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 AAHRPP Accredited
RCRC Independent Review Board, LLC is proud to announce Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
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New FDA Regulation
In compliance with new FDA regulation 21 CFR 56.106, RCRC is registered with the Department of Health and Human Services. The registration also satisfies the registration requirement for OHRP as the two agencies currently use the same electronic registration system.
IRB registration numbers are:
Board 1 registration number IRB00006833
Board 2 registration number IRB00006834
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Safety Reporting Including Unanticipated Problems
There are two types of safety reporting Investigators and Research Staff should be concerned with -- Safety Reports (SAEs, IND Safety Reports/Unanticipated Adverse Device Effects) and Unanticipated Problems.
RCRC has established the following definitions:
Unanticipated Problems - An event or discovery of new information that is unanticipated, potentially increases risk to one or more research participants or others, and is related to the research.
Safety Reports - internal (site-specific) or external adverse events which are (1) serious, (2) unexpected and (3) related to the study product.
RCRC requires reporting within 10 business days of the Investigator learning of the event.
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RCRC is committed to service excellence and the highest standard of ethical review.
Please contact our office if we can provide you with additional information.
Regards,
Priscilla Short, CIM, CIP, CCRP
Executive Director
512.380.1244
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