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The GCDMP is provided as a special service to the SCDM membership. The primary recipients include professionals involved in the pharmaceutical, biotechnology, and medical device clinical data management. It will provide assistance to data managers in their implementation of high quality data management processes and in their quest to become Certified Clinical Data Managers (CCDM). It will also provide management with a guide for planning training and education for new clinical data management staff.
Acknowledgements
As the committee chairperson, I would like to acknowledge the expertise, dedication and hard work of the document authors. The following individuals have contributed to one or more versions of the GCDMP: Susan Bornstein, Letitia Bowen, Sally Cassells, Anthony J. Costello, Wendy Cuthbert, Bernadette Farrell, Kaye Fendt, Lisa Freeman, Volker Freiman, Imogene Grimes, Marysasser Hedrick Holloway, Susan Howard, Becky Kush, Angel Lazarov, Terrence Loding, Meredith Nahm, Armelde Pitre, Don Rosen, Barbara Tardiff, Lisa Taylor, and Beth Wilson. In addition, Sasha Zucker provided his knowledge and skills as technical editor, for which we are most grateful. While I spearheaded the effort to update the Lifetime Maintenance Plan, Susan Howard led the Review and Update subcommittee, which dedicated its efforts to reviewing existing chapters and incorporating feedback from users. I would also like to acknowledge the GCDMP Full Committee, which has provided insight and expertise during the review of the new and revised chapters. Kaye Fendt—who initially took the idea of this committee to the Board of Trustees and to interested members of SCDM and who served as Board and FDA Liaison in its early years—has continued to lend her expertise to this committee as an innovator, an author, an editor, a supporter, and a motivator. Susan Bornstein led the committee during its formation and coordinated the creation of the CDM Task List, which served as the basis for the organization of this document. Meredith Nahm chaired the committee through 2001, served as Board Liaison through 2004, and has continued to contribute to the review process. Anthony Costello, who is currently Chair of the Board of Trustees and served as Board Liaison through 2006, continues to bring driven energy and focus on exposure and training of the document to the committee.
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We are most grateful to all of you for your contributions and dedication. Carol Garvey, GCDMP Committee Chair
Linda Talley, Board of Trustees Liaison
Introduction
The purpose of this document is to provide guidance on accepted practices for the many areas of CDM that are not covered by existing regulations and guidance documents. The intent is to remain consistent with regulatory practices in related areas of clinical research and to apply the concepts contained in those regulations and associated guidance documents to CDM. It is also the intent of the GCDMP to provide practical suggestions and proven means of meeting the guidelines recommended in the GCDMP. The GCDMP is written to serve the needs of multiple audiences including: data managers, data processors, statisticians, site personnel, clinical professionals, compliance auditors, regulatory affairs personnel, and all clinical research professionals making decisions regarding or using clinical trial data.
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