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  1. Enforcement Activities | FDA

Clinical Investigator Inspection List (CIIL) Database Codes

Database Code Definitions

CIIL Search Page

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
NG Not Given n/a

 * 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

 

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