The Protocol Review and Monitoring System (PRMS) ensures adequate internal oversight of the scientific aspects of all cancer clinical trials conducted at the Stephenson Cancer Center. PRMS review focuses on scientific merit, study prioritization, data integrity, scientific relevancy, inclusion of underrepresented populations, and accrual progress.
Review and monitoring of new and ongoing clinical trial protocols occurs in two stages:
Stage One: Disease Groups comprised of physicians, nurses, pharmacists and investigators
representing specific disease-site cancers (e.g., breast, urologic, lung,
etc.) review all new clinical trial protocols to assess scientific merit,
applicability to current and underrepresented patient populations, overlap
with potentially competing trials, and whether the protocol aligns with
Disease Group goals. Disease Groups also conduct continuing review of
open protocols in their area, focusing on accrual progress, new safety
information, and continuing scientific relevancy, to help ensure timely
completion of the study.
Stage Two: The Protocol Review and Monitoring Committee (PRMC) – which is comprised
of faculty representing basic laboratory, clinical, behavioral, biostatistical,
and population science – conducts an independent review of all new
protocols to evaluate scientific merit, statistical validity, design feasibility,
inclusion of underrepresented populations, and study prioritization. The
PRMC will refer protocols that need further development back to the appropriate
Disease Group, along with recommendations for enhancing protocol design.
All new clinical trial protocols must have PRMC approval before proceeding
to the Institutional Review Board (IRB). In addition, the PRMC is responsible
for conducting continuing review of open protocols, focusing on accrual
progress, new safety information, and continuing scientific relevancy,
to help ensure timely completion of the study. The cancer center director
has delegated to the PRMC the sole authority to authorize activation and
termination of clinical trials at the Stephenson.
The following form should be included with any new protocol submission
to the Protocol Review and Monitoring Committee.
PRMC Submission Form
Please also include with the submission a copy of the protocol, any additional
grant or budget information that may be available (for investigator-initiated
projects) and a copy of the consent or HIPAA.
Protocol Review Timeline and Deadlines
New submissions can be sent electronically as attachments to the Protocol Review and Monitoring Committee Coordinator at scc-prmc@ouhsc.edu.
If you wish to contact the committee coordinator with additional questions, please call 405-271-8001 x48474.