Clinical Research Support

Protocol Revisions

FHCRC/Cancer Consortium Institutional Review Office (IRO) Procedures for Protocol Modifications:

Clinical Research Support and Protocol Revisions

Clinical Research Support involvement in study modification varies depending on the type of study. For some studies, the Protocol Review Coordinators provide document version control and SRC review followed by IRB submission. For others, Clinical Research Support may only provide Scientific Review. Email submissions@fhcrc.org for more detailed information.

ClinicalTrials.gov and NCI's Clinical Trials Reporting Program (CTRP)

Depending on the type of study, CRS may submit amendments to NCI's CTRP and process the corresponding updates on ClinicalTrials.gov. You can find more detailed information here.

External Performance Site Assessment Committee (EPSAC) Review when Adding Sites

If a current or future multi-site trial is conducted by a Consortium investigator also holding the IND, EPSAC review may be necessary before modifications to add sites can move forward. Contact Clinical Research Support for more information or learn more about EPSAC here.

SRC Review of Major Changes

If a study is subject to Scientific Review, regardless of the IRB of record, major modifications to the protocol need to be reviewed by the Scientific Review Committee that originally reviewed and approved the study. Revisions are sent first to a biostatistician and a representative of the Scientific Review Committee for sign-off. Based on their review, the revision could be referred to the full Scientific Review Committee for approval. Final Scientific Review Committee approval documentation is then submitted with the revision to the IRB of record.

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