NOTE:
While other GxP are proposed by the regulatory agencies, there is no officially issued guidance on GSP (Good Statistical Practices) and GCDMP (Good Clinical Data Management Practices).
However, the principles of these two good practices have been largely covered in ICH guidances, specifically, E9 (Statistical Principles for Clinical Trials) and E6 (Good Clinical Practice).
- CPMP/ICH/363/96. ICH E9 Statistical Principles for Clinical Trials. link
- CPMP/ICH/135/95. E6 (R1) Guideline for good clinical practice. link
Research ethics, publication ethics and good practice guidelines from EQUATOR
International
ICH
ICH Topic E 6 (R1): Guideline for Good Clinical Practice. CPMP/ICH/135/95, EMEA London, 1996/2002
ISO
ISO 27001-2005 – Information technology — Security techniques — Information security management systems — Requirements
ISO Revision 2013: ISO/IEC 27001: 2013 Information technology — Security techniques — Information security management systems — Requirements
FDA
Guidance for Industry: Computerized Systems Used in Clinical Trials and 21 CFR Part 11 (pdf). Tutorial
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
EU
SANCO/C8/AM/sl/ares(2010)1064599. EudraLex. The Rules Governing Medicinal Products in the European Union. Volume 4 Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex 11: Computerised Systems link
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 link
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal of the European Communities, L121/34-121/44 link
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Official Journal of the European Communities L 91/13-91/19 link
EMA
EMA GCP Inspections procedure home page
EMA/INS/GCP/454280/2010. GCP Inspectors Working Group (GCP IWG). Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials link
EMEA/INS/GCP/444656/2007 Corr*. GCP Inspectors Working Group. Procedure no: INS/GCP/3/III-Rev 1. ANNEX III TO Procedure for Conducting GCP Inspections Requested by the EMEA: Computer Systems. link
Guidance on Good Practices for Computerised Systems in Regulated “GXP” Environments. The EU GCP inspectors agreed to use as the reference for inspection of Computer Systems the published. PIC/S Guidance on Good Practices for Computerised Systems in Regulated “GXP”. This supersedes: version dated 20 September 2007 (updated in this Rev 1 version the reference to the PIC/S Guidance)
Society for Clinical Data Management
Good Clinical Data Management Practices. Society for Clinical Data Management. Contact GCDMP at http://www.scdm.org
The European Clinical Research Infrastructures Network (ECRIN) is a sustainable, not-for-profit infrastructure supporting multinational clinical research projects in Europe.
Standard requirements for GCP compliant data management in multinational clinical trials link
Wolfgang Kuchinke, Christian Ohmann, Qin Yang, Nader Salas, Jens Lauritsen, Francois Gueyffier, Alan Leizorovicz, Carmen Schade-Brittinger, Michael Wittenberg, Zoltan Voko, Siobhan Gaynor, Margaret Cooney, Peter Doran, Aldo Maggioni, Andrea Lorimer, Ferran Torres, Gladys McPherson, Jim Charvill, Mats Hellstrom, Stephane Lejeune. Heterogeneity prevails: the state of clinical trial data management in Europe – results of a survey of ECRIN centres. Trials 2010, 11:79 (21 July 2010): The article discusses the use of different Clinical Data Management Systems (CDMS) in Europe. http://www.trialsjournal.com/content/11/1/104 Supplementary Info
Christian Ohmann, Wolfagang Kuchinke, Steve Canham, Jens Lauritsen, Nader, Salas, Carmen Schade-Brittinger, Michael Wittenberg, Gladys McPherson, John McCourt, François Gueyffier, Andrea Lorimer, Ferran Torres, Ecrin Working Group on Data Centres. Standard requirements for GCP-compliant data management in multinational clinical trials. Trials 2011, 12:85 (March 2011). link
Other
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. link
Clinical Data Interchange Standards Consortium (CDISC) Operational Cata Model [http://www.cdisc.org/odm]