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2According to GCP and CFR regulations, documentation of informed consent include which of the follow?
A. The IRB must approve the consent form.
B. The participant or the participant's legally authorized representative must sign the current version of the IRB approved consent form.
C. A copy must be given to the person that signs it.
D. All of the above.

Respuesta :

According to the GCP and CFR regulations, documentation of informed consent include all of the above . D

GCP and CFR informed consent regulations

  • The investigator should have the IRB/IEC's written approval opinion of the written informed consent form
  • The written informed consent form and any other written information to be provided to subjects should be well revised
  • Any revised written informed consent form, and written information should receive the IRB/IEC's approval opinion in advance.
  • The subject or the subject’s legally acceptable representative should be informed in time.
  • None of the oral and written information concerning the trial should contain any language that confuses the subject or is not acceptable by the subject

Thus, according to the GCP and CFR regulations, documentation of informed consent include all of the above . D

Learn more about informed consent here:

https://brainly.com/question/20329514

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