Strengthen Your Trial Before Activation
Successful clinical trials require more than an important research question. Studies must be scientifically rigorous, operationally feasible, and positioned for successful accrual and completion.
Through scientific review and ongoing oversight, the Protocol Review & Monitoring Committee (PRMC) works with you to refine your protocol before activation through multidisciplinary scientific feedback focused on study design, feasibility, accrual potential, and overall study performance.
PRMC Review Requirements
All prospective cancer-related research projects conducted at Case Western Reserve University, Cleveland Clinic, or University Hospitals Cleveland Medical Center must submit to the PRMC for scientific review and approval before initiation.
PRMC oversight applies to all prospective research, including but not limited to:
Interventional Studies: Clinical trials or projects evaluating the safety, efficacy, or outcomes of a specific intervention. Examples include clinical trials testing new drugs, novel surgical techniques, radiation therapy regimens, behavioral interventions, or diagnostic devices.
Observational Studies: Research that gathers data on subjects without active investigator intervention. Examples include prospective cohort studies tracking patient outcomes, longitudinal quality-of-life surveys, biobanking registries, and non-interventional screening studies.
Basic Science & Correlative Studies: Lab-based or translational research linked to clinical data or human specimens. Examples include projects analyzing patient tumor tissue for biomarkers, genomic sequencing studies on patient blood samples, or laboratory experiments investigating mechanisms of therapeutic resistance using patient-derived models.
Unsure if your study requires review? Please contact prmc@case.edu for further guidance.
How the PRMC Supports Investigators
The PRMC reviews studies to help ensure they:
- Address important scientific and clinical questions
- Are designed to produce meaningful and impactful results
- Are feasible within available patient populations and institutional resources
- Complement ongoing research efforts across the consortium
- Maintain scientific progress throughout the life of the study
Early scientific review can help investigators identify potential challenges before activation, strengthen protocol design, and improve study readiness.
Ongoing Study Monitoring
The PRMC also monitors active studies for accrual, scientific progress, and overall study performance. Ongoing oversight helps identify enrollment barriers, support effective study execution, and promote responsible use of research resources.
As an NCI-required component of comprehensive cancer centers, the PRMC helps support the quality, integrity, and impact of cancer clinical research across the consortium.
About Case CCC PRMC
Submission & Review Process
Policies & Guidelines
Protocol & Review Form Templates
- Protocol Templates
- Primary Review
- Statistical Review
- Pharmacy Review
- Clinical Review
- Patient Advocate Review
- Population Science Review
- Behavioral Health Review
- Correlative Science Review
Contact
Email PRMC@case.edu for further information.