_dta: 1. cliil set up by Jean Roth , jroth@nber.org , 8 Feb 2017 2. NBER URL: http://www.nber.org/data/fda-clinical-investigator-inspection-list-cliil-data.html 3. Source Page: http://www.fda.gov/Drugs/InformationOnDrugs/ucm135198.htm 4. Source File URL: www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM111343.zip location: 1. NG denotes Not Given. address: 1. If a clinical investigator does not have a study or business site given, it will be the home address. 2. NG denotes Not Given. obs: 20,083 vars: 16 8 Feb 2017 11:57 size: 5,221,580 (_dta has notes) ------------------------------------------------------------------------------------------------------------------------------------------------------------ storage display value variable name type format label variable label ------------------------------------------------------------------------------------------------------------------------------------------------------------ nvn str20 %20s A 6 digit computer number unique to the clinical investigator. lastname str24 %24s The last name of the clinical investigator firstname str14 %14s The first name of the clinical investigator location str106 %106s * The location of the business of the investigator. NG denotes Not Given. address str37 %37s * The address of the site named above city str15 %15s The city location of the address state str2 %9s The 2 letter state code country str3 %9s The 2 letter country code. zipcode str9 %9s The zip code for the address inspdate float %td The initial start date of the Inspection inspdatestr str10 %10s The initial start date of the Inspection. String classtype float %15.0g classtype Classification Type classtypestr str2 %9s Classification Type String classcode float %200.0f classcode Classification Code classcodestr str5 %9s Classification Code String defcode byte %88.0g defcode The description of the inspection deficiency * indicated variables have notes ------------------------------------------------------------------------------------------------------------------------------------------------------------ Sorted by: nvn nvn lastname firstname location address city state country zipcode inspdate inspdatestr classtype classtypestr classcode class > codestr defcode classtype: 401 DA - Data Audit 603 FC - For Cause 1520 OT - Other classcode: 15923 OAIW - Warning letter issued 132006 MTF - Case closed with a Memo to File 140109 NAI - No Action Indicated. No objectionable conditions or practices were found during the inspection. 150109 OAI - Official Action Indicated. Objectionable conditions were found and regulatory and/or administrative sanctions by FDA are indicated. 150903 OAIC - Completed 150918 OAIR - Response requested 180506 REF - Reference 220109 VAI - Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any correctiv > e action is left to the investigator to take voluntarily. 220918 VAIR - 30-day response requested 220939 VAI3F - Follow-up for cause inspection issued 1091803 VAIRC - 30-day response requested and case closed 1091818 VAIRR - 30-day response requested, received and accepted 1509182 OAIRR - Response requested and accepted 1592318 OAIWR 2201091 VAI1 - Correction made on site 2201092 VAI2 - No response requested 2201093 VAI3 - Response requested 2201095 VAI2C - Consent problems found 2201096 VAI3C - Case closed 2219318 VAI3R - Response received and accepted 2311908 WASH - Washout. An inspection was initiated but no meaningful information could be obtained. 3011403 CANC - Cancelled. The inspection assignment was canceled before the inspection was started. defcode: 0 None 1 Problems with records availability 21 CFR 312.62 2 Failure to obtain patient consent 21 CFR 312.60, 50.20, 50.27 3 Inadequate patient consent form 21 CFR 50.25 4 Inadequate drug accountability 21 CFR 312.60, 312.62 5 Failure to adhere to protocol 21 CFR 312.60 6 Inadequate and incorrect records 21 CFR 312.62 7 Unapproved commitment therapy 21 CFR 312.60 8 Inappropriate payment to volunteers 21 CFR 50.20 9 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 Patients receiving simultaneous investigational drugs 21 CFR 312.60 14 Failure to obtain or document IRB approval if necessary 21 CFR 312.60, 62, 66; 56.103 15 Failure to notify IRB of changes, failure to submit progress reports, etc. 21 CFR 312.66 16 Failure to report adverse reactions 21 CFR 312.64, 312.66 17 Submission of false information 21 CFR 312.70 18 Other 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