Study Report definition

Study Report means the clinical trial summary report based on the Study Data and drafted by the Sponsor which should be notified to the competent authorities in accordance with section 4.3 of the Communication of the Commission nr. 2010/C 82/01, entitled “Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)”.
Sample 1Sample 2Sample 3
Study Report means: (a) with respect to the [*], the [*] containing [*]; and (b) with respect to the [*], the [*].
Sample 1Sample 2Sample 3
Study Report means a written report of the Study Results.
Sample 1Sample 2

Examples of Study Report in a sentence

  • Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within twelve (12) months of Clinical Trial completion, Xxxxxxx or its designee may post the results of the Clinical Trial to a clinical trial results web site in the form of a Clinical Study Report Synopsis in ICH-E-3 format, if applicable.

  • Unless earlier terminated in accordance with the provisions of this Agreement, this Agreement shall continue until complete performance of the Study, i.e. when the last enrolled Study Participant has finished the treatment described in the Protocol all CRFs and any other pertinent Study-related documents have been received by and completed to the reasonable satisfaction of the SPONSOR, and the Study Report has been drafted by SPONSOR.

  • Cluster Study Report shall mean the report issued following completion of a Cluster Study pursuant to Section 42.4 of the LGIP.

  • After the issuance of the Surplus Interconnection Service System Impact Study Report, PacifiCorp tendered a draft Surplus Large Generator Interconnection Agreement, including the Energy Displacement Agreement as an appendix, to Xxxxxxxxx XXXX III LLC.

  • Parties agree that the sent & receipt of the Study Report is the confirmation of the complete performance of the Study.


More Definitions of Study Report

Study Report. The QF Interconnection Study Report issued by GPC in response to Generator’s QF Interconnection Request.
Sample 1Sample 2
Study Report means a report generated by the CTSN DCC for the purpose of providing the unblinded trial results to the NHLBI-appointed Data Safety and Monitoring Board (DSMB) and the CTSN investigators, the latter of whom may publish the trial results once the trial is completed. The Study Report will contain the complete data analysis set, including unblinded safety and efficacy outcomes, and, where not self-explanatory, an explanation of the applicable analyzed data set.
Sample 1Sample 2
Study Report means a written report that contains information required by ICH guidelines after the Clinical Trial in question is closed but before database lock for such Clinical Trial.
Sample 1Sample 2
Study Report means the clinical investigation summary report based on the Study Data and drafted by the SPONSOR.
Sample 1Sample 2
Study Report means the clinical study summary report based on the Study Data (as defined in Article 1.14) and drafted by the SPONSOR which shall be notified to the ethics committee and/or if applicable the competent authorities in accordance with Applicable Laws;
Sample 1
Study Report. The final written study report after completion of the Protocol which contains the clinical and statistical description, presentations and analyses of the Results.
Sample 1
Study Report has the meaning set out in Section 5.3(d).
Sample 1