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The ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of all members, including administrative and financial matters and oversight of the working groups (WGs). [citation needed] The MedDRA Management Committee (MC) is responsible for direction of MedDRA, ICH's standardised medical terminology.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [1] [2] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [3] and Switzerland. [1]
A source document is a document in which data collected for a clinical trial is first recorded. This data is usually later entered in the case report form.The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH-GCP) guidelines define source documents as "original documents, data, and records."
Documentation requirements for the set-up and maintenance of quality systems, electronic systems, safety monitoring, and proof of an adequate and well-controlled trial, to name a few, exist in various regulations across many countries or regions, but are not explicitly described in ICH GCP E6.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal [1] —used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.
Health information management's standards history is dated back to the introduction of the American Health Information Management Association, founded in 1928 "when the American College of Surgeons established the Association of Record Librarians of North America (ARLNA) to 'elevate the standards of clinical records in hospitals and other medical institutions.'" [3]