clarification of any amendment in question³.
• Protocols not accruing according to timelines listed in OnCore are subject to the Cancer Center’s PRMS review by Protocol Progress Committee (PPC) too. Each active trial will be reviewed for current accrual compared to the expected/predicted accrual. The IU PI is ultimately responsible for responding to the PPC. The PPC subcommittee may review rationale and/or criteria as needed or requested by the PI. The PPC recommendation to close studies for low accrual is submitted to the SRC for consideration and recommendations regarding closure of the trial. Accommodations may be made for rare tumor subtypes (see section on “Rare Tumor Trials” below). Upon SRC recommendation, the SRC coordinator will close to accrual the low accruing studies.⁴ Please note that there is an appeal process regarding PPC’s decision if appropriate justification can be provided. This process is outlined in the PPC outcomes letter received by the trial’s PI at the time of PPC review.)
• Principal Investigators may have to undergo additional training and credentialing for cancer related protocols.
• IU OnCore account: To submit to the Cancer Center’s SRC, you must have an IU OnCore account.