Clinical Research Operations

Urologic Oncology Branch (UOB) Scientific Review of Clinical Trials

Purpose: Protocol documents will be reviewed by the Urologic Oncology Branch Scientific Review Committee (UOB SRC) prior to submission to the Institutional Review Board (IRB) to ensure the protocol is scientifically sound, supported by strong rationale, has a good biostatistical foundation, is likely to accrue the targeted population, and has the potential to make important contributions to the scientific field.  

The protocols will be reviewed for scientific validity, translational and preclinical development, quality of content, biostatistical foundation, ability to accrue the targeted population, as well as adherence to regulatory and Center for Cancer Research (CCR), National Cancer Institute (NCI) requirements and guidelines prior to submission to the IRB.

The final responsibility for scientific review lies with the Branch Chief except in the event the Chief is the principal investigator, in which case the final responsibility lies with the Scientific Director.

Step 1: Submit proposed protocol to UOB Scientific Review Committee

Protocol documents will be submitted to the Urologic Oncology Branch Scientific Review Committee (UOB SRC) to perform a review of research protocols prior to submission to the Institutional Review Board (IRB).

• Protocol Input:
  • Receipt of protocol documents
    The Principal Investigator or designee will submit an electronic (WORD) version of the protocol and the Strategic Alignment and Resource Planning Checklist at least 10 calendar days prior to the SRC Meeting to the NCICCR Protocol Support Office (PSO) at: nciprotocolsupportoffice@mail.nih.gov.
    
• Distribution of protocol documents:
  • A copy of the protocol will be distributed to the UOB Scientific Review Committee, CCR Statisticians Drs. Seth Steinberg and/or Joanna Shih for statistical review at least 7 calendar days prior to the UOB SRC Meeting. 
  • A copy of the protocol to the CC Pharmacy contact member for pharmacy review, if needed.  
  • The Chair will assign a primary and secondary reviewer; who will receive the protocol for review at least 7 calendar days prior to the UOB SRC Meeting.  If it is determined the Scientific Review Committee does not have scientific expertise for the protocol being reviewed, Ad Hoc reviewers will be solicited by the SRC Chair. 
    • Primary reviewers may not have a conflict of interest (COI) on the clinical trial under review.
    • If the secondary reviewer is an AI, a general expert not associated with the trial must be involved in the review and vote.
  • The primary and secondary reviewers will provide written comments at least one day before the meeting. 
  • Protocols will be reviewed for regulatory and administrative issues by the PSO prior to/simultaneously with Committee review.

Step 2: Protocols must undergo comprehensive scientific review by a Scientific Review Committee with requisite scientific knowledge prior to NCI IRB submission

The protocols will be reviewed for scientific validity, translational and preclinical development, quality of content, as defined in the attached Assessment Checklist. This review will also ensure the protocol will meet regulatory and administrative requirements prior to submission to the IRB. 

• Review Process:
  • The UOB Chief, SRC Chair, primary and secondary reviewers and committee members will convene to review the protocol as outlined in the attached Assessment Checklist.
  • All reviewers will meet at a scheduled date/time to discuss the protocol. An agenda will be sent and minutes will be taken by a minute taker at the meeting.
  • The SRC Chair will preside over the meeting.  Five (5) members (including standing members and/or ad hoc/rotating members) will represent a quorum. In the absence of the Chair, the Chair will assign a designee.  If the SRC Chair is the Principal Investigator on the protocol under review, the Chair will assign a designee to Chair the meeting.
• Scientific Review Committee Meeting:
  • The PI should give a short (15 minute max) presentation emphasizing the following:
    • overall goals of the trial, with scientific and background rationale
    • scientific design with statistical analysis
    • patient population
    • procedures involved and correlative studies
    • expected resources required.  If additional resources are required, the CCR Office of the Clinical Director should be contacted to request additional support.
  • The PI (or designee) will be present and participate in the discussion, answer questions and receive constructive input.
  • Protocols will be reviewed by members present using the NCI/UOB Assessment Checklist (attached).
• Review Process:
  • Following the meeting, the minutes will be emailed to SRC Chair and reviewers for review and approval.  All individuals from the Branch and outside reviewers may submit comments to the PSO no later than COB the day after the review, but only UOB SRC committee members and ad hoc reviewers present at the meeting will vote.
  • The minutes will be uploaded into iRIS, and the outcome will be sent to the PI within 5 business days after the review with a copy to the statistician(s).

