Study Sponsor definition

Study Sponsor. By: Name: Title: Date: TriCore: By: Name: Title: Date: SAMPLE Appendix A Statement of Work # […] This Statement of Work under the Master Clinical Study Agreement (the “SOW”) between Study Sponsor _____________ (“Study Sponsor”) and TriCore Reference Laboratories (“TriCore”), dated […] (the “Agreement”) is entered into and effective on this […] day of […], 20__ (the “Effective Date”) by and between Study Sponsor, (“Study Sponsor”); TriCore Reference Laboratories, 0000 Xxxxxxxx Xxxxx NE, Albuquerque, NM 87102 (“TriCore”) and […], (“Investigator”).
Sample 1
Study Sponsor means a person, company, institution, group, or organization that oversees a clinical trial and collects and analyzes the data. ‘Study Sponsor’ may also be called ‘trial sponsor’.
Sample 1
Study Sponsor has the meaning set forth in the preamble of this Agreement. 1.26 „Zadavatel klinického hodnocení“ má význam stanovený v úvodních ustanoveních této Smlouvy.
Sample 1

Examples of Study Sponsor in a sentence

  • The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of seriousness and/or causality.

  • The Investigator should provide the Study Sponsor with any new safety information (which includes new AEs and changes to previously reported AEs) that may affect the safety evaluation of the device.

  • The Study Sponsor will notify the Investigator of any AEs that are upgraded from non-serious to serious or from unrelated to related.

  • An assessment of causality will also be performed by Study Sponsor utilizing the same definitions, as shown below: Causality Related An AE classified as related may be either definitely related or possibly related where a direct cause and effect relationship with the medical device or study procedure has not been demonstrated, but there is a reasonable possibility that the AE was caused by the medical device or study procedure.

  • Site monitors are appointed by the Study Sponsor and are independent of study site staff.

  • Agreements made by the Study Sponsor with the Investigator/Institution and any other parties involved in the clinical study will be provided in writing as part of the protocol or as a separate agreement.

  • The site may not screen subjects or perform the informed consent process on any subject until it receives a notification from an appropriate Study Sponsor representative that the site may commence conducting study activities.

  • Further, depending upon the nature of the AE or device deficiency being reported, the Study Sponsor may request copies of applicable portions of the subject’s medical records.

  • The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved.

  • If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor representative prior to unmasking the information if there is sufficient time.


More Definitions of Study Sponsor

Study Sponsor has the meaning set forth in the preamble of this Agreement. 1.25“Zadávateľ štúdie“ význam uvedený v preambule tejto zmluvy.
Sample 1
Study Sponsor means (i) with respect to an AstraZeneca Sponsored Clinical Study, AstraZeneca and (ii) with respect to a Fusion Sponsored Clinical Study, Fusion.
Sample 1

Related to Study Sponsor

  • Project Sponsor means an eligible governmental agency receiving program funds pursuant to an approved application.

  • Non-Lead Sponsor means the Note A-2 Holder in its capacity as the sponsor with respect to the Non-Lead Securitization Note in connection with the Non-Lead Securitization.

  • Sponsor shall have the meaning given in the Recitals hereto.

  • 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.

  • Investigator means an individual who is:

  • Prototype Sponsor Means the entity specified on the Adoption Agreement which sponsors this prototype plan.

  • 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.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Collaborator An individual who is not under the direct supervision of the PI (e.g., not a member of the PI’s laboratory) who assists with the PI’s research project involving controlled-access data subject to the NIH GDS Policy. Internal collaborators are employees of the Requester and work at the same location/campus as the PI. External collaborators are not employees of the Requester and/or do not work at the same location as the PI, and consequently must be independently approved to access controlled-access data subject to the NIH GDS Policy.

  • 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).

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Independent study means a subject/program/activity that a person pursues autonomously that meets standards for approval criteria in the rules and includes a posttest.

  • Faculty Member means any person hired by the college or District to conduct classroom or teaching activities or who is otherwise considered by the college to be a member of faculty.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Study Subject an individual who participates in the Study, either as a recipient of the Investigational Product (defined below) or as a control. Subjekt studie: jednotlivec, který se účastní Studie, buď jakožto příjemce Hodnoceného léčiva (ve smyslu níže uvedené definice) nebo jako kontrolní subjekt.

  • CRO means a contract research organization.

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

  • Study Data shall have the meaning set forth in Section 8.1.

  • independent review committee means the independent review committee of the investment fund established under National Instrument 81-107 Independent Review Committee for Investment Funds;

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

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

  • 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).

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.