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The International Clinical Trials Registry Platform (ICTRP) is a platform for the registration of clinical trials operated by the World Health Organization. [1]The ICTRP combines data from multiple cooperating clinical trials registries to generate a global view of clinical trials worldwide, with a search portal that allows access to the entire dataset.
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A trial record manager typically provides initial trial registration prior to the study enrolling the first participant. This also facilitates informing potential participants that the trial is no longer recruiting participants. Once all participants were recruited, the trial record may be updated to indicate that is closed to recruitment.
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 ...
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The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time 'snapshot' of a patient's physical condition to hundreds of pages of electronically captured data obtained over a period of weeks ...
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A Phase IV trial is also known as a postmarketing surveillance trial or drug monitoring trial to assure long-term safety and effectiveness of the drug, vaccine, device or diagnostic test. [1] Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives regulatory approval to be ...