Study Sponsor definition

Study Sponsor has the meaning set forth in the preamble of this Agreement.
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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’.
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Study Sponsor. By: Name: Title: Date: TriCore: By: Name: Title: Date: 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, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ NE, Albuquerque, NM 87102 (“TriCore”) and […], (“Investigator”).
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Examples of Study Sponsor in a sentence

  • An assessment of causality will also be performed by Study Sponsor utilizing the same definitions, as shown below: 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.

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

  • For performance of the Study Sponsor will compensate the Institution for each enrolled Subject treated in accordance with the Protocol, on a pro-rata basis, see Table below.

  • 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.

  • 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.

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

  • The Investigator is required to maintain up-to-date, complete regulatory documentation as indicated by the Study Sponsor and the Investigator’s files will be reviewed as part of the ongoing study monitoring.


More Definitions of Study Sponsor

Study Sponsor means (i) with respect to an AstraZeneca Sponsored Clinical Study, AstraZeneca and (ii) with respect to a Fusion Sponsored Clinical Study, Fusion.
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