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A guideline is a statement by which to determine a course of action. It aims to streamline particular processes according to a set routine or sound practice. [1] They may be issued by and used by any organization (governmental or private) to make the actions of its employees or divisions more predictable, and presumably of higher quality.
Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.
It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors.
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The WHO Smart Guidelines are part of a broader global trend of digitizing clinical guidelines to make them more actionable in healthcare systems. For example, the Centers for Disease Control and Prevention (CDC) in the United States developed the "Adapting Clinical Guidelines for the Digital Age" (ACG) initiative, which promotes a holistic ...
The guidelines were developed to aid reading comprehension in the social and behavioral sciences, for clarity of communication, and for "word choice that best reduces bias in language". [ 1 ] [ 2 ] APA style is widely used, either entirely or with modifications, by hundreds of other scientific journals , in many textbooks, and in academia (for ...
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP. A "c" or "C" is sometimes added to the front of the initialism.