[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. If there is no intended clinical benefit to the subject Section 4.8.10(h) requires that the subject be made aware. Consent form should describe the anticipated prorated payments to subjects … 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. FDA regulations do not require that the name and signature of the person obtaining consent be included on an informed consent form and would not generally cite an investigator for not including this on a consent form if the IRB approved form did not contain a signature / date block. Currently we require four signatures : 1) Signature and Date of the Subject /participant. 2) Signature and Date of the Person conducting the discussion or obtaining the consent (performed by qualified personnel) 3) Signature and Date of the Witness (only needed to eye witness the subjects signature ). The signature can be made by anything t...

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