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INFORMED CONSENT SOURCE DOCUMENTSubjects Initials: Subject Number: Protocol Number: Date and time consent obtained: Name of person who explained study: THE CONSENT PROCESS IS NOT COMPLETE UNTIL ALL

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What is informed consent source document?

The informed consent source document is a document outlining the details and purpose of a medical procedure or research study, which a patient or study participant must sign to indicate their understanding and agreement to participate.

Who is required to file informed consent source document?

Healthcare providers conducting medical procedures or researchers conducting research studies involving human subjects are required to file informed consent source documents.

How to fill out informed consent source document?

The informed consent source document is typically filled out by the healthcare provider or researcher, and then presented to the patient or study participant for review and signature.

What is the purpose of informed consent source document?

The purpose of the informed consent source document is to ensure that individuals are fully informed about the risks and benefits of a medical procedure or research study, and freely consent to participate.

What information must be reported on informed consent source document?

The informed consent source document must include details about the procedure or study, potential risks and benefits, alternatives, confidentiality, and the right to withdraw consent at any time.

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