Informed Consent
The IRB must approve the informed consent prior to study initiation and often the CRC is liaison between the IRB and the sponsor. The sponsor will have set requirements of the informed consent as does the IRB. Each local IRB is responsible for the review and approval of the informed consent, but the CRC is responsible for the communication between the IRB and the sponsor. ยง46.116 of the Code of Federal Regulations outlines the elements of informed consent as:
Read more about this topic: Clinical Research Coordinator, Responsibilities
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