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The PRISMA flow diagram, depicting the flow of information through the different phases of a systematic review. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, primarily used to assess the benefits and harms of a health care ...
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. [ 1 ]
The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
The ICH secretariat is located in Geneva, Switzerland. [citation needed] The ICH WGs are established by the assembly when a new technical topic is accepted for harmonisation, and are charged with developing a harmonised guideline that meets the objectives outlined in the concept paper and business plan.
A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
The STROBE Statement has also been adapted as a public, open-source repository for epidemiological research methods and reporting skills for observational studies. Epidemiologists, statisticians, and public health researchers are able to comment and edit the tool to inform future updates of the reporting guideline. [27]
The main product of the CONSORT Group is the CONSORT Statement, [1] which is an evidence-based, minimum set of recommendations for reporting randomized trials.It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and interpretation.