Clinical Trials definition
Clinical TrialsÌýmeans a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.
Clinical TrialsÌýmeans Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Phase 4 Trials, and/or variations of such trials (for example, Phase 3/4).
Clinical TrialsÌýmeans trials that: 1) have been subjected to independent peer-review of the rationale and methodology; 2) are sponsored by an entity with a recognized program in clinical research that conducts its activities according to all appropriate federal and state regulations and generally accepted standard operating procedures governing the conduct of participating investigators; and 3) the results of which will be reported upon completion of the trial regardless of their positive or negative nature.
Examples of Clinical Trials in a sentence
The Institute of Clinical Research, Abbreviations used in Clinical Trials.
Clinical Trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
Where you are asked for your consent to take part in Research, Clinical Trials or Audits, your care will not be affected if you decline to take part.
Site pharmacists should consult the Pharmacy Guidelines and Instructions for DAIDS Clinical Trials Networks for standard pharmacy operations.
Good Clinical Practices-Guidelines for Clinical Trials on Pharmaceutical Products in India.
More Definitions of Clinical Trials
Clinical TrialsÌýmeans human studies designed to measure the safety and/or efficacy of the Product. Clinical Studies include Phase I Clinical Trials, Phase II Clinical Trials, and Phase III Clinical Trials.
Clinical TrialsÌýmeans Phase I Clinical Trials, Phase II Clinical Trials or Phase III Clinical Trials, as applicable.
Clinical TrialsÌýmeans any or all of the Phase I Clinical Trials, Phase II Clinical Trials or Phase III Clinical Trials.
Clinical TrialsÌýmeans a clinical trial in human subjects that has been approved by a Regulatory Authority and an institutional review board or ethics committee, and is designed to measure the safety and/or efficacy of a Licensed Product. Clinical Trials shall include Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials and any pre-clinical or post-Regulatory Approval studies undertaken in relation to any Licensed Product.
Clinical TrialsÌýmeans the use of any Product in the Field in connection with testing or evaluation of such Product or in connection with a process to obtain Regulatory Approval to market the Product.
Clinical TrialsÌýmeans any clinical studies of a Licensed Product conducted on humans.
Clinical TrialsÌýmeans a human clinical trial intended to support the regulatory approval or commercialization of a given pharmaceutical or biologic product.