Trial Master File definition

Trial Master File means the file referred to in section 23.

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Trial Master File has the meaning set forth in Section 4.5.4.

Trial Master File means the guidelines on and the documentation relating to a Clinical Study, including archiving, qualification of inspectors, inspection readiness and inspection procedures to verify compliance of the Clinical Study in question with Directive 2001/20/EC, as amended, and dependent legislation and to enable the evaluation of the conduct of the Clinical Study and the quality of the data produced therefrom.

Examples of Trial Master File in a sentence

During the term of this Agreement, Worldwide shall maintain all materials and all other data or documents included in the Trial Master File obtained or generated by Worldwide in the course of providing the relevant Services in accordance with Worldwide’s standard operating procedures, including all computerized records and files (“Work Product”), in a secure area reasonably protected from fire, theft and destruction with duplicate copies retained with the same care as the original Work Product.
A copy of this form must also be filed in the Trial Master File (TMF).
The signed and completed Packaging Order (GCP004-B) is sent back to the CSC and filed in the Trial Master File (TMF).
If the Parties do not agree as to whether the Trial Master File is complete, the matter will be referred to the Executives for resolution.
The Executives will meet promptly and negotiate in good faith to resolve the dispute and agree upon a complete Trial Master File.

More Definitions of Trial Master File

Trial Master File means the official auditable file of study Essential Documents and Relevant Communications maintained by the Sponsor and its delegates (e.g., Contract Research Organizations (CROs) and vendors) that facilitates the conduct and management of the clinical trial and allows evaluation of the integrity of the study record and compliance with Good Clinical Practice (GCP).

Trial Master File. (TMF)” refers to a repository of documents that collectively can be used by monitors, auditors, assessors, and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol.

Trial Master File means, to the extent related to any Compound, the essential documents for the conduct of the Clinical Trial with respect to such Compound according to the ICH-E6 Guidelines for Good Clinical Practice.

Trial Master File has the meaning ascribed to such term in Section 2.8.1. 1. 1.114. “TIL(s)” means autologous human polyclonal T-cell populations derived from solid tumors and consisting primarily of human T-cells and substantially free of natural killer (NK) cells, dendritic cells (DC) and macrophages, which are not manipulated for specific neoantigen reactivity by genetic modifications or other methods.

Trial Master File means the collection of documents and data that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced and serve to demonstrate the compliance of the investigator, sponsor, and monitor with all applicable standards and regulatory requirements.

Trial Master File means a paper or electronic file that includes all of the documents that Sponsor must record and retain to demonstrate that it has met its obligations for the conduct of the Study.

Trial Master File means, with respect to a clinical trial, the official auditable file of essential documents that individually and collectively permit evaluation of the conduct of such clinical trial and the quality of the data produced in such clinical trial, and relevant communications that document agreements or significant discussion regarding the administration of such clinical trial administration, protocol violations, clinical trial conduct and adverse event reporting, in each case maintained by the Sponsor of such clinical trial and its delegates (e.g., Contract Research Organizations (CROs) and vendors) that facilitates the conduct and management of such clinical trial and allows evaluation of the integrity of the study record and compliance with Good Clinical Practice.