Clinical Studies definition

Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

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 Studies means all Clinical Phase I Studies, Clinical Phase II Studies and Clinical Phase III Studies, including pivotal studies.

Examples of Clinical Studies in a sentence

• The Clinical Studies Course will be given in the classroom by a qualified instructor or a Registered Holistic Nutritionist.

• Each party shall be independently responsible for its own HIPAA compliance and obligations (for example, minimum necessary requirements, or accounting of disclosures of PHI made pursuant to a waiver of authorization) in connection with the Clinical Studies included in this Agreement other than the initial determinations regarding mechanisms for use and disclosure of PHI referenced in this Section III.3.

• ABC will accept the decisions and requirements of the Central IRB with respect to the Clinical Studies included in this Agreement.

• In the event of any required reporting to sponsors/funding agencies, OHRP, FDA, and/or other oversight authorities of unanticipated problems involving risks to subjects or others, serious or continuing non-compliance, and suspension or termination of IRB approval in connection with the Clinical Studies included in this Agreement, ABC and the Central IRB will work together to determine which one of them will make the report.

• The Central IRB will perform initial review and continuing oversight of the Clinical Studies included in this Agreement in accordance with the human subjects protection requirements of ABC’s OHRP- approved FWA and the federal regulations and ethical principles referenced therein.

More Definitions of Clinical Studies

Clinical Studies means Phase I, Phase II, Phase III, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise conducted or recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the approved indications for such Licensed Product.

Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

Clinical Studies means any human clinical study or clinical trial of a Licensed Product.

Clinical Studies means a research study in humans that is (a) conducted in accordance with international ethical and scientific quality standards for designing, conducting, recording and reporting research studies involving investigational medicinal products for human use and that involve the participation of human subjects, which standards are established through Laws, and (b) designed to generate clinical data and results regarding a chemical compound or biological molecule in support of Marketing Approval, including any translational research studies. Clinical Studies include any Phase 1 Clinical Study(ies), any Phase 2 Clinical Study(ies), any Phase 3 Clinical Study(ies) or any Phase 4 Clinical Study(ies).

Clinical Studies means any study in which human subjects are dosed with a drug, whether approved or investigational, including any Phase 1, 2, 3 or 4 clinical study.

Clinical Studies means Phase 0, Phase I, Phase II, Phase III, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more Indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such Indication.