Question

The new ICH E6(R2) integrated addendum 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 _________.

Answer 1

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

Explanation:

 The ICH E6 basically uses the system that uses the risk based approach that include the identification of the risks of study that basically determine the continual monitoring safely.

The ICH met a specialist working gathering to make an addendum to the current E6 rule. The master  working gathering was comprised of ICH individuals from both industry and administrative offices, just as  observers to address and flow examine themes like quality by plan, quality hazard the board