Certification for Data Managers- How high is the bar?

Transcription

1 Certification for Data Managers- How high is the bar? Linda M. Talley, CCDM International Network of Clinical Data Management Associations-(INCDMA) Chair Society for Clinical Data Management (SCDM)- Chair 21-October Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 1

2 Agenda Data Management Evolution Staffing and training needs Options available to address training and certification Conclusions 3 3 Data Management evolution In the beginning, there was Paper Data Management viewed as a data processing role Activities included data entry, data validation, query resolution, coding Lots of time and energy spent just tracking pieces of paper! 4 4 2

3 Paper: Staffing and training needs Training needs were related to paper data entry and computer fit corrections for the data, query writing, data validation activities Staff experience and background more administrative/clerical in nature Some needs for key positions to have scientific background (ie. Coding, AE/Con med evaluation) 5 5 Data Management evolution Introduction of EDC, EHR, EPRO, outsourcing Data Manager role requires more in depth technical knowledge Need expertise in CDISC, Data Standards, IT system validation, Regulatory requirements Outsourcing partnerships require relationship management skills 6 6 3

4 Staffing and training needs New technology and work models challenge traditional training for DM New training required for electronic data capture (21CFR part 11, System validation, EHR, etc.) Staff experience and background required to have strong technical and scientific background 7 7 A Tale of 2 roles. Company sourcing models result in Data Management role evolving Deep technical role Project management/oversight role Challenge for many Data Managers to assume an oversight role 8 8 4

5 How do you measure and prove your Data Management staff are trained and qualified to perform the roles and responsibilities in this new environment? 9 9 Training and Certification approaches Companies have needed to enhance their training programmes for Data Managers External training courses available from outside organizations (ie. CDISC, DIA, ACDM, SCDM, etc) War for talent- how can you evaluate current and incoming staff to ensure foundational level of knowledge and expertise?

6 College Week- ACDM Week long training programme Training in modular format Tailored to all levels of experience Classroom, online e-learning, webinars Available to be run onsite for company staff Data Manager Certification-SCDM SCDM University- online courses, webinars, Good Clinical Data Management Practices (GCDMP) document Training supports certification programme- Certified Clinical Data Manager (CCDM) Passing the exam establishes credibility criteria and standards of knowledge across all aspects of the evolving DM role

7 Fellowship of the CCDM (Certification Committee) Define CCDM Develop Code of Ethics Establish Application Process Identify Contractor (Prometric) Design Certification Process The Two Exams (Beta & Final) Develop Exam Questions Release Beta Test Reach Required Number of Testers! Review Results and Comments Determine Cut Score Certify Candidates!!!! Release Final Exam File Certification Mark Application Return of Certification (Lifetime Maintenance) Review Exam Item Performance Statistics Assess Trends In Industry Develop and Beta Test New Items Launch Certified Senior CDM Program Market Certification Program SCDM Certification Highlights 2008 Total of 347 CCDMs 2009 Total of 467 CCDMs (YTD) Domestic (US) = 369 International = 98 Top 3 International India = 39 Canada = 23 South Africa =

8 Conclusions- The bar is higher The role of the Data Manager is evolving Training, education, and staffing required to perform the role are higher than ever before Training programmes and certifications are available externally to help close the gap Thank You!! Questions or comments: Contact info