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Society for Clinical Data Management Draft Definition of Clinical Research Data
Management (CRDM)
Meredith Nahm, PhDDuke Center for Health Informatics
Thursday, March 21, 2013AMIA CRI Working Group Meeting
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
CRI & CDM
SiteSelectionStart-up
IRB approval
PatientRecruit-ment
Data collection
& processing
Analysis&
reporting
FDAreview
Post marketSurveil-lance
Studydesign
Clinical Research Informatics
Clinical Trial Data Management
TranslationInto
practice
Rest of clinical research
SiteSelectionStart-up
IRB approval
PatientRecruit-ment
Data collection
& processing
Analysis&
reporting review
Studydesign
Clinical Trials
SCDM Profession Milestones
SCDM founded
1994
GCDMP vs 1.0
2000
SCDM Code of Ethics
2003
Certification exam vs 1 Beta test
2004
1st SCDM fall conference, Philadelphia
1997
First SCDM Webinar
2005
First SCDM Certification exam training, Colorado
2003
First SCDM On-line course
2009
From US to International
Member of INCDMAFirst international conference: Toronto 2004Transferred mgt. contract to international association mgt. company 2011Second international conference: Mumbai 2013
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(GCDMP) maintained since version 1.0 in 2000– English and Japanese– Referenced in FDA draft guidance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
Discipline Maturity Model
Learn by trial & error OR skill training
Learn by apprenticeship, OJT,
Best Practice
Learn by formal degree
programs, OJT 2o
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 trade Profession Discipline
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.
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
Comments• Vetted at Fall 2012 SCDM annual meeting • Received 42 comments
19 Persuasive 17 Not persuasive 5 Supportive
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.
Next Steps
• Sharing in the AMIA CRI-wg• Sharing again with SCDM membership
Send comments to: [email protected]
