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Role of the RSA
The primary role of the RSA is to ensure that all
studies conducted on the GCRC,
are designed and conducted safely and ethically with protection
of human subjects accorded the highest priority.
RSA Activities
- assist GCRC investigators to formulate Data Safety Monitoring Plans
(DSMP)
- evaluate adequacy of DSMRs submitted by investigators
- ensure that DSMPs are fully implemented as
reflected in the Data and Safety Monitoring Report (DSMR)
- review submitted protocols for potential risks and
benefits, complexity and adequacy of proposed safeguards
- review consent forms for consistency with protocol,
readability, completeness
- assure that GCRC studies are conducted according the
IRB approved version of the protocol
- assist investigators
with submission of serious adverse events to all required
parties, such as the IBRA, FDA,
and study sponsor
- provide education and training in human subjects protection
and the conduct of clinical research studies to investigators
and their study staff
- serve as an unbiased witness in the informed
consent process when requested
- conduct study audits “for cause” and “not for
cause ”
- serve as advocate for research subjects by:
- helping subjects understand clinical research and the role they
play
- assisting in resolution of conflict or concerns between research
subjects or their representatives and research staff
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