Good Clinical Data Management Practice

Good Clinical Data Management Practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes. The FDA and ICH have provided specific regulations and guidelines surrounding this component of the drug and device development process. The effective, efficient and regulatory-compliant management of clinical trial data is an essential component of drug and device development.

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The Society of Clinical Data Management (SCDM [1]) has created a comprehensive document that provides guidance on accepted practices of clinical data management (CDM) that are not totally covered by current guidelines and regulations. This document is entitled Good Clinical Data Management Practices (GCDMP) and version 4.0 was most recently published in May 2007.

References

• COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS, U.S. Department of Health and Human Services, Food and Drug Administration

Center for Biologic Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Food Safety and Nutrition (CFSAN), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), April 1999 [2]

• Title 21 Code of Federal Regulations (21 CFR Part 11), Electronic Records; Electronic Signatures, Final Rule Published in the Federal Register, Web page issued: March, 2000; reformatted June 01, 2001 (with updated email addresses for FDA contacts) [3]

See also

• Good clinical practice
• GxP