Clinical Trial definition

Clinical Trial means any human clinical trial of a Product.
Clinical Trial means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a) establish that a pharmaceutical product is reasonably safe for continued testing, (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed or (c) support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product.

Examples of Clinical Trial in a sentence

  • The European Medicines Agency (EMA) published a recommendation paper, which outlines areas for risk adaptation with regard Clinical Trial Oversight and EudraVigilance To ensure appropriate oversight of clinical trials the EU CTR extends the reporting requirements (see sec- tion additional reporting requirements).

  • Pennine Lancashire CCGs are fully committed to the standards set out in the RGF, the Clinical Trial Regulations and other relevant legislation, and to implementing the NIHR Research Support Services framework locally.

  • On the other hand, the VHIO shall invoice all of the other amounts of the Clinical Trial that do not correspond to ‘overheads’ or indirect costs indicated in the previous section, particularly, the net amount for the management of the Principal Investigator.

  • Separately, please be advised that the State Claims Agency released an updated Clinical Trial Indemnity Form on the 18th August2021 https://www.beaumontethics.ie/application/indemnity.htm 2.

  • Specifically, all of those amounts destined to cover indirect costs or ‘overheads’ of the Clinical Trial.


More Definitions of Clinical Trial

Clinical Trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Clinical Trial means the investigation to be conducted at the Trial Site in accordance with the Protocol numbered […insert identification number…].
Clinical Trial means a study in humans that is conducted in accordance with GCP and is designed to generate data in support of an NDA.