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European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
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.
Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
The GCP tool was developed by Dr. Srivastava, a Consultant Paediatrician and designated doctor for child protection. It was the subject of his research at the University of Nottingham which got published in 1997 (Ref:5). In 1999, the GCP tool began being used by the Luton Borough Council and by Luton Health Trust professionals. Since then, its ...
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
Week 14 of college football action is underway, and the outcomes of Saturday's games are set to significantly impact the College Football Playoff, with 20 of the top 25 teams in action.This ...
Related: Shark Tank's Barbara Corcoran Recalls Caregiving for Her Mom with Alzheimer’s: 'Grieving in Slow Motion' (Exclusive) Alzheimer’s is the most common type of dementia, the U.S. Centers ...
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials.
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