Bioequivalence and Bioavailability Forum

Dear Vishal,

Have a look at the ICH GCP guideline. Informed consent is described under Investigator's responsibilities (§4.8 and following).

❝ 1) Who is responsible for taking of volunteers informed consent?

§4.8.5: The investigator, or a person designated by the investigator, should fully inform the subject...

Note that the investigator keeps the ultimate responsibility for the informed consent process, even if he delegates the task to another person. I mean that the investigator should ensure that the contents of the ICF document is correct, that the persons who informed the subjects are adequately qualified and trained, that the subjects are given enough time to think, that they can ask questions and get proper answers, that the whole process followed is OK, etc. Task delegation should be done in writing (§4.1.5).

❝ 2) Is there need Principal Investigator (PI) / Clinical Investigator (CI)

❝ Signature in informed consent form (ICF)? or Trained physician signature

❝ is enough instead of PI/CI signature.

§4.8.8: Prior to a subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject [...] and by the person who conducted the informed consent discussion.

Have a look at your National regulations and guideline (see the guidance page) for any specific requirement.

Regards
Ohlbe