Clinical Study definition

Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 1/2 Study, Phase 2 Study, Phase 2/3 Study or a Phase 3 Study, or other study (including a non-interventional study) in humans to obtain information regarding a product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

Examples of Clinical Study in a sentence

• Subject to clause 10.3 above, the Sponsor agrees that the Site Investigator and/or members of the Research Staff shall be permitted to present at symposia, national or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise of its own choosing, methods and results of the Clinical Study, subject to the terms of this clause 10 and of any publication policy described in the Protocol, provided any such policy does not obstruct publication unreasonably.

• The Study Site will ensure the availability of and/or access to any resources necessary to perform the Clinical Study at the Study Site, including departments, facilities and Research Staff and support personnel, and the Study Site certifies (in Dutch: “verklaart”) that the Site Investigator holds the necessary registration and has the necessary qualifications, expertise and time to perform the Clinical Study.

• Site Parties shall promptly notify Sponsor of any withdrawal of or changes in the informed consent of a Clinical Study Subject, which may affect the use of such Clinical Study Subject’s Samples under this Agreement.

• Site Investigator shall make sure that the Clinical Study Subjects (and/or their legal representatives, if applicable) will, in accordance with applicable Law, be duly informed prior to their participation in the Clinical Study, in a language the Clinical Study Subjects (and/or their legal representatives, if applicable) can fully understand on all aspects of the Clinical Study which are deemed relevant in their decision to participate, and give informed consent.

• In consideration of the undertakings and commitments set forth herein, the Parties agree to enter into this Clinical Study Site Agreement.

More Definitions of Clinical Study

Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

Clinical Study means any human clinical trial of a Product Candidate.

Clinical Study means a study in which human subjects or patients are dosed with a drug, whether approved or investigational.

Clinical Study means any investigation in relation to humans intended:

Clinical Study means a research study using human subjects to evaluate biomedical or health-related outcomes, including a Phase 1 Study, a Phase 2 Study, a Phase 3 Study, a phase 4 study or post-approval study, an observational study, or variations of such studies (e.g., Phase 2/3).

Clinical Study means a Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational.

Clinical Study means the investigation as defined in the cadre above, (also) to be conducted at the Study Site in accordance with the Protocol;