Last Updated on February 22, 2022
The Principal Investigator shall report any Adverse Events associated with the Clinical trials to the sponsor, IRB / IRCs and the DRAP.
Sponsor shall bound the investigator to report all serious adverse events immediately to him except for those that the protocol or investigator’s brochure identifies as not requiring immediate reporting. Adverse events and laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol.
Serious Adverse Events associated with a clinical trials shall be reported to the DRAP using our online report system.