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2. Electronic data capture - Wikipedia

   en.wikipedia.org/wiki/Electronic_data_capture

   Electronic data capture. An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and ...

3. Clinical trial - Wikipedia

   en.wikipedia.org/wiki/Clinical_trial

   A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...

4. Phases of clinical research - Wikipedia

   en.wikipedia.org/wiki/Phases_of_clinical_research

   Phases of clinical research. 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 ...

5. Electronic trial master file - Wikipedia

   en.wikipedia.org/wiki/Electronic_trial_master_file

   An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

6. ClinicalTrials.gov - Wikipedia

   en.wikipedia.org/wiki/ClinicalTrials.gov

   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.

7. Good clinical practice - Wikipedia

   en.wikipedia.org/wiki/Good_clinical_practice

   Good clinical practice. In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals ...