Question

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:____________.

Answer 1

Answer:

They must disclose that they are entitled to having access to the medical record of the subject. This is usually disclosed in the form of an informed consent that provides access to the auditor, monitor, regulatory authorities and IRB/IEC. This is usually for verification purposes of the data and procedures used in the research. No confidentiality or data violation issues outside the law may arise by this consent.

Explanation: