COMPARISON
BETWEEN ICH GCP E6
AND U.S. FDA
REGULATIONS
ICH E6 has broader re- quirements than FDA or HHS
concerning confiden- tiality of medical records and
access by third par- ties. If investigators are
complying with ICH E6 guideline, they mus
The new ICH E6(R2) integrated addendum re- quires
sponsors to im- plement systems to man- age quality
throughout all stages of the trial process.
The system should use
a risk-based approach in- cluding which of the follow-
ing?
In terms of explaining the probability of assignment to
trial arms in consent forms, which is true?
What is the status of ICH in U.S.?
BETWEEN ICH GCP E6
AND U.S. FDA
REGULATIONS
ICH E6 has broader re- quirements than FDA or HHS
concerning confiden- tiality of medical records and
access by third par- ties. If investigators are
complying with ICH E6 guideline, they mus
The new ICH E6(R2) integrated addendum re- quires
sponsors to im- plement systems to man- age quality
throughout all stages of the trial process.
The system should use
a risk-based approach in- cluding which of the follow-
ing?
In terms of explaining the probability of assignment to
trial arms in consent forms, which is true?
What is the status of ICH in U.S.?
