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A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment.
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 ...
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
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 ...
The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guidance, the term protocol refers to protocol and protocol amendments. (ICH E6) Protocol Amendment A written description of a change(s) to or formal clarification of a protocol ...
This page is an attempt to establish such a research protocol. It takes the form of a pledge or agreement between the ethnographer and the Wikipedian community. It is not the only possible research protocol, but it can be used by any researcher who wishes to ethically research Wikipedia by actively interacting with the community.
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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.