Paragraph 2 The study director’s responsibilities

(1)

The study director has the responsibility for the overall conduct of the safety study and for its report.

(2)

These responsibilities should include, but not be limited to, the following functions—

(a)

agreeing to the study plan;

(b)

ensuring that the procedures specified in the study plan are followed, and that authorisation for any modification is obtained and documented together with the reasons for them;

(c)

ensuring that all data generated are fully documented and recorded;

(d)

signing and dating the final report to indicate acceptance of responsibility for the validity of the data and to confirm compliance with the principles of good laboratory practice;

(e)

ensuring that after termination of the safety study, the study plan, the final report, raw data and supporting material are transferred to the archives.