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A document written before a clinical trial which is followed throughout the study. The protocol describes the objectives, design, methodology and organisation of a trial, carefully taking into account the health and safety of participants as well as answer specific research questions.
See also:
Clinical trial
Methodology
Research and development (R&D)
Generic medicine, Drug usage/utilisation review (DUR), Recruitment status, Open-label trial, Compassionate use, Inclusion/exclusion criteria, Indication, Pre-clinical trials, Placebo-controlled trial, Drop out, Peer review, Recruiting, Risk-benefit analysis, Pharmaceutical Researchers and Manufacturers of America (PhRMA), Investigational new drug (IND),
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