October 2004
Introducing... INCDMA
The International Network of Clinical Data Management Associations
Clinical Data Management is practised wherever pharmaceutical research and development is conducted. And Clinical Data Managers the world over are faced with essentially similar issues and challenges. Just as several other disciplines involved in pharmaceutical R&D have found it beneficial to collaborate across national boundaries, there is now a formal international forum for Clinical Data Managers, the INCDMA.
The initial "seed" for the INCDMA was "planted" by the UK-based Association for Clinical Data Management (ACDM) in 1994 when they formed an International Collaboration Sub-Committee with the remit to network with other existing CDM associations worldwide and to help overseas groups who had shown interest in ACDM establish their own Special Interest Group, thus extending the CDM discipline.
The first contacts were made with colleagues in the US, Nordic Countries, Germany, Belgium and France. This resulted in an International Collaboration session at the ACDM annual conference in which ACDM attendees heard about CDM issues in Japan (cultural differences and software differences) and France (use of many local laboratories by patients). The German association DVMD, was found to be the oldest association and had already set up university courses that covered data management (within a Medical Documentation course) as a discipline.
From these early contacts, ACDM trainers were invited to the Inaugural Nordic DM association meeting in 1995 together with a representative from EORTC (European Organization for Research and Treatment of Cancer) data centre.
The US group spawned from the PhRMA association considered joining in to the ACDM, however the legal and administrative logistics proved too difficult and so the SCDM was born and they requested that they might use a similar logo, to show the close-working relationship to the ACDM.
The International Collaboration Sub-Committee Chairman was invited to the inaugural meeting of the SCDM and provided an overview of the UK activities including a description of the special interest groups, training courses and ongoing initiatives.
The ICC Sub-Committee gained new energy with a new Chairman in 2000 and contacts were strengthened and extended as far afield as Australia. A more formal network of e-mail contacts and quarterly teleconferences was initiated. In the teleconferences, "hot" topics (e.g. EDC, MedDRA, CDM Competencies and Career Opportunities) were discussed and information on the activities organised by the member associations was shared.
During 2002, the network participants expressed a growing desire for the organisation to become more recognised. While wishing to continue the information exchange and discussions of relevance to the member associations, it was felt important to establish the identity of a truly international body, recognised by the "outside world" as capable of being used as an important conduit through which information could be transferred.
This new international body would provide a forum for presenting data that may impact clinical data management worldwide and they could collate feedback from literally thousands of Clinical Data Managers through their national member associations. ...And so the International Network of Clinical Data Management Associations, INCDMA, was born.
INCDMA Member Associations
Australia – Australian Regulatory and Clinical Scientists – ARCS
Australia is represented in the INCDMA by the professional association for Australian Regulatory and Clinical Scientists (ARCS). ARCS has approximately 1800 members who are involved in regulatory affairs, clinical research, health economics, medical devices, diagnostics, and the provision of medical information in the Australian and New Zealand Pharmaceutical and Health Care Industries. ARCS is a "not for profit" association which is governed by an elected Council. The members are accepted into one of five membership categories: Full, Associate, Student, Retired and Life status may also be awarded.
The ARCS Secratariat address is:
Suite 303, 13 Spring Street,
Chatswood, NSW 2067
Tel. +61 2 9904 7566
Fax +61 2 9904 7599
www.arcs.org.au.
Andrew Taylor, through the Data Management and Biostatistics Education Sub-Committee, is the INCDMA contact (tel. +61 2 9454 9159
ARCS currently has 11 Education Sub-Committees (ESC), one of which focuses on Data Management and Biostatistics. The role of the ESC is to provide educational opportunities for ARCS members who are data managers and biostatisticians, primarily in the form of evening seminars and sessions at the ARCS Annual Scientific Congress (June) and Annual General Meeting (November). These meetings also allow networking opportunities for those with a shared interest in these disciplines. The ESC, in conjunction with the ARCS Education Manager is also currently investigating possibilities for running an introductory data management course in Australia.
France – Data Management Biomedical – DMB
INCDMA's French member association and one of the Network's prime initiators, Data Management Biomedical (DMB), is an independent, non-profit, professional society to advance the discipline of Clinical Data Management. DMB has around 250 members, 98% of whom are based in France.
The DMB administrative contact address is: DMB/IFIS, Université de Marne la Vallée,
5 Boulevard Descartes, Champs sur Marne, 77454 Marne la Vallée, Cedex 2 France.
The Association's contacts are Francis Golly and Carine Javierre (Laboratoires Fournier); and its website is www.dmb-asso.com. Joris Cauquil is the current DMB Chair, and its INCDMA contact (tel : +33 5 63 61 30 35).
