Laws & guidances
GCP
www.ich.org/cache/compo/276-254-1.html
Good Clinical Practice guidance
21 CFR part 11
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11&showFR=1
American law applicable to Computerized Systems
Computerized Systems Used in Clinical Investigations
www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.PDF
American guidance to interpret 21 CFR part 11 for clinical research
GCP training
www.gcpcursus.nl
Cursussen Good Clinical Practice (GCP) en
Medisch Wetenschappelijk Onderzoek met Mensen (WMO).
Basis van de Regelgeving en Organisatie van Klinisch Onderzoek
Technical standardization
CDISC
www.cdisc.org
Clinical Data Interchange Standards Consortium. The mission
of CDISC is to develop and support global, platform-independent data
standards that enable information system interoperability to improve
medical research and related areas of healthcare.
eClinical Forum
www.eclinicalforum.com
The eClinical Forum was formed in 2000 by Pharmaceutical
Industry representatives. It serves those members of the industry, vendors
and service suppliers who are (or will be) involved in handling of electronic
clinical research data.
GCdmP
www.scdm.org
Good Clinical data management Practices Guide.
Tools
Getting Things Done
www.meereffect.nl (Dutch)
Een gestroomlijnde manier om zo effectief mogelijk te
werken.
Associations
ACRP
www.acrpnet.org
Association of Clinical Research Professionals
Association for Clinical Data Management
www.acdm.org.uk
The Association for Clinical Data Management has a large,
diverse membership and aims to lead the development and appreciation
of the essential activities of the Clinical Data Management profession.
Drug Information Association
www.diahome.org
The DIA strives to maintain its position as the premier
organization within the health care arena for the exchange and dissemination
of information by continuing to provide a neutral forum, respecting
and welcoming all participants, and offering quality-driven programming.
Dutch Association of Research Quality Assurance
www.darqa.org (Dutch)
DARQA heeft ten doel een platform te bieden voor verdere
ontwikkeling van kwaliteitszorg in onderzoeks– en ontwikkelingsorganisaties
en de implementatie daarvan te bevorderen.
Pharmaceutische Statistiek en Data Management
www.psdm.nl (Dutch)
Deze werkgroep richt zich op statistiek en data management
in onderzoek van de farmaceutische industrie.
Society for Clinical Data Management
www.scdm.org
The Society for Clinical Data Management (SCDM) is a
non-profit professional society founded to advance the discipline of
Clinical Data Management. The binding interest of all members is quality
clinical data management practices as resulted in the Good Clinical
Data Management Practices Guide.
Zeist