Step 3: Scientific Protocol Review approval process will be documented

The voting outcomes for a protocol will be “Approved as written,” “Approved with stipulations/recommendations,” or “Disapproved.”

All UOB SRC committee members and ad hoc reviewers are eligible to vote.  At the conclusion of a protocol presentation, the UOB Chief or SRC Chair will ask the PI and any AI(s) to leave the room for voting purposes.  The voting will be completed via a ballot and the count will be included in the Protocol Summary. 

The majority of votes will determine the outcome of protocol.  In the event of a tie, the Branch Chief will make the decision.  Note:  If it is the Branch Chief’s protocol, the SD will make the decision. 

• APPROVED AS WRITTEN:
  • If the protocol is approved (with no stipulations/recommendations), the outcome letter, electronically signed by the UOB Chief and/or designee and the SRC Chair will be sent to the PI via iRIS.
• APPROVED WITH STIPULATIONS/RECOMMENDATIONS:
  • If protocol is approved with stipulations/recommendations:
    • The PI should submit a response via iRIS within 14 calendar days after the review.  This should include a copy of the protocol with tracked changes, as well as a copy of the clean version of the protocol, and rationale (comments) for any stipulations not completed.  Under special circumstances (for instance, when comments/protocol changes are required from an outside sponsor), the PI may seek an extension from the SRC chair and/or the Branch Chief.  Per CCR policy, responses not received within 14 days require resubmission of the protocol for scientific review.
    • If stipulations require statistical changes, the revised documents will be forwarded to the statistician(s) for final review.
    • Protocol documents will be re-reviewed by the UOB SRC Chair to ensure all feedback has been adequately addressed prior to NCI IRB submission.
    • If adequately addressed, the Committee Chair with the Branch Chief co-signature will provide approval of the document(s) within 5 calendar days.
    • If additional comments, recommendations or stipulations are indicated, the Committee Chair will submit these in writing to the PI within 7 calendar days
• DISAPPROVED
  • The protocol needs significant scientific revision and will need to be resubmitted to the SRC for full review.
  • Approval documentation:
    • The Branch Chief of the PI will have the final approval for Scientific Review, except in the event the Chief is the principal investigator, in which case the final approval will be obtained from the Scientific Director.
    • Upon receipt of SRC approval, the PI will submit the protocol documents with the approval document to the NCI IRB via iRIS, within 7 calendar days or by the next IRB deadline.

Step 4: Amendments with substantive scientific changes will be reviewed by the statistician and Scientific Review Committee

• Review of Amendments:
  Amendments should be discussed with the Committee Chairperson(s) to determine requirements for Scientific Review, using the following guidelines:
  • Statistician(s) and Scientific Review Committee required:
    • A change in protocol primary objectives.
    • Treatment or agent(s) change(s) that materially affect trial evaluation.
  • Statistician(s) review required and Scientific Review at the discretion of the Chair:
    • Change in trial design of more than trivial consequence.  For example, adding arms or removing arms to a randomized or phase II trial, or changing stratification factors.
    • Adding additional patients to a phase II trial other than replacement of in evaluable patients.
  • The following amendment changes do NOT require review by the statistician(s) or Scientific Review Committee:
    • Adding cohorts to a phase I trial after failure to reach MTD.
    • Adding limited patients for more than anticipated in evaluable patients or to keep positive study open until implementation of a subsequent trial.
    • Minor changes considered administrative, regulatory or of limited scientific concern.

Step 5: Activities/actions of the clinical trials review process will be documented

Data documentation (metrics) will be available for evaluation of the clinical trials review process.

Interdepartmental Communication Reports will inform affected individuals/groups of new clinical trials efforts to allow for pre-planning.

Urologic Oncology Branch Scientific Review Committee

MEMBERSHIP

*Not counted in the quorum

NCI-UOB Assessment Checklist: Scientific Review of Clinical Trials

View/Print the NCI-UOB Assessment Checklist.