Essential documents after completion or termination of the trial

Question 1

INVESTIGATIONAL PRODUCT(S)
ACCOUNTABILITY AT SITE

Answer 1

Located in the files of
1. Investigator
2: sponsor

Question 2

DOCUMENTATION OF
INVESTIGATIONAL PRODUCT
DESTRUCTION

Answer 2

Located in the files of
1. Investigator (if destroyed by site)
2: sponsor

Question 3

COMPLETED SUBJECT
IDENTIFICATION CODE LIST

Answer 3

Located in the files of
1. Investigator

Question 4

AUDIT CERTIFICATE (if available)

Answer 4

Located in the files of
1. sponsor

Question 5

FINAL TRIAL CLOSE-OUT
MONITORING REPORT

Answer 5

Located in the files of
1. sponsor

Question 6

TREATMENT ALLOCATION AND
DECODING DOCUMENTATION

Answer 6

Located in the files of
1. sponsor

Question 7

FINAL REPORT BY INVESTIGATOR
TO IRB/IEC WHERE REQUIRED,
AND WHERE APPLICABLE, TO THE
REGULATORY AUTHORITY(IES)

Answer 7

Located in the files of
1. Investigator

Question 8

CLINICAL STUDY REPORT

Answer 8

Located in the files of
1. Investigator
2: sponsor