RESEARCH SUBJECT SAFETY OFFICE
The CRC Research Subject Safety Office (RSSO) provides the role of Research Subject Advocate (RSA). The RSA role is to facilitate research subject safety protection and to ensure that research in the
CRC is conducted in compliance with federal requirements and in accordance with the CCI and CRC approved protocol.
The BIDMC RSSO is staffed with a Director, Research Nurse and Research Assistant. The
CRC satellites at the Joslin Diabetes Center and the Forsyth Institute also have Research Subject Advocates as part of the RSSO.
Examples of responsibilities of the CRC Research Subject Safety Office include:
1)
Assuring that CRC studies are performed according to the approved protocol
2)
Providing education to CRC staff, investigators and research participants
3)
Monitoring of the informed consent process
4)
Assisting CRC Investigators in formulating data safety monitoring plans (DSMPs)
All BIDMC and CRC research protocols must include a Data Safety Monitoring Plan (DSMP). As part of both the CCI application and
CRC application Part P must be completed. Joslin and Forsyth protocols being submitted to the CRC must also include this DSMP. In completing the DSMP, investigators are required to assess the risk level of the protocol using the definitions and examples provided as guidance. The planned procedure for safety monitoring must be detailed and clear in the submitted protocol description and/or in additional information provided in the DSMP. The RSSO is available to work with
CRC investigators in developing DSMP’s. Once submitted, the RSSO and CRC Scientific Advisory Committee will also assess the risk level of the study and, when appropriate, may require and will assist investigators in modifying the DSMP according to this assessment.
Further information re: DSMP's and Part P can be found at the BIDMC CCI website.
For more
information please contact
Director, RSSO
Steven Schachter, MD
617-667-4460; 617-667-1764; Fax: 617-667-5953
E-mail:
sschacht@bidmc.harvard.edu
Research Nurse, RSSO
Nancy Brown, RN
617-667-0332; Fax: 617-667-5953
E-mail: nbrown@bidmc.harvard.edu
The
Harvard-Thorndike CRC is funded by Grant M01 RR01032 from the NCRR, NIH
Please send general questions about
the CRC to the
Administrative Manager.
Technical questions about this Web site can be addressed to the GCRC's
Webmaster.
Clinical Research Center
(CRC)
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
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