Protocol Review Committee
The PRC is charged with the scientific evaluation of all cancer clinical protocols and amendments proposed at Yale prior to initiation. PRC review encompasses an assessment of the scientific rationale and merit of a proposed study in addition to protocol design, safety parameters, and biostatistical analysis to determine that high quality and appropriate designs have been incorporated. The review of the informed consent document focuses on scientific accuracy and ensures subjects are informed of risks, side effects and any alternative treatments.
- The committee assigns a priority score that considers scientific merit and other available studies and is based upon an averaged points system.
- The committee assigns a Data and Safety Monitoring Plan (DSMP). This plan consists of an audit schedule and a timeline for the PI to submit data and safety monitoring reports for review by the Data and Safety Monitoring Committee (DSMC). The DSMP takes into account the risk of the study in the context of any monitoring that may be provided by an external sponsor, cooperative group, or consortium.
Guidelines for Submission- New protocol
All submissions must include:
- A copy of the Clinical Research Steering Committee/Protocol Review Committee Submission Form with the required signatures of the PI and disease unit leader. **In the event of a vacancy in Disease Unit leadership, the signature of the section chief or department chair is required.
- Letter of approval from the Clinical Research Steering Committee
- Final protocol (not the HIC application)
- Investigator’s Brochure (as applicable)
- Yale HIC formatted Informed Consent forms
- Sponsor master consent (as applicable)
Guidelines for Submission- Amendments
All submissions must include:
- PRC Amendment Request Form
- Amendment log indicating the history of all amendments made to the study
- Each research study document being amended with changes noted in track change format (do not submit HIC application)
- Each research study document being amended incorporating all changes (do not submit HIC application)
- Each new research study document being added as a result of the amendment (i.e. consent addendum, recruitment materials, etc.)
- If amendment is initiated by the sponsor, include the sponsor's correspondence and the sponsor's summary of changes
The YCC PRC does not need to review the following amendment types:
● Amendments to Cooperative Group studies.
- Cooperative Groups include COG,GOG,RTOG, CALGB, ECOG,SWOG, NSABP, and NCIC. Upon receipt from the sponsoring cooperative group, amendments may proceed directly to the IRB. You do not need an acknowledgement letter (sometimes called skip letter) from the PRC prior to submission.
● Amendments to non-therapeutic studies. These amendments should be submitted directly to the IRB.
However, both Cooperative Group and non-therapeutic studies should be submitted to SC/PRC for review prior to IRB approval for the initial application, but not for amendments.