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The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events . The sponsor of the clinical trial develops the CRF to collect the specific data they need in ...
Patient-reported outcome. A patient-reported outcome ( PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician -reported outcome, a nurse -reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other ...
Evidence-based practices. A hierarchy of evidence, comprising levels of evidence ( LOEs ), that is, evidence levels ( ELs ), is a heuristic used to rank the relative strength of results obtained from experimental research, especially medical research. There is broad agreement on the relative strength of large-scale, epidemiological studies.
Headquarters. Bethesda, Maryland, U.S. Agency executive. Rebecca J. Williams, Director. Website. ClinicalTrials.gov. ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and holds registrations from over 444,000 trials from 221 countries.
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. [1] For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study ...
Patient diary. A patient diary is a tool used during a clinical trial or a disease treatment to assess the patient's condition (e.g. symptom severity, quality of life) or to measure treatment compliance. An electronic patient diary registers the data in a storage device and allows for automatically monitoring the time the entry was made.
Clinical data management ( CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and ...
An electronic patient-reported outcome ( ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process.