[Answer] Regarding subject signature on consent forms which is true about dates?

Answer: Both FDA and ICH require dates

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Regarding subject signature on consent forms which is true about dates? Regarding subject signature on consent forms which is true about dates ? Both FDA and ICH require dates According to ICH an impartial witness should be present during the entire informed consent discussion when subjects or LARs are unable to read. FDA or ICH : requires the consent form to include a statement that " monitors auditors the IRB/IEC and the regulatory authorities will be granted access to the subject's original medical records for verification of clinical trial procedures and/or data without violating the confidentiality of the subject to the extent permitted by the applicable laws and regulations and that by … The signature of a witness on the standard ( long form ) consent document : A. Is required by federal regulations for research participation B. Indicates that the witness was present during the entire consent conference C. After the written informed consent form and any other written information to be provided to subjects is read and explained to the subject or the subject’s legally acceptable representative and after the subject or the subject’s legally acceptable representative has orally consented to the subject’s participation in the trial and if capable of doing so has signed and personally dated the informed consent form the witness should sign and personally date the consent form . Guidelines for Signatures on Consent Forms These guidelines will assist the Principal Investigator and the team in designing the signature page of the consent form . The ICH Good Clinical Practice: Conso...

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