Research at Fox Chase »Research Facilities »Clinical Research Facilities

Staff

Function

The Research Review Committee (RRC) provides the primary mechanism for scientific evaluation of new and ongoing clinical research protocols, and has the authority to activate and close all clinical studies in conjunction with the Institutional Review Board (IRB). Administrative support for RRC is coordinated through the Protocol Management Office. Early interaction between investigators and the Protocol Office facilitates staff assignments, consideration of resource utilization, and review of operational details for each new study. In addition to the primary committee membership, the overall Protocol Review and Monitoring System is enhanced by formal and informal interactions with other Center resources and facilities, including clinical departments, disease-specific clinical programs, the developmental therapeutics program, investigational pharmacy, and laboratory research programs. RRC maintains a multidisciplinary membership selected from the scientific, clinical and biostatistical staff at Fox Chase to ensure adequate review of diverse clinical research studies.

Description

Prior to submission to the RRC, a concept sheet is developed by the principal investigator. Based on input from colleagues, including support from the Biostatistics Facility, the protocol is then developed and re-circulated for additional comments and departmental approval. To be eligible for RRC evaluation, the protocol must be complete and in reviewable format. The biostatistical section must be complete, and all investigator-initiated studies require the participation of a biostatistician as co-investigator. The RRC, if needed, meets on a weekly basis so that recommendations for changes can be made in a timely manner. A protocol may be approved without changes, approved with minor changes, or disapproved, requiring re-submission to the RRC after changes have been made. Review and approval of the statistical methods is a mandatory element of this process. Once a protocol is approved by the RRC, it is placed on the monthly IRB agenda.

Additional information and forms can be obtained through the Protocol Information Management web site.