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  2. Case report form - Wikipedia

    en.wikipedia.org/wiki/Case_report_form

    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 ...

  3. Monitoring in clinical trials - Wikipedia

    en.wikipedia.org/wiki/Monitoring_in_clinical_trials

    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) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to ...

  4. Phases of clinical research - Wikipedia

    en.wikipedia.org/wiki/Phases_of_clinical_research

    For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.

  5. Investigator's brochure - Wikipedia

    en.wikipedia.org/wiki/Investigator's_brochure

    Investigator's brochure. 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 ...

  6. Template:Event docs - Wikipedia

    en.wikipedia.org/wiki/Template:Event_docs

    The template gives the following sections by default, which you can expand, delete, or modify as needed: Lead: introduce event. Infobox: structured summary of event details, including when/where and social media. Event details: when, where, who, what you will need. Schedule of events: add schedule.

  7. Clinical endpoint - Wikipedia

    en.wikipedia.org/wiki/Clinical_endpoint

    Clinical endpoint. Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then ...

  8. Clinical research - Wikipedia

    en.wikipedia.org/wiki/Clinical_research

    Clinical research is a branch of medical research that involves people and aims to determine the effectiveness ( efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. [1] [2] These research procedures are designed for the prevention, treatment, diagnosis or understanding ...

  9. Clinical pathway - Wikipedia

    en.wikipedia.org/wiki/Clinical_pathway

    Definition. A clinical pathway is a multidisciplinary management tool based on evidence-based practice for a specific group of patients with a predictable clinical course, in which the different tasks (interventions) by the professionals involved in the patient care are defined, optimized and sequenced either by hour (ED), day (acute care) or ...