Study Data definition

Study Data shall have the meaning set forth in Section 8.1.

Study Data means all data, databases, documents, reports and other information resulting from, collected or developed in the performance of the Study;

Study Data means the information and measurements outlined in the Study Protocol.

Examples of Study Data in a sentence

• This provision does not prohibit publication or presentation of Study Data in accordance with this section.

• Site shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records and Study Data.

• Site shall afford regulatory authorities reasonable access to Site’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data.

• The Institution and the Investigator will assign to Sponsor all of their rights, title and interest, including intellectual property rights, to all Confidential Information (as defined below) and any other Study Data.

• Institution shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records and Study Data.

More Definitions of Study Data

Study Data means, with respect to a particular Study, all data (including raw data) and results (including Study Results) generated in the performance of the Study Plan for such Study and including results obtained from testing or analysis of biological samples as part of a Study pursuant to the Protocol, if applicable, and any relevant monotherapy data generated in the course of the Study pertaining to the Sponsor Product within the Study Field.

Study Data means all data, databases, documents, reports and other information resulting from, collected or developed in the performance of the Study; “Investigational product” designates the investigational product named [INSERT STUDY DRUG/DEVICE NAME], subject of the Study and described in the Protocol; {This is not applicable if there is no product involved, eg. a particular technique or treatment is being investigated}

Study Data means all data (including raw data), Case Report Forms, findings, conclusions and other results, in all cases, from the single agent arm and Combination arm of the Study and the Final Study Report, including investigator reports (both preliminary and final), statistical analyses and expert opinions and reports. Study Data excludes Sample Data.

Study Data means all records and reports, other than Medical Records, collected or created pursuant to or prepared in connection with the Study including, without limitation, reports (e.g., CRFs, data summaries, interim reports and the final report) required to be delivered to Sponsor pursuant to the Protocol and all records regarding inventories and dispositions of all Investigational Product. .

Study Data has the meaning set forth in Section 3.4 hereof.

Study Data means all analyzed data, results and other data generated by any party or anyone under that party’s control in the course of performing a clinical trial or other research study in connection with a Clinical Study and includes patient records and CRFs. Study Data excludes Production Data as defined in Section 5.4(c).

Study Data means all data (including raw data), Case Report Forms, findings, conclusions and other results from the Study, including the Final Study Report. Study Data excludes the Sample Data. Study Data includes investigator reports (both preliminary and final), statistical analyses and expert opinions and reports.