1. Society for Clinical Data Management Draft Definition of Clinical Research Data Management (CRDM) Meredith Nahm, PhD Duke Center for Health Informatics Thursday, March 21, 2013 AMIA CRI Working Group Meeting

2. Society for Clinical Data Management (SCDM) non-profit professional association Started in 1994 Mission: to support Clinical Data Management professionals Vision: to be the world’s leading advocate for the discipline of clinical data management. Membership 2400, 80% US, 20% international Annual meeting attendance: 400-600

3. CRI & CDM Site Selection Start-up IRB approval Patient Recruit -ment Data collection & processing Analysis & reporting FDA review Post market Surveil -lance Study design Clinical Research Informatics Clinical Trial Data Management Translation Into practice Rest of clinical research Site Selection Start-up IRB approval Patient Recruit -ment Data collection & processing Analysis & reporting review Study design Clinical Trials

4. SCDM Profession Milestones SCDM founded 1994 GCDMP vs 1.0 2000 SCDM Code of Ethics 2003 Certification exam vs 1 Beta test 2004 1 st SCDM fall conference, Philadelphia 1997 First SCDM Webinar 2005 First SCDM Certification exam training, Colorado 2003 First SCDM On- line course 2009

5. From US to International Member of INCDMA First international conference: Toronto 2004 Transferred mgt. contract to international association mgt. company 2011 Second international conference: Mumbai 2013

6. What does SCDM do ? monthly e-newsletter, Data Connections quarterly digital peer-reviewed journal (not indexed), Data Basics Good Clinical Data Management Practices (GCDMP) maintained since version 1.0 in 2000 –English and Japanese –Referenced in FDA draft guidance Certification (CCDM): 596 current CCDMs Professional development courses

7. Discipline Maturity Model Learn by trial & error OR skill training Learn by apprenticeship, OJT, Best Practice Learn by formal degree programs, OJT 2 o Work activity is an “art” Quality depends mainly on individual skill Activities coalesce, form practice supported by body of knowledge Quality depends mainly on individual skill Profession supported by a scientific discipline Quality depends on capable processes No standardization Pseudo- standardization through best practice Standardization Low High Skilled tradeProfessionDiscipline

8. We Are What We Know And, what we know grows and evolves year after year as basic and applied informatics research generates new knowledge. Fall meeting Sept 22-25, presented a draft definition of the profession for comment.

9. Updated Draft Definition Purpose of the definition: explicit articulation of the goals, value and products of the profession Three new things: 1)recognition of Informatics as underlying science 2)narrowing of the name to research, i.e., CRDM rather than CDM 3)in response to broadening roles in industry acknowledgement of and intention to support professionals across the full spectrum of the NIH definition of clinical research … not just RCTs

10. Comments Vetted at Fall 2012 SCDM annual meeting Received 42 comments 19 Persuasive 17 Not persuasive 5 Supportive

11. Current Definition Clinical Research Data Management is the expert application of informatics theories and methods to the definition, collection and processing of data for clinical studies and the design of associated work and data flow. Clinical Research Data Management assures the collection, integration and availability of data at appropriate quality and cost. Clinical Research Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research, and ultimately public health and confidence in therapeutics and therapeutic interventions.

12. Next Steps Sharing in the AMIA CRI-wg Sharing again with SCDM membership Send comments to: meredith.nahm@duke.edu