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

• Site shall insure that the informed consent allows for the use, transfer, processing and holding of any Study Data that contains personal data to and by Sponsor, and Sponsor’s use of the Study Data, in the United States, provided, however, Sponsor shall only have access to dissociated data of Study subjects, and will not participate in the collection of the personal data of Study subjects, or have access to the files and/or documents where the Investigator or the Site keep such information.

• Institution shall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor for Sponsor’s use.

• Institution shall afford Sponsor and IQVIA and their representatives and designees direct access to Institution ’s facilities and to Medical Records, Study Data, procedures and records related to the Study (clinical and financial) so as to permit Sponsor and IQVIA and their representatives and designees to audit and monitor the Study.

• Institution shall afford regulatory authorities direct access to Institution ’s facilities and to Medical Records, Study Data, procedures and records related to the Study (clinical and financial), and any other information that may be required by the authorities, and the right to copy Medical Records (to the extent permitted by Applicable Data Protection Laws) and Study Data.

• Study Data: all data, 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, whether written, printed, graphic, video or audio format) required to be delivered to Sponsor pursuant to the Protocol and all records regarding inventories and dispositions of all Investigational Product.

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;

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 records, data and documentation including but not limited to the Case Report Forms relating to the Study.

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).