The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings.
The method, procedure, or measurement that is widely accepted as being the best available, against which new developments should be compared.
|Good Clinical Practice||
Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
|Good Manufacturing Practice||
GMP is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification.
|Governance Arrangements for Research Ethics Committees||
A policy document has been written by the UK Health Departments describing what is expected from the research ethics committees that review research proposals relating to areas of the UK Health Department’s responsibility.
Grey literature is material that is less formal than an article in a peer review journal or a chapter in a book so it’s not easily tracked down. It includes internal reports, committee minutes, conference papers, factsheets, newsletters and campaigning material. However, ‘grey literature’ may be made available on request and is increasingly available on the Internet.