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.
In order to discuss and produce ICH recommendations, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory agencies and the pharmaceutical sector. Beyond the membership and regional representation of ICH itself, the ICH E6 Good Clinical Practice (GCP) Guideline is extensively used by clinical trial researchers and has a substantial effect on trial participants and patients.
The ICH E6 guidelines do not have the force of law in the U.S. and are not regulations.
Learn more about ICH E6 here:
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