If there is any deviation from the study plan

Select one or more options from the list below.

A. It should be documented and communicated directly to the Study Director

B. The impact on the quality and integrity of the study should be assessed and documented by the Study Director

C. It should be documented and communicated to test facility management

D. The Study Director should take appropriate corrective action if necessary

E. It should be documented and communicated to Quality Assurance personnel