Examen
Comparison Between ICH GCP E6 and U.S. FDA Regulations Questions and Answers with complete solution
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CH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they mus - Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulato...
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