- A medically qualified person providing the information, this being the Investigator
- The subject.
- A witness, if this is possible and if required for the study.
A witness is defined as someone who records that the subject has provided consent of their own free will and has been fully informed of the study. The best witness is a subject’s friend or family member who has sat in when the study was being explained to the patient. A witness must have no vested interest in the study; therefore a research assistant/SSC/Sub-Investigator is not suitable as a witness.All signatures should be dated by the person who is signing and under the signature or Sub-Investigator. they should write their name in block capitals.
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