Research Subject Advocate Program
The Research Subjects Advocate (RSA) program is designed to ensure the safety of people who
enroll in research studies performed on the GCRC. We serve as a resource for investigators
as well as for study participants.
A Resource for Investigators
We help investigators create and implement Data
and Safety Monitoring Plans (DSMP) — detailed procedures for how the study will be
monitored to assure continued safety of the participants and the integrity of the data
collected. We also review the human subjects and DSMP components of all applications
to the GCRC. Once applications are approved, we work with investigators to make certain that
studies are conducted according to plan and in the safest manner possible.
All applications to the GCRC require a DSMP.
 For
assistance with a DSMP, please email or call us early in the development of your protocol. We
encourage you to take advantage of the GCRC's other available consultations
as well.
We provide ongoing education
to investigators and research staff about regulatory compliance, informed consent,
Good
Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice
(GMP) as appropriate.
A Resource for Study Participants
We are happy to respond to general questions from people who are considering enrolling in a
clinical trial at the GCRC or those who have already enrolled. At the request of the
investigator or participant, we are available to observe the informed consent conference.
Please call or email us using the contact information listed in the Quick Help box above.
More
information for Study Participants.
Independent Oversight
Studies conducted through the GCRC are monitored commensurate with the risks posed by each
protocol. We verify that various aspects of the SAC approved protocol are functioning as
proposed: informed consent, eligibility review, and compliance to the approved DSMP. We also
monitor that adverse events are reported by the PI to the study sponsor, the GCRC , the FDA
and the Institutional Review Board as indicated.
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