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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]
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice. This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
Academy of Veterinary Technicians in Clinical Practice AVTCP ... Certified Cost Professional: CCP: ... Registered Quality Assurance Professional in Good Clinical ...
It defines Good Clinical Practice (GCP), which is an agreed quality standard that governments can transpose into regulations for clinical trials involving human subjects. [16] Here is a summary of several key regulatory guidelines for oversight of clinical trials: Safeguard the rights, safety, and well-being of all trial subjects.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [ 2 ] as:
Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA)) Inspection and conformity assessment of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Practice Systems and Programs (GPSP)
ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline (and see Clinical Quality Management System) Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0-8247-4614-7 Juran, Joseph M. and De Feo, Joseph A., "Juran's Quality Handbook", 6th Edition, 1999, ISBN 978-0-07-162973-7
In the United States, the rules of good clinical practice are codified in Title 21 of the Code of Federal Regulations. [9] CNNMoney listed Clinical Research Associate at #4 on their list of the "Best Jobs in America" in 2012, with a median salary of $90,700. [10]
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