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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties ...
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.
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."
London — A Michelin-starred chef in England called Monday on the thieves who stole his work van, along with about $32,000 worth of meat pies inside it, to embrace the holiday spirit and hand ...
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.
Twelve percent of parents worry that their child’s anger will cause problems, according to a new poll. Experts weigh in on tips to manage their frustrations.
A leaked video of UnitedHealth CEO Andrew Witty defending claim denials after Brian Thompson’s murder has sparked backlash. Critics argue the policy contributes to medical bankruptcies and lives ...