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The STROBE Statement was developed by the STROBE Initiative, an international collaboration of epidemiologists, methodologists, statisticians, researchers and journal editors with the aim to assist authors when writing up analytical observational studies, to support editors and reviewers when considering such articles for publication, and to help readers when critically appraising published ...
Geoscience Reporting Guidelines—for geoscience reports in industry, academia and other disciplines. [30] Handbook of Technical Writing, by Gerald J. Alred, Charles T. Brusaw, and Walter E. Oliu.—for general technical writing. IEEE style—used in many technical research papers, especially those relating to computer science.
A protocol may also reference applicable laws and regulations that are applicable to the procedures described. Formal protocols typically require approval by one or more individuals—including for example a laboratory directory, study director, [11] and/or independent ethics committee [12]: 12 —before
In the standard preregistration format, researchers prepare a research protocol document prior to conducting their research. Ideally, this document indicates the research hypotheses, sampling procedure, sample size, research design, testing conditions, stimuli, measures, data coding and aggregation method, criteria for data exclusions, and statistical analyses, including potential variations ...
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 ...
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
R.J. Hottovy, head of analytical research at Placer.ai, added, "We’re starting to see a bit of a comeback in those door-busters we saw once upon a time." However, ...
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 ...