Preparing a clinical site for a clinical investigator inspection by the FDA

Drug Information Journal

Volumn 33, Issue 1, 1999, Pages 253-259

  Curran, Charles F ^a,b  

^a FOREST RESEARCH INSTITUTE   (United States)

^b Forest Pharmaceuticals Inc   (United States)

Author keywords

Clinical investigators; Compliance; FDA; Inspections

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; PLANNING; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL;

EID: 0033004876     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159903300128     Document Type: Article

References (13)

1. FDA Inspections of Clinical Investigators, http:// www.fda.gov/oha/IRB/inspect.html, June 1, 1998.
2. Compliance Program Guidance Manual. Chapter 48 - Bioresearch Monitoring - Human Drugs. Washington, DC; Food and Drug Administration; September 1, 1994.
3. Bruckheimer M. PDA's inspections of clinical investigators. Drug Inf J. 1993;27:213-216.
4. Informed Consent and the Clinical Investigator. http://www.fda.gov.oha/IRB/informed.html, June 1, 1998.
5. Title 21 Code of Federal Regulations. 312.52. Washington, DC: U.S. Government Printing Office; 1997.
6. Title 21 Code of Federal Regulations. 312.56. Washington, DC: U.S. Government Printing Office; 1997.
7. Title 21 Code of Federal Regulations. 312.66. Washington, DC: U.S. Government Printing Office; 1997.
8. Title 21 Code of Federal Regulations. 312.60. Washington, DC: U.S. Government Printing Office; 1997.
9. Title 21 Code of Federal Regulations. 312.68. Washington, DC: U.S. Government Printing Office; 1997.
10. Investigations Operations Manual. Chapter 5 - Establishment Inspection. http://.fda.gov/ora/inspect_ ref/iom/96ch5.html, June 1, 1998.
11. Spilker B. Guide to Clinical Trials. New York, NY: Raven Press; 1991;450-452.
12. Recordkeeping in clinical investigations. http://www. fda.gov/oc/oha/record.html, June 1, 1998.
13. Good Clinical Practices in Investigational Product Research Meeting: Notice of meeting. Federal Register. 1998;63:30001.