Bioequivalence and Bioavailability Forum

❝ It is highly recommended to include all the adverse events in the ICF even though they were observed in the Clinical Trials as mentioned in the product monograph. If you mention only the most common adverse events in the ICF, the Ethics committee may raise concern that you are not revealing all possible side effects to the study participants.

Dear Sir,

Thanks for your kind reply.

As per FDA guidance "A Guide to Informed Consent - Information Sheet
Guidance for Institutional Review Boards and Clinical Investigators
Contents" http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm
"The risks of procedures relating solely to research should be explained in the consent document. The risks of the tests required in the study protocol should be explained, especially for tests that carry significant risk of morbidity/mortality themselves. The explanation of risks should be reasonable and should not minimize reported adverse effects.
The explanation of risks of the test article should be based upon information presented in documents such as the protocol and/or investigator's brochure, package labeling, and previous research study reports. For IND studies, the IRB should assure that the clinical investigator submits the investigator's brochure (when one exists) with the other study materials for review."


it means that the risk involved only after single dose shall be included. does it?

Regards,

Prashant Nikam