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)”.
Study Report means a written report of the Study Results.
Study Report means: (a) with respect to the [*], the [*] containing [*]; and (b) with respect to the [*], the [*].
Examples of Study Report in a sentence
An internationally recognized environmental management consulting firm shall be engaged by ETG or its Subsidiaries to produce an Environmental Impact Assessment Study Report concerning the development of the Project, which shall be updated as the development proceeds.
More Definitions of Study Report
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;
Study Report. The QF Interconnection Study Report issued by GPC in response to Generator’s QF Interconnection Request.
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.
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.
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.
Study Report means the clinical investigation summary report based on the Study Data and drafted by the SPONSOR.
Study Report means the final study report from the Study, including, without limitation, data from patients in the reference group referenced therein.