comparison b/t ich gcp e6 and us fda regulations

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:

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 terms of explaining the probability of assignment to trial arms in consent forms, which is true?

ICH notes that it should be included, but does not specify how the information should be presented.

The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following?

Identification of study risks to determine which may safely be omitted from continual monitoring

What is the status of ICH in U.S.?

It is a FDA guidance.

Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA regulations?

The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy