Clinical Trials definition

Clinical Trials means 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 Trials means Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Phase 4 Trials, and/or variations of such trials (for example, Phase 3/4).
Clinical Trials means 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 Trials means 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 Trials means a Phase II Clinical Trial or a Phase III Clinical Trial.
Clinical Trials means any and all human clinical trial of a compound, including without limitation Phase 1 Clinical Trials, Phase 2 Clinical Trials, Phase 3 Clinical Trials, Phase 4 Clinical Trials, bioequivalence trials, and/or variations of such trials (for example, phase 2/3 studies).
Clinical Trials means any or all of the Phase I Clinical Trials, Phase II Clinical Trials or Phase III Clinical Trials.
Clinical Trials means any administration of Licensed Products to humans for the purpose of demonstrating the safety or efficacy of the Licensed Product.
Clinical Trials means any clinical studies of a Licensed Product conducted on humans.
Clinical Trials means use of the Product for the purpose of conducting human studies to determine the safety, efficacy or other characteristics for clinical development of the Product for the purpose of seeking pharmaceutical regulatory approval.