Standard requirements for GCP-compliant data management in multinational clinical trials

Trials

Volumn 12, Issue , 2011, Pages

  Ohmann, Christian ^a   Kuchinke, Wolfgang ^a   Canham, Steve ^b   Lauritsen, Jens ^c   Salas, Nader ^d   Schade Brittinger, Carmen ^e   Wittenberg, Michael ^e   McPherson, Gladys ^f   McCourt, John ^g   Gueyffier, Francois ^h   Lorimer, Andrea ⁱ   Torres, Ferràn ^j  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^c UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^d Rigshospitalet   (Denmark)

^e PHILIPPS UNIVERSITY MARBURG   (Germany)

^f UNIVERSITY OF ABERDEEN   (United Kingdom)

^g Dublin Centre for Clinical Research   (Ireland)

^h LOUIS PRADEL HOSPITAL   (France)

ⁱ ANMCO RESEARCH CENTER   (Italy)

^j HOSPITAL CLÍNIC   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CERTIFICATION; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); COMPUTER PROGRAM; COMPUTER SYSTEM; INFORMATION PROCESSING; PRACTICE GUIDELINE; STANDARDIZATION; TOTAL QUALITY MANAGEMENT; HUMAN; INFORMATION RETRIEVAL; INFORMATION SYSTEM; INTERNATIONAL COOPERATION; METHODOLOGY; MULTICENTER STUDY (TOPIC); QUALITY CONTROL; STANDARD;

CERTIFICATION; CLINICAL TRIALS AS TOPIC; DATA COLLECTION; GUIDELINE ADHERENCE; HUMANS; INFORMATION MANAGEMENT; INFORMATION STORAGE AND RETRIEVAL; INTERNATIONAL COOPERATION; MULTICENTER STUDIES AS TOPIC; QUALITY CONTROL; RESEARCH DESIGN;

EID: 79953067734     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-85     Document Type: Article

References (26)

1. Kuchinke W, Ohmann C. A technical introduction to the basic requirements of clinical trials. EJHPP 2009/5 15:20-22.
2. Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J, et al. Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres. Trials 2010, 11(1):79-89. 10.1186/1745-6215-11-79, 2918594, 20663165.
3. ICH Topic E 6 (R1) Guideline for Good Clinical Practice. CPMP/ICH/135/95, EMEA London, 1996/2002 ICH Topic E 6 (R1).
4. Directive 2001/20/EC. Official Journal of the European Communities, L121/34-121/44
5. Directive 2005/28/EC. Official Journal of the European Communities L 91/13-91/19
6. Annex 11 - Computerized Systems. EudraLex - Volume 4: Guidelines for good manufacturing practices for medicinal products for human and veterinary use. Bruxelles 31 October 2008
7. FDA Guidance for Industry: Computerized Systems Used in Clinical Trials. 1999, FDA.
8. FDA 21 CFR Part 11, Electronic Records; Electronic Signatures. Final Rule, Federal Register 1997, 62(54):13429. FDA., http://www.labcompliance.com/tutorial/part11/default.aspx
9. Lauritsen JM. Implementation of Good Clinical Practice Software. Draft, University of Southern Denmark, Denmark 2007,
10. KKS Network Policy Document. University of Cologne, Germany (2001, updated 2007) KKS Network.
11. BSI Grundschutzhandbuch des Bundesamtes für Sicherheit in der Informationstechnik (BSI). Bonn 1998, updated 2001, BSI.
12. DIMS Project Team Trials Units Information Systems - System Standards. Data and Information Management Systems Project. UKCRC/NIHR 2009, DIMS Project Team.
13. Pharmaceutical Inspection Convention PIC/S Guidance: Good Practices for Computerised Systems in regulated "GXP" environment. PIC/S, September 2007, Geneva Switzerland Pharmaceutical Inspection Convention.
14. GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems. International Society for Pharmaceutical Engineering, February 2008, Tampa, Fl., USA
15. ISO 27001-2005 - Information technology -- Security techniques -- Information security management systems -- Requirements.
16. Good Clinical Data Management Practice. Version 4, Society for Clinical Data Management 2005,
17. Demotes-Mainard J, Ohmann C. European Clinical Research Infrastructures Network: promoting harmonisation and quality in European clinical research. Lancet 2005, 365, 9454:107-108.
18. Directive 95/46/EC. Protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal of the European Communities, L 281/31-281/39
19. GCP Inspectors Working Group EMEA Reflection paper on expectations for electronic source documents used in clinical (draft). EMA, London 2007, (meanwhile the final document has been published: GCP Inspectors Working Group: Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials. EMA, London, 1 August 2010), GCP Inspectors Working Group.
20. ECRIN TWG Deliverable D10: GCP-compliant data management in multinational trials. Work package 4 2008, not public, ECRIN TWG., http://www.ecrin.org/index.php?id=274
21. Mullendore B. Computer Validation Master Planning - Technical Guide. IVT 2002,
22. Ohmann C, Kuchinke W. Future developments of medical informatics from the viewpoint of networked clinical research. Interoperability and integration. Methods Inf Med 2009, 48(1):45-54.
23. Clinical Data Interchange Standards Consortium (CDISC) Operational Cata Model. (Last acceessed: 17 March 2011)., http://www.cdisc.org/odm
24. Blamey RW, Cataliotti L. EUSOMA accreditation of breast units. European Journal of Cancer 2006, 42:1331-1337. 10.1016/j.ejca.2006.04.003, 16766180.
25. Medicines and Healthcare Products Regualtory Agency (MHRA). (Last accessed: 17 March 2011)., http://www.mhra.gov.uk/
26. Joint Accreditation Committee - ISCT (Europe) & EBMT. (Last accessed: 17 March 2011)., http://www.jacie.org/