Good Clinical Practice and audits for dual X-ray absorptiometry and X-ray imaging laboratories and quality assurance centers involved in clinical drug trials, private practice, and research

Journal of Clinical Densitometry

Volumn 1, Issue 4, 1998, Pages 323-337

  Blunt, Barbara A ^a,d   Jones, DeJane ^b   Svensen, Russell K ^a   Hans, Didier B ^a,c   Feinblatt, Joel D ^b   Genant, Harry K ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b 206 Carnegie Center   (United States)

^c Ctr Lyonnais Invest Osteoporoses   (France)

^d Osteoporosis and Arthr Res Group   (United States)

Author keywords

Clincal trials; Dual X ray absorptiometry (DXA); Good Clinical Practice(GCP); Osteoporosis; Quality assurance; Regulatory audit; Vertebral fracture

Indexed keywords

EID: 0012419723     PISSN: 10946950     EISSN: None     Source Type: Journal    
DOI: 10.1385/JCD:1:4:323     Document Type: Article

References (20)

1. Gowin W, Felsenberg D. 1998 Acronyms in osteodensitometry. J Clin Densitometry 1 (2): 137-139.
2. Goodson RL. 1995 Good clinical practices: past, present, and future. Quality Assurance 4(1):60-67.
3. Friederichs E, Spitzer SG, Bach R. 1994 Efficacy and quality in clinical trials. Requirements to the investigator site. European Economic Community. Arzneimittel-Forschung 44(2): 182-184.
4. Idanpaan-Heikkila JE. 1994 WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Medi 26(2):89-94.
5. 21 Code of Federal Regulations (CFR) 50, 56, 312, 314, 812, 814.
6. International Conference on Harmonization/ European Federation of Pharmaceutical Industries' Associations. 1996 ICH E6 "Good Clinical Practice: Consolidated Guideline." ICH Secretariat c/o IFPMA, Geneva, Switzerland.
7. 21 CFR 312.120 (full text of Declaration of Helsinki).
8. Heilman RD. 1995 Drug development history, "overview," and what are GCPs? Quality Assurance 4(1):75-79.
9. Meinert CL. 1996 Clinical Trials Dictionary. Johns Hopkins Center for Clinical Trials, Baltimore.
10. 21 CFR 812.140.
11. Horowitz AM. 1995 FDA audit of non-clinical studies. Quality Assurance 4(3): 227-238.
12. Isaman V, Thelin R. 1995 Standard operating procedures (SOPs): reason for, types of, adequacy, approval, and deviations from and revisions to. Quality Assurance 4(3): 167-171.
13. Gassman JJ, Owen WW, Kuntz TE, Martin JP, Amoroso WP. 1995 Data quality assurance, monitoring, and reporting. Controlled Clin Trials 16:104S-136S.
14. IEEE Std 1012-1986 (Reaff 1992) IEEE Standard for software verification and validation plans (ANSI). Institute of Electrical and Electronics Engineers, Inc., New York.
15. Davey J. 1994 Tools and techniques for the development of secure software. Int J Bio-Med Computing 35 Suppl: 173-178.
16. Platt KJ. 1995 Evolution of a companywide validation program. Quality Assurance 4(4):336-339.
17. Twitty MM, Martin SA, Henry JL, Nowicki LJ, Dabrowski MJ, Veresh LM. 1997 A procedure for assessing a contract testing facility: one sponsor's perspective. Quality Assurance 5(1):61-68.
18. Spilker B. 1991 Guide to Clinical Trials. Raven, New York.
19. Lepore P. 1995 The 10 essential activities of the quality assurance unit. Quality Assurance 4(1):29-33.
20. Ransom C, Zamora G, Jones L. 1995 The development and implementation of a quality assurance master audit plan. Quality Assurance 4(1):80-82.