Code
|
Deficiency
|
Code of Federal
Regulations (CFR) Reference
|
00 |
No deficiencies noted |
n/a |
01 |
Records availability |
21 CFR 312.62 |
02 |
Failure to obtain and/or document subject consent |
21 CFR 312.60, 50.20, 50.27 |
03 |
Inadequate informed consent form |
21 CFR 50.25 |
04 |
Inadequate drug accountability |
21 CFR 312.60, 312.62 |
05 |
Failure to follow investigational plan |
21 CFR 312.60 |
06 |
Inadequate and inaccurate records |
21 CFR 312.62 |
07 |
Unapproved concomitant therapy |
21 CFR 312.60 |
08 |
Inappropriate payment to volunteers |
21 CFR 50.20 |
09 |
Unapproved use of drug before IND submission |
21 CFR 312.40(d) |
10 |
Inappropriate delegation of authority |
21 CFR 312.7, 312.61 |
11 |
Inappropriate use/commercialization of IND |
21 CFR 312.7, 312.61 |
12 |
Failure to list additional investigators on 1572 |
21 CFR 312.60 |
13 |
Subjects receiving simultaneous investigational drugs |
21 CFR 312.60 |
14 |
Failure to obtain or document IRB approval |
21 CFR 312.60, 62, 66; 56.103 |
15 |
Failure to notify IRB of changes, failure to submit progress reports |
21 CFR 312.66 |
16 |
Failure to report adverse drug reactions |
21 CFR 312.64, 312.66 |
17 |
Submission of false information |
21 CFR 312.70 |
18 |
Other |
n/a |
19* |
Failure to supervise or personally conduct the clinical investigation |
21 CFR 312.60 |
20* |
Failure to protect the rights, safety, and welfare of subjects |
21 CFR 312.60 |
21* |
Failure to permit FDA access to records |
21 CFR 312.68 |