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 prevent unauthorized access to the Study Data by maintaining physical security of the electronic system and ensuring that Study Staff maintain the confidentiality of their passwords.

• Investigator agrees to collect all Study Data in Medical Records prior to entering it into the CRF.

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

• In case of termination of Investigator employment relationship, the responsibility for maintaining Medical Records and Study Data shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Data.

More Definitions of Study Data

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

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

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 means: (a) the actual raw results, records and data of the Combined Therapy Clinical Trials, including the case report forms (CRFs) for such study and all raw data as recorded in such CRFs; (b) all information relating to adverse events resulting from the Combined Therapy Clinical Trials, including all reports of Adverse Events, Serious Adverse Events, and Serious Adverse Drug Reactions; (c) all analyses of the raw results of the Combined Therapy Clinical Trials conducted using the statistical analysis plan and any bioanalysis plan pursuant to or set forth in the applicable Protocol (or as otherwise agreed to by the Parties); and (d) the Final Study Report, the periodic reports (e.g. quarterly), and all other reports of the results of the Combined Therapy Clinical Trials or the analyses of such results prepared under this Agreement in accordance with the applicable Protocol prior to the completion of the Final Study Report.