Search results
Results From The WOW.Com Content Network
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.
September 1, 1996 - Standards Malaysia officially started its operation at 21st Floor, Wisma MBSA, Shah Alam, Selangor. September 3, 2001 - Standards Malaysia moved its operations from Shah Alam to the Federal Government Administrative Centre in Putrajaya. 2008 - Standards Malaysia moved its operation to Century Square, Cyberjaya.
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.
These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements." [ 1 ] Historically, TMFs have been paper-based content sets stored in physical file cabinets, central file rooms, or shelved in binders.
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; 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.
Fundamentally healthcare and hospital accreditation is about improving how care is delivered to patients and the quality of the care they receive. Accreditation has been defined as "A self-assessment and external peer assessment process used by health care organisations to accurately assess their level of performance in relation to established standards and to implement ways to continuously ...
The Clinical Officers (Training, Registration and Licensing) Act No.20 of 2017 is the law that governs the medical practice of a clinical Officer. [28] It establishes the Clinical Officers Council whose functions are to: advise the government on policy matters relating to clinical medicine practice