Bioequivalence and Bioavailability Forum

❝ Is it necessary to distribute a copy of signed informed consen to the volunteer who is not entered into the study? i.e If the subject not meeting the inclusion criteria at check-in level, after signing of informed consent.

It is of utmost importance to give the copy of ICD to the volunteer before starting the ICF presentation. This is in complete compliance with 11 principles laid down in 21-CFR-50, ICH-GCP-Topic E 6 - Step 5, 4.8.11 and bioethical guidelines by ICMR. Also part 42 - right to information act- following this law, you have to give complete information to the volunteer before extracting any consent for any procedure you may have designed. Also, make sure to have your IEC invited during any of the ICF presentation and let them document the same with a precise point that you gave a copy of the ICD to the volunteer. The FDA off late is very keen to know these details.