GCRC
Research Subject Advocate (RSA)
The
GCRC RSA program is committed to facilitate the new patient and
safety monitoring process for investigators. The RSA, the IRB, the
GAC, and the PI (who has primary responsibility), are responsible
for ensuring that all studies conducted on the GCRC meet the safety
requirements. Specifically, the RSA is responsible for the following:
- To
ensure adequacy of the patient safety moitoiring plans (PSMPs),
which may include data safety monitoring board (DSMB) if required
by an NIH Institute or GCRC Advisory Committee (GAC);
- To
facilitate Principal Investigators' reporting of adverse events;
- To
serve as a source of information for research subjects, investigators,
nurses, study coordinators and other key study personnel.
- To
serve as unbiased observer and counsel to potential subjects and
research teams on informed consent
This
level of oversight is necessary to assess compliance of clinical
protocols as it relates to subject safety throughout the conduct
of the trial.
Additional
Food & Drug Administration (FDA) and National Institutes of
Health (NIH) scrutiny applies to any clinical study at Georgetown
University, whether or not the study is performed on the GCRC. All
investigators are responsible for meeting safety requirements with
or without the help of the RSA. The RSA program is designed to help
the investigators and to make it easier for them to be in compliance.
This program is a unique opportunity to provide GCRC investigators
and personnel with the education and guidance to prepare protocols
and consent forms, to prepare investigators for mandatory audits,
and to ensure compliance with safety regulations.
Investigators
are encouraged to contact Judith Baigis, RSA of Georgetown University
GCRC at baigisj@georgetown.edu
or 202.687.5127 before submitting a protocol to ensure that they
have captured the key elements of the NIH's new safety requirements.
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