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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.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The Research Quality Association (RQA) is a not for profit membership association.Formerly known a Quality Assurance Group UK (QAG UK) and the British Association of Research Quality Assurance (BARQA), the association changed its name to RQA in December 2012 in order to be able to act in a more global role.
The Healthcare Information and Management Systems Society (HIMSS) is an American not-for-profit organization dedicated to improving health care in quality, safety, cost-effectiveness and access through the best use of information technology and management systems. It was founded in 1961 as the Hospital Management Systems Society.
Created in 1999, the CIP program is a result of many years of discussions and planning by organizational members and leaders. It is endorsed by federal regulatory officials, professional associations, many national advisory bodies and IRB professionals who are committed to improving the quality of human research protection programs.
Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (ECHA) Made by: European Parliament and Council: Made under: Art. 95 (EC) Journal reference: L396, 30.12.2006, pp. 1–849: History; Date made: 18 December 2006: Entry into force: 1 June 2007 ...
The IMS/ASA Spring Research Conference (SRC) is an annual conference sponsored by the American Statistical Association (ASA) Section on Physical and Engineering Sciences (SPES) [1] and the Institute of Mathematical Statistics (IMS). [2] The goal of the SRC is to promote cross-disciplinary statistical research in engineering, science and technology.
A number of research practices such as p-hacking, publication bias, data dredging, inappropriate forms of post hoc analysis, and HARKing may increase the probability of incorrect claims. Although the idea of preregistration is old, [ 9 ] the practice of preregistering studies has gained prominence to mitigate to some of the issues that are ...