Unique Skill ID: KS121ZZ72H24DRC50WNL

Clinical Trials

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

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Case Report Forms
Clinical Research
Clinical Trial Management Systems
Drug Development
Electronic Data Capture (EDC)
Good Clinical Practices (GCP)
ICH Guidelines
Pharmacovigilance
Pre-Clinical Development
Regulatory Documents

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