Essential Documents - Sponsor vs. Investigator Flashcards
1
Q
Advertisement for subject recruitment
A
INVESTIGATOR ONLY
2
Q
Agreement between Investigator & Authorities
A
INVESTIGATOR ONLY
3
Q
Signed ICF
A
INVESTIGATOR ONLY
4
Q
Source docs
A
INVESTIGATOR ONLY
5
Q
Copy of CRFs & CRF corrections
A
INVESTIGATOR ONLY
6
Q
Subject ID code list
A
INVESTIGATOR ONLY
7
Q
Subject enrollment log
A
INVESTIGATOR ONLY
8
Q
IP destruction doc (if destroyed on site)
A
INVESTIGATOR ONLY
9
Q
COMPLETED subject ID code list
A
INVESTIGATOR ONLY
10
Q
Final report by investigator to IRB
A
INVESTIGATOR ONLY
11
Q
Clinical Study Report (trial results, if applicable)
A
INVESTIGATOR ONLY
12
Q
IP sample labels
A
SPONSOR ONLY
13
Q
Certificate of Analysis for IP (documents strength & purity of IP)
A
SPONSOR ONLY
14
Q
Master Rando List
A
SPONSOR ONLY
15
Q
Pre-trial monitoring report
A
SPONSOR ONLY
