SCDM Professional CDM Certification Committee

Committee Roster

Leigh R. Smith, CCDM Co-Chair Associate Director Clinical Data Management Shire Jennifer Duggan, CCDM Co-Chair Manager, Clinical Data Management Cetero Research Vesna Zovkic, CCDM Board Liaison Clinical Research Manager DePuy Orthopaedics, a Johnson & Johnson Company Mir Imran Ali, CCDM Manager, Data Operations Quintiles Technologies Private Ltd. Hugh Capper Head of Data Management The George Institute for International Health Karen Dhami, CCDM Clinical Data Manager Amgen Wanda S. Doles, CCDM Manager, Clinical Data Management, Clinical Pharmacology Quintiles Dorothy B. Dorotheo, CCDM Director, Clinical Data Management Intermune John Estrada, CCDM Product Development Manager Nextrials, Inc. Kathy Haag, CCDM Associate Clinical Data Management Consultant Eli Lilly and Company

Michelle Shuman Hamilton Sr. Manager, Clinical Data Management Boston Scientific Corporation Judy Hodgson Director, Clinical Data Management Kendle International Inc. Susan Krikorian, CCDM Senior Manager, Data Management CV Therapeutics Shannon Labout, CCDM Senior Consultant CSS Informatics, a division of PPD Mark Laskowski, CCDM Clinical Data Manager Sanofi Pasteur, Inc. Angel Lazarov, CCDM CDM Project Manager/Leader i3 Statprobe Nimita Limaye, CCDM VP - CDM and Medical Writing SIRO Clinpharm Pvt. Ltd Diane Rapp Professional Development Trainer Merck & Co. Whitney Smith, CCDM Manager Clinical Data Management Westat Andrea Visoski Clinical Data Coordinator III MedImmune, Inc.

SCDM Professional CDM Certification Committee Charter
(Version 6.2)

I. INTRODUCTION

II. MISSION/PURPOSE

• To ensure the certificant's experience with the SCDM certification program is responsive and professional
• To ensure that standard criteria and requirements for professional CDM certification reflect industry needs
• To guard against obsolescence in knowledge of Clinical Data Managers skills and competencies by defining requirements for recertification (i.e. maintenance of certification status)
• To develop the quality standards for education and training programs that will be recognized by SCDM for supporting the acquisition and maintenance of professional certification status for Clinical Data Managers
• To educate our membership and their customers on the value of certification and engage their support

III. ORGANIZING TO ACHIEVE OUR MISSION

Following is a description of each role and subcommittee as well as their respective major deliverables:

• Chair/co-chair(s) - Provide leadership and oversight for the overall committee. Ensure overall objectives are being achieved. Coordinate efforts and manage inter-dependencies across subcommittees. Recruit and orient new committee members. Ensures a succession plan is in place. This is a BOT appointed position.
• BOT Liaison - Assumes duties of the Chair/co-chair(s) in his/her absence. Works with the Chair /co-chair(s) to ensure that the committee is adequately resourced and the committee's activities are in accordance with the approved committee charter. The BOT Liaison assures board members are duly informed of committee activities and issues. BOT Liaison also ensures that decisions outside the scope, remit or budget of the committee are forwarded to the BOT for action. The BOT Liaison is a BOT appointed position.
• Program Administration and "Customer-Care" - The Program Administration and Customer Care subcommittee will oversee the day-to-day operations of the certification program. This subcommittee will also serve, in conjunction with the Marketing subcommittee, as the "Public Relations" arm of the certification committee.
• Lifetime Maintenance - This subcommittee is primarily charged with ensuring that the standard criteria and requirements for professional CDM certification and recertification remain current, valid and relevant. A certification exam project manager may lead this subcommittee.
• Education and Training - The Education and Training subcommittee will design and execute a strategy for providing certificants with the resources or training materials needed to help them achieve and maintain professional certification. Out of scope: general CDM training.

IV. TERMS OF ENGAGEMENT

• Regular (Monthly) 1 hour telecons with Subcommittee Chairs, Liaisons or at least one member of the subcommittee
• Subcommittees may determine their own meeting schedules, agendas and will publish their own minutes
• Subcommittees will develop their own operating plans to achieve deliverables and provide monthly progress reports
• Committee and subcommittee chair positions are assigned by the BOT.
• Committee and subcommittee members are volunteer positions and confirmed by committee and subcommittee chairs.
• All committee and subcommittee members must be members of SCDM in good standing.
• Agendas will be set prior to each meeting
• Start and end all meetings on time
• Quorum = Chair and ½ Committee present
• People who can't attend will notify chair in advance so a decision can be made as to whether or not to hold the meeting
• Committee membership is contingent on continued active participation & delivery against commitments; e.g.. Three absences in a row results in removal from the committee
• Meeting minutes will issue within 5 business days of meeting. Minutes will contain:
1. Items discussed and agreements/decisions reached. Decisions reached will include alternatives considered and decision criteria.
2. Action items
• Action items will be clearly defined with:
1. Deliverables
2. Responsible party(ies)
3. Due date
• Attendees complete review of minutes within 2 business days of receipt
• Consensus will be used as the primary vehicle for making decisions (e.g. acceptance of deliverables, project plans)
• Decisions by the committee that impact budget, SCDM policy or the mission of this committee will be framed as recommendations to the BOT where the final decision will be made.
• No comment implies agreement
• Comments should add value. If you disagree, offer an alternative.
• Minutes will be issued to Committee members and Board liaison
• Feedback to/from Board of Trustees via Board liaison on a quarterly basis. This is as a standard agenda item)
• Approval and/or specific actions required to achieve approval will be completed within sixty days of receipt by Society for Clinical Data Management Board of Trustees
• Message author will confirm electronically that e-mails have been received
• E-mail responses may be issued by e-mail or fax
• Committee member(s) should be prepared to commit three (3) hours per month on average and secure his/her own management approval for participation
• E-mail responses will be issued to the original distribution list. Distribution list will not be expanded without permission of author(s). Sensitive info will be marked as such and will not be distributed further.
• Take advantage of differences of opinion to examine different sides of an issue
• Incorporate lessons learned

VII: COMMITTEE MEMBERSHIP

• Organizational Diversity:
1. Multi Pharmaceutical
2. CRO(s)
3. Vendor(s) e.g. training organizations
4. Regulatory
• Society for Clinical Data Management BOT
• Multiple levels in organization
• Culturally and geographically diverse
• Certified CDMs

¹ Pitre, A., Charterv4 2000-03-07

Copyright © 2008 Society for Clinical Data Management, Inc. All rights reserved.