Clinical Data definition

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 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 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.

Examples of Clinical Data in a sentence

• Electronic submission of the site level dataset is voluntary and is intended to facilitate the timely selection of appropriate clinical sites for FDA inspection as part of the application and/or supplement review process.This request also provides instructions for where OSI requested items should be placed within an eCTD submission (Attachment 1, Technical Instructions: Submitting Bioresearch Monitoring (BIMO) Clinical Data in eCTD Format).

• This study will be monitored by the Clinical Data Update System (CDUS).

• This study will be monitored by the Clinical Data Update System (CDUS) version 3.0. Cumulative CDUS data will be submitted quarterly by electronic means.

• Neither Party shall be liable for any use that the other Party may make of the Clinical Data nor for advice or information given in connection therewith.

• This study will be monitored by the Clinical Data Update System (CDUS) version 3.0. Cumulative CDUS data will be submitted quarterly to CTEP by electronic means.

More Definitions of Clinical Data

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

Clinical Data means any and all data (together with all Clinical Trial reports and the results of analyses thereof) derived or generated from any Clinical Trial of a Compound or Product or from testing of subjects or the analysis of samples used in any such Clinical Trial.

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 the original human subject data and case report forms (CRFs) collected or generated with respect to Clinical Studies of any Licensed Antibody or Licensed Product, together with all analysis, reports, and results with respect thereto.

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.