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In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment.Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories.
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 ...
A style guide, or style manual, is a set of standards for the writing and design of documents, either for general use or for a specific publication, organization or field. The implementation of a style guide provides uniformity in style and formatting within a document and across multiple documents.
A clinical trial protocol is a document used to define and manage the trial. It is prepared by a panel of experts. All study investigators are expected to strictly observe the protocol. [citation needed] The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations and organization of the planned ...
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 ...
Examples of data that would lead to a query: a male patient being on female birth control medication or having had an abortion, or a 15-year-old participant having had hip replacement surgery. Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration.
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The use of a sequence of experiments, where the design of each may depend on the results of previous experiments, including the possible decision to stop experimenting, is within the scope of sequential analysis, a field that was pioneered [12] by Abraham Wald in the context of sequential tests of statistical hypotheses. [13]