Clinical Study definition

Clinical Study means a Phase I Study, Phase II Study (including a Phase II(a) and Phase II(b) Study), Phase III Study or Post-Approval Studies, as applicable.

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

Examples of Clinical Study in a sentence

• Refer to the Clinical Study Agreement for location of source data.

• A detailed description of the planned TFLs to be presented in the Clinical Study Report (CSR) is provided in the accompanying TFL shell document.

• In the event of any inconsistency between this protocol and the Clinical Study Agreement, the terms of protocol shall prevail with respect to the conduct of the study and the treatment of subjects and in all other respects, not relating to study conduct or treatment of subjects, the terms of the Clinical Study Agreement shall prevail.

• Any deviations from the analysis planned in SAP will be justified in the Clinical Study Report.

• Licensor hereby represents and warrants to Xxxxxxx, as of the Execution Date, that (a) to the best of Licensor’s knowledge following reasonable inquiry by Licensor’s personnel responsible for supply chain and quality matters, all information contained in the Certificate, including all information regarding the Specified Phase 1 Materials, is true, complete and correct in all respects and (b) none of the Specified Additional Materials has been used in any Clinical Study or otherwise dosed to any person.

More Definitions of Clinical Study

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.

Clinical Study means any study in which human subjects are dosed or treated with a drug or biological product, whether approved or investigational.

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

Clinical Study means any investigation in relation to humans intended:

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

Clinical Study means a clinical study in human subjects that has been approved by a Regulatory Authority and applicable institutional review board or ethics committee, and is designed to measure the safety and/or efficacy of a Licensed Product. Clinical Studies shall include, but not be limited to, Phase I Studies, Phase II Studies, Phase III Studies and any clinical studies required to be conducted by any Regulatory Authorities following receipt of Regulatory Approval.

Clinical Study or “Clinical Studies” means any experiment that involves a test biological product, drug or device and one or more human subjects and that either is subject to requirements for prior submission to a Regulatory Authority or is not subject to requirements for prior submission to a Regulatory Authority but the results of which are intended to be submitted later to, or held for inspection by, a Regulatory Authority as part of an application for a research permit or Regulatory Approval, and includes studies relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the biological product, drug or device.