Efficient source data verification

Indian Journal of Pharmacology

Volumn 32, Issue 3, 2000, Pages 180-186

  Khosla, R ^a   Verma, D D ^b   Kapur, A ^c   Khosla, S ^d  

^a Piramal Enterprises Limited   (India)

^b PHILIPPS UNIVERSITY MARBURG   (Germany)

^c RANBAXY RESEARCH LABORATORIES   (India)

^d UNIVERSITY OF LUCKNOW   (India)

Author keywords

Good clinical practice; Source data verification

Indexed keywords

CLINICAL PRACTICE; CONFIDENTIALITY; CUSTODY; DOCUMENTATION; DRUG INFORMATION; INFORMATION PROCESSING; MONITORING; PRACTICE GUIDELINE; REVIEW; STAFF TRAINING;

EID: 0033918218     PISSN: 02537613     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (7)

1. Khosla R. GCP guidelines: differences between the ICH and WHO guidelines. Good Clin Pract J 1998;3:24-30.
2. Verma D.D., Sharma G., Arora H. ; GCP guidelines : FDA Vs WHO. Good Clin Pract J 1999;6:18-22.
3. ICH Harmonized Tripartite Guidelines for Good Clinical Practice [E6: good clinical practice:consolidated guideline], 1997.
4. WHO guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, 1994.
5. Code of Federal Regulations (CFR) Good Clinical Practice Guidelines Parts 50, 54, 56, 312 & 314, April 1999.
6. Bruckheimer M. FDA's Inspections of Clinical Investigators. Drug Inf J 1993;27:213-6.
7. US Department of Health and Human Services, US Food and Drug Administration, 21 CFR Part 11, Electronic Records; Electronic Signatures: Final Rule, 1997.