Supplement to CRC Data and Safety
Monitoring Plan Guidelines
SUPPLEMENT TO DSMP GUIDELINES, ITEM 4, REPORTING PLANS
Adverse Event Reporting
Unexpected AE Reports:
To CRC Scientific Advisory Committee,
CRC Program
Director, and RSA within 10 days.
Serious AE (SAE) Reports:
Verbally to CRC Program Director and RSA verbally within 24 hours.
In writing to CRC Program Director and RSA in 48 hours. (If serious and unanticipated AE reported to HRAC, can
be copy of form used to report SAE to HRAC.)
In accordance with HRAC IRB Handbook
for Investigators Conducting Human Research Studies for reporting of
serious and unanticipated AEs.
In accordance with
reporting requirements of NIH or other appropriate funding or regulatory
agencies.
General reporting
of AEs:
A copy of all AE reports to HRAC to the
RSA, preferably in electronic form. 
