Clinical Data definition

Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

Clinical Data means information concerning safety or performance that is generated from the use of a device and is sourced from the following:

Examples of Clinical Data in a sentence

• If Data User and Data User principal investigator acknowledge and agree to the above terms and conditions for transfer of the TRACK-TBI dataset Clinical Data, Biospecimens, and/or Imaging Studies , please so indicate by returning one copy of this Agreement signed and dated by Data User principal investigator and by a duly authorized representative of Data User.

• In accordance with Participant consent, the Participating Site shall permit the Sponsor’s appointed representatives and any appropriately appointed monitor access to all relevant Clinical Data for monitoring, source data verification and adverse event reporting or investigation as appropriate.

• Principal Investigator shall promptly notify Sponsor of any withdrawal of or changes in the informed consent of a Clinical Trial Subject, which may affect the use of such Clinical Trial Subject’s Clinical Data under this Agreement.

• Subject to clause 6 below, the Participating Site agrees to treat the Results, excluding any Clinical Data of the Study, as Confidential Information of the Sponsor and the Sponsor agrees to treat Personal Data and confidential patient information as Confidential Information.

• Clinical Data Any data which relate to a specific Participant which may include, without limitation, medical records, medical imaging data, scans, questionnaires, readouts of individual biomedical or genetic analysis.

More Definitions of Clinical Data

Clinical Data means all information made, collected or otherwise generated under or in connection with clinical studies, including any clinical study reports, toxicology reports, development plans, clinical study plans, data and results with respect to any of the foregoing, or data from other human use that is submitted to Regulatory Authorities.

Clinical Data means drug monographs as well as any pertinent clinical studies, including peer review literature.

Clinical Data means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

Clinical Data means all data (including raw data) and results generated by or on behalf of either Party or at either Party’s direction, or by or on behalf of the Parties together or at their direction, in the course of each such Party’s performance of the Study; provided however, that Clinical Data does not include Sample Testing Results.

Clinical Data means personal data as defined in Directive 95/46/EC and in the Dutch privacy Law, i.e. any information relating to an identified or identifiable Clinical Trial Subject.

Clinical Data means the personal and/or patient-related information and data which may be disclosed by UHN to MBI under this Agreement and/or the Exclusive License Agreement;

Clinical Data means all data (including raw data) and results generated under the Study; excluding, however, Sample Testing Results.