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Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials
Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. [1] When expressed specifically, a clinical trial phase is capitalized both in name and Roman numeral, such as "Phase I" clinical trial. [1]
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 ...
An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial. This understanding should be based on the ...
A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed. [ 1 ] A vaccine candidate drug is first identified through preclinical evaluations that could involve high throughput screening and selecting the proper antigen to invoke an immune response.
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.
A randomized controlled trial (or randomized control trial; [2] RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments. [3] [4]
The term "Clinical research center" (CRC) or "General clinical research center" (GCRC) refers to any designated medical facility used to conduct clinical research, such as at a hospital or medical clinic. [1] They have been used to perform clinical trials of various medical procedures. The medical profession has had specific uses for CRC ...