Ich 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 must:

They must obtain the informed consent of the subject which grant them direct access to the subject's original medical records for verification of medical trial procedure and/ or data without violating the confidentiality of the subject to the extent permitted by relevant law and regulations.

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jamuuj jamuuj · Answer 2 · 2018-07-07T11:52:54+02:00

Answer;
if investigators are complying with ICH E6 guideline, they must clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records.

Explanation;
The FDA regulations allow subjects or the legally acceptable representatives to receive either a signed or unsigned copy. Therefore, they must obtain the informed consent of the subject which grant them direct access to the subject's original medical records for verification of medical trial procedure and/ or data without violating the confidentiality of the subject to the extent permitted by relevant law and regulations