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The sharing of research outputs is covered by three standards of the TOPs guidelines: on Data transparency (2), Analytic/code methods transparency (3) and Research materials transparency (4). All the relevant data, code and research materials are to be stored on a "trusted repository" and all analysis being already reproduced independently ...
Requirements for data sharing are more commonly imposed by institutions, funding agencies, and publication venues in the medical and biological sciences than in the physical sciences. Requirements vary widely regarding whether data must be shared at all, with whom the data must be shared, and who must bear the expense of data sharing.
In fact, the Code's reference to Hippocratic duty to the individual patient and the need to provide information was not initially favored by the American Medical Association. [13] Katz observes that the Western world initially dismissed the Nuremberg Code as a "code for barbarians, but unnecessary (or superfluous) for ordinary physicians."
The standards support medical research from protocol through analysis and reporting of results and have been shown to decrease resources needed by 60% overall and 70–90% in the start-up stages when they are implemented at the beginning of the research process. [1] Since December 2016, CDISC standards are mandatory for submission to US FDA. [2 ...
Syntactic interoperability, provided by for instance XML or the SQL standards, is a pre-requisite to semantic. It involves a common data format and common protocol to structure any data so that the manner of processing the information will be interpretable from the structure.
The acronym "SMART" stands for Standards-based, Machine-readable, Adaptive, Requirements-based, and Testable, which outlines the structured approach used to translate traditional health guidelines into formats suitable for digital health systems.: [1] The objective of SMART guidelines is to promote adaptation of WHO guidelines while preserving ...
An open-source license is a type of license for computer software and other products that allows the source code, blueprint or design to be used, modified or shared (with or without modification) under defined terms and conditions.
Randomized controlled trial [5]. Blind trial [6]; Non-blind trial [7]; Adaptive clinical trial [8]. Platform Trials; Nonrandomized trial (quasi-experiment) [9]. Interrupted time series design [10] (measures on a sample or a series of samples from the same population are obtained several times before and after a manipulated event or a naturally occurring event) - considered a type of quasi ...