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)”.

Study Report means: (a) with respect to the [*], the [*] containing [*]; and (b) with respect to the [*], the [*].

Study Report means a written report of the Study Results.

Examples of Study Report in a sentence

• The primary deliverable will be a Final Feasibility Study Report with data needed to make informed decisions for a future of resiliency supporting long-term improvements and short-term pathogen TMDL implementation.

• To do this, NCC would first submit to EPA, by June 27, 2024, an Engineering Study Report concerning the feasibility and emissions-reduction efficiency of Low-NOx Burners (“LNB”) installed on each kiln at its Fernley facility, as operated in conjunction with the existing selective non- catalytic reduction (“SNCR”) at such kilns.

• 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.

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

• The East Falls Church Bus Bay Expansion Study Report dated July, 2021, included a comparison of all alternatives.

More Definitions of Study Report

Study Report means the clinical investigation summary report based on the Study Data and drafted by the SPONSOR.

Study Report. The QF Interconnection Study Report issued by GPC in response to Generator’s QF Interconnection Request.

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 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. 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 the final study report from the Study, including, without limitation, data from patients in the reference group referenced therein.

Study Report includes a document, status information, and any other reporting tool describing the progress or outcomes of a Study or other work undertaken by Chiltern for Insmed.