Good Clinical Practice (GCP) Training and Finding

Where the advertisement for subject recruitment should be filed?

A. The Sponsor file only

B. The investigator file only

C. Both the sponsor and investigator files (where required)

D. Both the sponsor and investigator files and third party (if applicable)

Before the Clinical Phase of the Trial Commences where should the Investigator’s brochure be filed?

A. The Sponsor file only

B. The investigator file only

C. Both the sponsor and investigator files (where required)

D. Both the sponsor and investigator files and third party (if applicable)

Where the sample of labels attached to IMP container should be filed?

A. The Sponsor file only

B. The investigator file only

C. Both the sponsor and investigator files (where required)

D. Both the sponsor and investigator files and third party (if applicable)

GCP Training