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Clinical governance is a systematic approach to maintaining and improving the quality of patient care within the National Health Service (NHS) and private sector health care. Clinical governance became important in health care after the Bristol heart scandal in 1995, during which an anaesthetist, Dr Stephen Bolsin , exposed the high mortality ...
The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for ...
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
Nursing ethics is a branch of applied ethics that concerns itself with activities in the field of nursing.Nursing ethics shares many principles with medical ethics, such as beneficence, non-maleficence and respect for autonomy.
It was established by the Government of the Punjab under the Punjab Healthcare Commission Act 2010. [2] The PHC is responsible for developing and enforcing Minimum Service Delivery Standards (MSDS) at all levels of healthcare, to improve the quality of healthcare services and foster a culture of Clinical Governance.
Clinical peer review, also known as medical peer review is the process by which health care professionals, including those in nursing and pharmacy, evaluate each other's clinical performance. [ 1 ] [ 2 ] A discipline-specific process may be referenced accordingly (e.g., physician peer review , nursing peer review ).
The Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed in the USA subsequent to the publication of an article in November 1987 in The Wall Street Journal entitled "Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Labs Errors", which alerted the public to the fact that a pap smear may be falsely negative.
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. The size and complexity ...