NIMH Clinical Research Education, Support, and Training (CREST) Program

Purpose:

The NIMH Clinical Research Education, Support, and Training (CREST) Program provides ongoing educational and technical support from NIMH staff for clinical research project grants which are selected for consultation and/or site visit(s). The CREST Program aims to ensure that the reported clinical research study data are accurate, complete, and verifiable; the conduct of the study is in compliance with NIH/NIMH policies and procedures, the regulations of applicable agencies, the study protocol, and applicable Good Clinical Practice (GCP) guidelines; and the rights and well-being of human subjects are protected, in accordance with 45 CFR 46 (Protection of Human Subjects) and, as applicable, 21 CFR part 50 (Protection of Human Subjects).

Process:

To promote clinical research that is compliant with human subjects regulations and applicable GCP guidelines, the CREST Program includes consultation and/or site visit(s) from NIMH staff, as needed, to assess and provide written feedback and recommendations on planned or ongoing clinical research protocols. Documents relating to the conduct of the clinical research, such as current IRB approved protocols, informed consent documents, source documents, and drug accountability records, as applicable, may be reviewed for compliance with applicable Federal regulations, policies and guidance, and institutional and IRB policies.

Research project grants selected for inclusion in the CREST Program might include, clinical research studies with “significantly-greater-than-minimal risk” to subjects (e.g., an intervention or invasive procedure with high potential for serious adverse events; see NIMH Risk-Based Monitoring Guidance); a study intervention under an FDA Investigational New Drug or Investigational Device Exemption; or other studies identified by NIMH staff that may benefit from inclusion in CREST. CREST is separate and distinct from “for cause” audits of clinical research. Research grants may be included in CREST at any time during the grant lifecycle, although, generally, grants are identified and selected for the program at the initiation of the grant.

For more information on CREST, please contact Sharon Smith at smiths@mail.nih.gov