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 trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
, clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes. The
U.S. Food and Drug Administration and
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.
The Society for Clinical Data Management (SCDM) has created the Good Clinical Data Management Practices (GCDMP©) standard,
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 updated by Subject Matter Experts on a continuous basis.
See also
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U.S. Department of Health and Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
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Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
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Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, ...
(CBER),
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also l ...
(CDER),
Center for Devices and Radiological Health
The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safe ...
(CDRH),
Center for Food Safety and Nutrition
The Center for Food Safety and Applied Nutrition (CFSAN ( )) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products.
...
(CFSAN),
Center for Veterinary Medicine
The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from whic ...
(CVM),
Office of Regulatory Affairs
The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supple ...
(ORA).
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Good clinical practice
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GxP
References
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External links
Title 21 Code of Federal Regulations (21 CFR Part 11), Electronic Records; Electronic Signatures, Final Rule Published in the Federal Register
Clinical research
Clinical data management
Good practice