A study must be reviewed by the Protocol Review and Monitoring Committee (PRMC) in order to be listed as a West Virginia University Cancer Institute protocol. Furthermore, the WVU IRB requires that all cancer-related clinical research protocols involving human subjects and participants (including clinical, prevention, translational, population, and behavioral studies) be reviewed by the PRMC before IRB consideration.
The Protocol Review and Monitoring Committee (PRMC) is responsible for the West Virginia University Cancer Institute Protocol Review and Monitoring System (PRMS). The Protocol Review and Monitoring Committee supports the clinical, basic, and population health research of the Center by providing protocol review (and associated feedback to assist in LOI and protocol development, pre-award) and study monitoring (post award) A sub-committee, Population Sciences and Bio-Behavioral Research Committee, will oversee all population health protocols and will interact directly with the PRMC.
The PRMC reviews all cancer related protocols conducted at the institutions affiliated with West Virginia University Cancer Institute, including protocols sponsored by the National Clinical Trials Network, and the pharmaceutical industry. Population science and bio-behavioral studies involving cancer patients, and other target populations or communities are also reviewed.
Requirements for Submission to the PRMC
A complete protocol including all sections outlined in the linked template or the equivalent must be present. (Protocol Template) Investigator-initiated trials, should include a statistical section developed in consultation with a West Virginia University Cancer Institute biostatistician.
Investigator-initiated protocols must be pre-reviewed by the appropriate Scientific Disease Team and/or the following specialty committees: Stem Cell Biology and Bone Marrow Transplant Committee; and the Early Phase I/II Trials Committee. The PRMC Submission Form to be completed by Disease Team/Committee leader and Principal Investigator. PRMC Submission Form
The following list shows the forms to be submitted to PRMC Coordinator, Katie Clark.
- Protocol with consent (if available)
- PRMC submission form signed by Disease Team leader and Principal Investigator
- Protocol Information sheet required for submissions not being supported by the CRU and Non-Treatment/Chart Review protocols for entry into OnCore. (WVUCI clinical trials database)
Review of New Protocols
Prior to the meeting of the PRMC, two or three members are designated by the Chair and PRMC Coordinator to review each protocol. Additional reviews will be conducted by, a biostatistician, investigational pharmacist, research nurse/coordinator.
The PRMC ensures that each clinical trial has an appropriate statistical analysis section, a realistic accrual goal as well as a Data and Safety Monitoring Plan (DSMP), if appropriate.
The PRMC evaluates the scientific merit of proposed protocols, appropriateness of the target population, risk assessment, data safety monitoring plan and the adequacy and appropriateness of patient care. The PRMC also considers the priority vis-à-vis other active protocols in the WVUCI, generally taking the recommendations of the Scientific Disease Teams and the Population Science and Behavioral Research subcommittee.
Population Science and Bio-Behavioral protocols are reviewed in a similar manner to therapeutic protocols by a special dedicated committee for these types of studies under the authority of the Medical Director for Clinical Trials. This subcommittee of reviewers also includes members of the Cancer Prevention, Control and Population Research Program, in addition to members of the PRMC with content expertise in the disease or study topic. The Population Science Research Program membership has broad expertise in cancer control research. They assess the scientific merit of the non-therapeutic trial, and represent this review to the PRMC.
National group trials are administratively reviewed by the PRMC. The Clinical Trials Disease Team completes the required PRMC Submission Form, the research nurse/coordinator submits the Research Coordinator sign-off document and enters the protocol into OnCore. The protocol is then forwarded to the Investigational Pharmacist for review. Once all the review forms are completed, the cooperative group protocol is then reviewed by the PRMC chair or co-chair and either administratively approved or forwarded to the PRMC for full review.
Retrospective Chart Review studies will be reviewed by the Committee Chair (or his designee) and included in the PRMC minutes. Submission of chart review studies to the PRMC will not delay IRB submission or IRB approval. IRB processing can occur simultaneously. Forms required for PRMC submission are: Protocol Information sheet along with the research plan. See West Virginia University Cancer Institute "Blue Book" for more information for chart review research plan guidelines. The number of charts reviewed and used for analysis must be reported to the PRMC Coordinator upon completion of the research.
PRMC Recommendations and Priority Score
The PRMC assigns a priority score, range 1.0 to 5.0 (1-Outstanding, 2- Excellent, 3 - Good, 4 - Acceptable, 5 - Not Scientifically Meritorious), for the protocol (investigator-initiated trials are highest priority; all other studies can receive a score no lower than 3.0).
The PRMC is also charged with assigning a risk level to each research study using the following scale:
- High risk (e.g., gene therapy, phase I, BMT trials)
- Medium risk (e.g., Phase I/II trials with intervention of expected moderate toxicity)
- Low risk (e.g., Phase III trials with agents that have a known low-moderate toxicity)
Further elements of risk to consider include: conflict of interest, faculty held IND/IDE, multi-site trial, etc. The Quality Assurance Specialist as an ad hoc member will review each protocol’s DSMP and report to the PRMC on its adequacy.
The PRMC may take one of the following actions on a protocol: approved, approved pending acceptable clarification/revision, re-review required (tabled), or not approved. Action is based on the majority vote of the committee.
Once a protocol is PRMC approved a PRMC approval letter is sent to the Principal Investigator which will be submitted with the WVU IRB submission.