Clinical Investigator definition

Clinical Investigator means, in accordance with 21 C.F.R. § 312.3, an individual who actually conducts a clinical investigation, that is, who directs the administration or dispensation of Test Article to a subject, and who assumes responsibility for studying Human Subjects, for recording and ensuring the integrity of research data, and for protecting the welfare and safety of Human Subjects.

Clinical Investigator means only a listed or identified investigator or sub- investigator who is directly involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each dependent child of the investigator.

Clinical Investigator means the principal investigator at each Site.

Examples of Clinical Investigator in a sentence

• Responsibilities of the Clinical Investigator Clinical research studies sponsored by AbbVie are subject to the Good Clinical Practices (GCP) and local regulations and guidelines governing the study at the site location.

• The Chief Investigator (Mr Paul Mouncey) and the Lead Clinical Investigator (Dr Francois Lamontagne) will take overall responsibility for delivery of the 65 Trial and oversee progress against timelines/milestones.

• Prior to study start, the Clinical Investigator is required to sign a protocol signature page confirming his/her agreement to conduct the study in accordance with these documents and all of the instructions and procedures found in this protocol and to give access to all relevant data and records to the sponsor.

• In addition, IVRs and NPIVRs must list all clinical practice sites and IRBs covering their practice sites on the FDA Form 1572 in RCR to allow the following:• Added to a site roster• Assigned the treating, credit, consenting, or drug shipment (IVR only) tasks in OPEN• Act as the site-protocol PI on the IRB approval• Assigned the Clinical Investigator (CI) role on the Delegation of Tasks Log (DTL).

• The Career Development Plan should describe the course of action the Applicant will take over the 3-year grant period to obtain the necessary training to serve as a Clinical Investigator.

More Definitions of Clinical Investigator

Clinical Investigator means an em- ployee identified as a principal investi- gator, accountable investigator, lead associate investigator, medical advi- sory investigator, associate investi- gator, or other subinvestigator in an NIH clinical study involving human subjects under a clinical research pro- tocol approved by an institutional re- view board.

Clinical Investigator means, in accordance with 21 C.F.R. § 312.3, an individual who directs the administration or dispensation of Agent to a Human Subject, and who assumes responsibility for studying the Human Subjects under the Protocol, for recording and ensuring the integrity of research data, and for protecting the welfare and safety of Human Subjects, at a Clinical Research Site.

Clinical Investigator means a listed or identified investigator or subinvestigator for the Study who is directly involved in the treatment or evaluation of research subjects and such investigator’s spouse and each dependent child of such investigator.

Clinical Investigator means an employee identified as a principal investigator, accountable investigator, lead associate investigator, medical advisory investigator, associate investigator, or other subinvestigator in an NIH clinical study involving human subjects under a clinical research protocol approved by an institutional review board.

Clinical Investigator with respect to any Project shall mean a licensed physician who is a qualified clinical investigator willing and able, and engaged by Numoda or Advaxis, in accordance with this Agreement and a Project Agreement (hereinafter defined), to conduct a clinical investigation of a Compound as set forth in the Protocol for the Project.

Clinical Investigator. Section 8.5

Clinical Investigator means a listed or identified investigator or subinvestigator for the Study who is directly involved in the treatment or evaluation of research subjects and such investigator’s spouse and each dependent child of such investigator. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.