Embark on a journey of knowledge! Take the quiz and earn valuable credits.
Challenge yourself and boost your learning! Start the quiz now to earn credits.
Unlock your potential! Begin the quiz, answer questions, and accumulate credits along the way.
What is Clinical Study Report mean?
In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. Results of trials are usually reported in a briefer academic journal paper, but methodological flaws are often glossed over in the briefer paper.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a body bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration; in 1995 it produced a tripartite harmonised ICH guideline on the format and content of a study report to be acceptable in all three ICH regions. Recommended prerequisites and content for producing a report conformant to ICH guidelines have been outlined by SE Caldwell. In the Nov 9, 2016 addendum to the ICH guidelines Canada and Switzerland were added to the countries which would accept the unified standard.
referencePosted on 30 Apr 2022, this text provides information on Miscellaneous in Governmental related to Governmental. Please note that while accuracy is prioritized, the data presented might not be entirely correct or up-to-date. This information is offered for general knowledge and informational purposes only, and should not be considered as a substitute for professional advice.
Turn Your Knowledge into Earnings.
Ever curious about what that abbreviation stands for? fullforms has got them all listed out for you to explore. Simply,Choose a subject/topic and get started on a self-paced learning journey in a world of fullforms.
Write Your Comments or Explanations to Help Others