Site Principal Investigator definition

Site Principal Investigator is an individual who has primary responsibility for the conduct of a multicenter human subjects research study at a particular site or institution. Unless the site principal investigator is also the overall principal investigator for a multicenter study, the site principal investigator will be associated with an institution that has ceded IRB review of the study to the IRB of another institution.
Site Principal Investigator means The individual taking responsibility for the conduct of the Study at the Clinical Centre
Site Principal Investigator means the Site Principal Investigator is the investigator at a Member who will lead the Study at that Institution.

Examples of Site Principal Investigator in a sentence

  • After execution of this Agreement, if the Study Site becomes aware that the Study Site, Principal Investigator or any employee has been, or is in the process of being charged, convicted, debarred, disqualified or excluded in accordance with the aforementioned provisions, the Study Site hereby certifies it will promptly notify DSI in writing during the term of this Agreement and for three (3) years following its termination or expiration.

  • GCP training (TransCelerate-recognised) will be/has been completed by each Site Principal Investigator and will be strongly recommended for trial coordinators.

  • In the design special attention shall be paid to the individual safety of the subject and adjacent structures, as well as to the safety and stability of the entire area in connection with the feasibility to implement any individual stage.

  • Study Site certifies that neither the Study Site, Principal Investigator nor any person directly employed by them in the performance of the Study has been charged or convicted of a federal or state offense (related to healthcare services or to his/her medical license), debarred or disqualified from participating in clinical research by any regulatory authority for debarment or any similar regulatory action in any country.

  • The Site Principal Investigator (PI; usually the lead GP for the study at that centre) retains overall responsibility for the conduct of research at their site; this includes the taking of informed consent of participants at their site.

  • Reporting will be done in a timely manner (Site Principal Investigator to report to the coordinating principal Investigator within 72 hours and to the Site research governance office within 7 day; CPI to review and submit to the approving ethics committee within 7 days).

  • The Sponsor will conduct a site visit to verify the qualifications of each Investigator, inspect the site facilities, and inform the Investigators of responsibilities and the procedures for ensuring adequate and correct documentation.The Trial Site Principal Investigator of each trial site will conduct a site visit to verify the qualifications of each Investigator.

  • The Site Principal Investigator (PI) should inform the Sponsor of any known or anticipated issues with device functionality or availability that could impact the conduct or outcomes of this research study.

  • Any such dispute will not be resolved by a lawsuit or resort to court process, except as the federal arbitration act provides for judicial review of arbitration proceedings.

  • Accordingly, the purpose of this section is not only to determine the extent to which Foundation Phase educators employ the learners’ home language to facilitate instruction in their classrooms, but also the pedagogical approaches deployed in such instances.


More Definitions of Site Principal Investigator

Site Principal Investigator or “Site PI” means the PI for a field site, which may change from time to time. At the time of signature, the Site PIs are as follows: Xx. Xxxxxxx Xxxxx Field site PI: Kenya xxxxxx@xxxxxxx.xxx Xx. Xxxx Xxxxx Field site PI: The Gambia xxxxxx@xxx.xx Xx. Xxxxx Xxxxxxx Field site PI: Mali Xxxxxxxx@xxxxxxxx.xxxxxxxxx.xxx Dr. Xxxxxx Xxxx Field site PI: Zambia xxxxx@xx.xxx Xx. Xxxxxx Xxxxx Field site PI: South Africa XxxxxxX@xxxx.xx.xx Xx. Xxxxx (Xxx) Xxxxxxx Field site PI: Thailand xxx0@xxx.xxx Dr. Xxxx Xxxxxxx Field site PI: Bangladesh xxxxxxx@xxxxxx.xxx

Related to Site Principal Investigator

  • Principal Investigator means the Personnel who is identified as principally responsible for the performance and supervision of research associated with a Contract.

  • Private investigator means any individual who engages in the business of, or accepts employment

  • Investigator means an individual who is:

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Project Engineer means the surveyor or engineer employed by or private

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Project Team means Owner, Contractor, A/E and consultants, any separate Contractors employed by Owner, and others employed for the purpose of programming, design, and construction of the Project. The members of the Project Team will be designated in writing by Owner and may be modified from time to time in writing by Owner.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Project Leader shall have the meaning set forth in Section 3.01(e)(v).

  • Site / Work place means the lands and other spaces above & below the ground level on which the works are to be carried out, any other lands or places provided by the Owner for the purpose of the Contract.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical Trial means any human clinical trial of a Product.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Public research university means Rutgers, The State University

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

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Researcher means an individual who: