Bioequivalence and Bioavailability Forum

Dear Sri,

❝ I have a small doubt regarding the informed consent form used in clinical trails prior to screening tests. That is whether the leagally accepted representative who signed in others informed consent can participate in the same study as another volunteer?

❝

❝ Please clarify my doubt as early as possible.

Yes, ICH-GCP does not specify to exclude LAR

But you can not include impartial witness in a clinical trail, where he/she given consent as a impartial witness

Regards

Raghavender Chenna