Clinical Investigator Inspection List (CIIL) Database Codes

Database Code Definitions

The following codes occur in the CLIIL database: Classification, Deficiency, and Inspection Type. Some codes are no longer being used, but they still appear in the database.

Classification Codes

MTF - Case closed with a Memo to File
NAI - No Action Indicated. No objectionable conditions or practices were found during the inspection.
VAI - Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily.
- VAI1 - Correction made on site
- VAI2 - No response requested
- VAI2C - Consent problems found
- VAI3 - Response requested
- VAI3C - Case closed
- VAI3F - Follow-up for cause inspection issued
- VAI3R - Response received and accepted
- VAIRC - 30-day response requested and case closed
- VAIRR - 30-day response requested, received and accepted
- VAIR - 30-day response requested
OAI - Official Action Indicated. Objectionable conditions were found and regulatory and/or administrative sanctions by FDA are indicated.
- OAIC - Completed
- OAIR - Response requested
- OAIRR - Response requested and accepted
- OAIW - Warning letter issued
CANC - Cancelled. The inspection assignment was canceled before the inspection was started.
WASH - Washout. An inspection was initiated but no meaningful information could be obtained.
REF - Reference

Deficiency Codes

CLIIL Deficiency Codes

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

* Codes 19, 20, and 21 became effective October 1, 2005.

Inspection Type Codes

DA - Data Audit: An inspection in which the focus is on verification of study data.
FC - For Cause: An inspection in which the focus is on the conduct of the study by the Clinical Investigator.
IG - Information Gathering