External Performance Site Assessment Committee
Members and Objectives
To aid Cancer Consortium Principal Investigators and/or Cancer Consortium IND/IDE sponsors in assuring compliance with CFR 21 Part 312.50, the External Performance Site Assessment Committee (EPSAC), consisting of individuals from Clinical Research Support, Regulatory Affairs, with advisors from the Office of General Counsel at the FHCRC, will assess external performance site(s) for adequacy to perform study requirements and the Cancer Consortium PI’s plan as a coordinating center investigator.
Studies Reviewed by the EPSAC
Only Cancer Consortium investigator-initiated, multi-center studies under an IND/IDE, for which a Cancer Consortium investigator is the IND/IDE sponsor, need review by the EPSAC. Types of submissions should include:
- New studies
- Modifications to existing studies changing from single-center to multi-center
- Modifications to existing studies adding external performance site(s)
Studies and Performance Sites Not Reviewed by the EPSAC
- Multi-center studies without an IND/IDE
- Multi-center studies with an IND/IDE held by a non-Cancer Consortium IND/IDE sponsor
- Single-center IND/IDE studies
- Performance sites within the Cancer Consortium do not need EPSAC review (FHCRC, UW, SCCA and Seattle Children’s).
External Performance Site(s) Reviewed by the EPSAC
Examples of external performance sites to be reviewed include but are not limited to the following:
- Oregon Health Science University (OHSU)
- Stanford University
- MD Anderson Cancer Center
- City of Hope National Medical Center
- St. Joseph’s Hospital
- Olympic Medical Center
Areas of Committee Assessment
Committee assessment of the external performance site involves the following areas:
- Site PI clinical trial experience
- Site PI IND/IDE experience
- Qualifications of the research staff
- Pharmacy or Production support
Committee assessment of the Cancer Consortium Principal Investigator’s plan as a coordinating center includes the following areas:
- Monitoring plan for external performance sites
- CRF development and data QA process
- Training for the external performance site
Required Documentation with Submission to the EPSAC
All submissions to the committee must include the External Performance Site Feasibility Checklist and an external site specific Data Safety Monitoring Plan.
Additional documentation required will be dependent on the type of submission for Committee review. The Committee Coordinator will work with you to assist you with your submission(s).
For submission and/or committee questions, contact the Committee Coordinator, Leslie Woestenborg, via email or at 206-667-1165.