Site Principal Investigator definition

Site Principal Investigator means The individual taking responsibility for the conduct of the Study at the Clinical Centre
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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.
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Site Principal Investigator means the Site Principal Investigator is the investigator at a Member who will lead the Study at that Institution.
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Examples of Site Principal Investigator in a sentence

  • Definition of Austin Health Site Principal Investigator (only required if different from Co-ordinating Investigator)Austin Health Site Principal Investigator, a person who is suitably qualified, willing and able to take responsibility and have oversight of the project at Austin Health.

  • Site Principal Investigator Study Role Email Declaration Date Endorsements Page Department Representative Endorsement The Department Representative can be the Head/ Chief/ Research Head of the PI’s Department.

  • 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.

  • In my formal capacity as a Site Principal Investigator, my duties include ensuring the safety of the study participants enrolled under my supervision and providing the Jaeb Center for Health Research, which serves as the Coordinating Center for the protocol, with complete and timely information, as outlined in the protocol.

  • 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.

  • 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.

  • It is the responsibility of the Site Principal Investigator to ensure that a current record of investigational product disposition is maintained at each study site where investigational product is inventoried and disposed.

  • In my formal capacity as a Site Principal Investigator, my duties include ensuring the safety of the study participants enrolled under my supervision.

  • 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: Principal Investigator Role Contact Information 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
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Related to Site Principal Investigator

  • Principal Investigator or “PI” is the person, designated by University, and accepted by Sponsor, who is directly responsible for executing, directing, overseeing and reporting a Sponsored Project under this Agreement.

  • 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;

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Quality Surveillance Engineer / Inspector means any person appointed by or on behalf of the Purchaser to inspect or carry out quality surveillance on supplies, stores or work under the Contract or any person deputed by the Quality Surveillance Engineer for the said purpose.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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).

  • 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 clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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.

  • 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 a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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 a person appointed by us to carry out research into theoperation of this Contract;

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.