Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.
Study Completion has the meaning set forth in Section 3.11.
Study Completion shall occur upon database lock of the Study results.
Examples of Study Completion in a sentence
The Study Completion Date is used to ascertain timing for study results posting and reporting.
The Study Completion Date is defined as the date the final subject, across all sites, completes their final protocol-defined assessment.
In the ordinary course of events this Agreement terminates on Study Completion.
If the Study is a Multi-centre Study, then the Institution agrees that no Publication of the Study results may be made until Publication of the results of the Multi-centre Study or 2 years after Study Completion, whichever is the sooner.
Again, Karla will be contacting and assisting study teams as their Primary Completion Date or Study Completion Date approaches.
More Definitions of Study Completion
Study Completion means the last Subject visit specified in the Protocol for primary endpoint evaluation.
Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the CRG, including a copy of the letter from the Responsible EC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.
Study Completion means database lock of the Study results.
Study Completion means [***], as applicable.
Study Completion means the point at which the database for the Study has been locked and all Essential Documents have been provided to the Sponsor and/or upon receipt by the Sponsor of the closure letter from the Principal Investigator. Study Materials means data, results, information, Case Report Forms (or their equivalent) generated in the course of conducting the Study. For the avoidance of doubt, Study Materials do not include the Institution’s ordinary patient records including the medical records of the Study Participants.
Study Completion for each Study shall occur upon final database lock of such Study with respect to the Study Field. Within four (4) months following Study Completion of a given Study in the Study Field, Sponsor shall provide Regeneron with a preliminary draft of the final clinical study report and the tables and listings for such Study (“Study Results”), in electronic form. If Regeneron undertakes to submit comments to the draft clinical study report they shall be provided within thirty (30) days following Regeneron’s receipt of the draft clinical study report. Sponsor shall consider in good faith any comments made by Regeneron to such report, and shall not include any statements pertaining to the Regeneron Product (or its use in the Combination) that have not been approved by Regeneron, provided that any objection by Regeneron shall be made in good faith. If Regeneron does not provide comments with respect to any such matter within the applicable period identified above, Regeneron’s approval shall be deemed to have been provided. Sponsor shall provide Regeneron with the final version of the clinical study report within a reasonable time following Sponsor’s receipt of Regeneron’s comments, but in no event later than the date that is three (3) months after such receipt (or, if Regeneron does not provide comments, after the expiration of the thirty (30) day period following Regeneron’s receipt of the draft clinical study report). If Regeneron does not provide comments with respect to any such matter within the applicable period identified above, Regeneron’s approval shall be deemed to have been provided.
Study Completion shall be deemed to occur upon lock of the Study database. Ideaya shall ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive or any other similar Applicable Law in connection with the Study permit such sharing of Clinical Data with Pfizer.