The DMB's vision is to promote data management activities, notably by: bringing interested parties together, and making it easier for them to exchange information; making the profession known through publications, presentations, conferences, training, etc.; optimising working methods and anticipating evolution; having a special relationship with the authorities, software providers, CROs, etc.; and establishing relationships with other data managers' associations in Europe and globally.
Eleven working groups producing documents or organising meetings are currently active within DMB: biological data, quality, coding, new technologies, training, reactivity task force, international network, national network, communication / web, CDISC, and points to consider.
DMB offers one to three meetings each year: the Annual Meeting in May/June, and "topics" meetings (coding in 1999 and 2002, blind review in 2000, new technologies in 2000, missing data in 2002, CDISC in 2003, etc.).
Liaison Info DMB, the DMB newsletter, is published quarterly, and includes articles from members, conference proceedings, and happenings throughout the organization (working group activities, books review, points to consider, etc.).
Germany – Association of Medical Documentalists – DVMD
From Germany, the INCDMA member is the German Association of Medical Documentalists (DVMD), which is an independent, non-profit, professional association in the area of medical documentation and has approximately 1100 members. DVMD members work in the Pharmaceutical Industry and Contract Research Organizations, as well as in hospitals, laboratories and other institutes or software companies dealing with health data. Clinical Data Managers are a sub-group of the members of the DVMD.
The DVMD's administrative contact address is:
PO Box 10 01 29, D-68001 Mannheim, Germany
Tel/Fax +49 6205/1026 04
Email dvmd@dvmd.de
www.dvmd.de
Markus Stein is the current DVMD chair, and Margarete Rudloff
(Kendle, tel. +49 89 99 39 13-122) its INCDMA contact.
The main goals of DVMD are to support the recognition of Medical Documentalists in the Health Care system in Germany by public relations initiatives and providing information material. Further important objectives are the harmonization of education for Medical Documentalists and the provision of training opportunities. The DVMD co-operates with related organizations in the health arena nationally as well as internationally.
Several working groups support the Board of the association. These groups deal with harmonisation of education, developing and conducting training courses, public relations, developing information brochures and a newsletter, co-operation with other associations and organising of conferences.
For education in the area of medical documentation, the main opportunities available in Germany are graduate courses for 'Documentation in Life Science' or 'Medical Documentation and Informatics' (4 years education) and vocational schools for certification as 'Medical Documentalist' (3 years) 'Medical Documentation Assistant' (2 years). The DVMD offers a variety of training courses in the areas of Health Care and Clinical Research.
The products available to all members are the quarterly newsletter, brochures regarding education and training, mailings, membership directory and access to the website of the DVMD. The DVMD conducts annual conferences for information exchange.
North America – Society for Clinical Data Management – SCDM
INCDMA's North American member association is the Society for Clinical Data Management, Inc. (SCDM), an independent, non-profit, professional society to advance the discipline of Clinical Data Management. The SCDM has around 1600 members, 98% of whom are based in North America.
The SCDM's administrative contact address is:
611 East Wells Street, Milwaukee, WI 53202
Tel. +1 414-226-0362
Fax +1 414-276-3349
www.scdm.org
Sally Cassells (Lincoln Technologies) is the current SCDM Chair, and Alec Vardy
(CV Therapeutics, tel. +1 650 384 8519) its INCDMA contact.
The SCDM's vision is to be the professional organization of choice for Clinical Data Management in North America, and its mission is promoting Clinical Data Management excellence. Six sub-committees are currently active within the SCDM. The Effective Use of Technology Committee monitors technical trends and identifies technology options of relevance to CDM; the Good Clinical Data Management Practices (GCDMP) Committee is responsible for developing and publishing the Society's GCDMP document. The Society also operates Membership, Publications, Professional CDM Certification and Worldwide Web Site committees.
The SCDM offers two meetings each year: the Spring Forum, an educational seminar offering a unique discussion format for Data Managers at a management level, and the Fall Conference, a professional development conference aimed at its general membership. DataBasics, the SCDM's newsletter, is published quarterly, and includes articles from members, conference proceedings, and happenings throughout the organization. The society also publishes a monthly e-newsletter.
Caroline Fenning, Roche
Eva Hammarstrom-Wickens, Orion Pharmaceuticals