Test facility management has the following responsibilities with respect to a study:

Select one or more options from the list below.

A. ensure documented approval of the study plan by the Study Director

B. ensure that study plans and SOPs are available to study personnel

C. ensure that the Study Director has made the approved study plan available to Quality Assurance personnel

D. ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice

E. ensure that computerised systems used in the study have been validated

F. ensure that the procedures specified in the study plan are followed

G. ensure an individual with the appropriately qualifications, training and experience is designated as the Study Director

H. ensure the designation of the Study Director takes place before the study is initiated