Study Initiation definition

Study Initiation means with respect to a Clinical Trial, [***].
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Study Initiation means the enrollment of the first patient in a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial.
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Study Initiation means the first visit of the first patient enrolled in a given clinical study during which the Therapeutic Product is administered in accordance with the protocol.
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Examples of Study Initiation in a sentence

  • Sponsor reserves the right to immediately terminate this Agreement and to exclude Hospital and Investigator from further participation in the Clinical Study, if within three (3) months after the Study Initiation Visit no patients are participating in the Clinical Study.

  • SOP # 3 Title: Study Initiation Procedures ProceduresThis SOP outlines the procedure for preparing for study initiation.

  • Sponsors have the option of ordering a 4% study to be submitted in the 9% round, with the advantage that if 9% tax credits are not awarded, the same study could then be submitted for 4% credits instead.To order a study through MSHDA, applicants need to submit a Market Study Initiation Request with details of their proposal to MSHDA for a market study to be ordered.

  • The payment schedule and price of this study are as follows: · 15% Due upon Authorization* · 12.5% Due upon Study Initiation (Day 1) · 12.5% Due Interim – Month 2 · 12.5% Due Interim – Month 3 · 12.5% Due Interim – Month 4 · 12.5% Due Interim – Month 5 · 12.5% Due Interim – Month 6 · 5% Due upon Submission of Draft Report · 5% Due upon Submission of Final Report** *Invoice(s) will be sent no more than 60 days prior to scheduled study start.

  • Institution and Investigator agree that, if at any time from the beginning of the Study (Study Initiation Visit), until one (1) year from the end of the Study (Study Close-out Visit), Institution and/or Investigator should become aware of any changes in the financial disclosure any Subinvestigator participating in the Study, Institution and/or Investigator will immediately notify MedImmune and cooperate with MedImmune in providing a revised financial disclosure statement reflecting all required changes.

  • If Study Initiation of the Phase III Clinical Trial in the Oncology Field referenced in Section 7.1 does not occur by December 31, 2011, then (i) Licensee shall pay Symphony a non-refundable fee equal to *** less any amounts actually paid by Licensee to Symphony pursuant to Section 4.2.1 and Section 4.2.2 and (ii) Symphony shall have the right to terminate this Agreement with respect to the Oncology Field, effective immediately.

  • They should be used as a starting point to ensure compliance.Appendix D: RSIF and EPIC Build‌RSH Record Build and Maintenance:Research Study Initiation Request Form (RSIRF)• PI shows interest in participating in a study.• Forwards request to Admin.

  • Task 1 – Study Initiation PurposeThis task will prepare the ARBS MOA and POS.

  • Bluebird will provide written notice to Celgene of the enrollment of the first patient in each initial Clinical Study for each Product Candidate (the “Clinical Study Initiation Notice”).

  • An examination of the case studies provides some guidance on the application of traffic demand analysis in MISs. This section summarizes this information in three ways: (1) guidance concerning the steps in the MIS process, (2) lessons learned from each case study, and (3) guidance on the application of traffic demand analysis tools in MISs. GUIDANCE CONCERNING THE MIS PROCESS Study Initiation • The development of a detailed work plan is always important to the management of any planning study.

Related to Study Initiation

  • 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 Trial means any human clinical trial of a Product.

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

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

  • 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.

  • Initiation means, with respect to a Clinical Trial, the administration of the first dose to a patient in such Clinical Trial.

  • 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;

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.