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In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Tracing in software engineering refers to the process of capturing and recording information about the execution of a software program. This information is typically used by programmers for debugging purposes, and additionally, depending on the type and detail of information contained in a trace log, by experienced system administrators or technical-support personnel and by software monitoring ...
The terminated merchant files are shared among processors and act as blacklists, where merchants with high-risk accounts or excessive chargebacks are put on the list and prevented from opening an account with a different credit card processor. Other reasons for being put on a terminated merchant file include: Merchant collusion; Fraud; Money ...
An audit trail (also called audit log) is a security-relevant chronological record, set of records, and/or destination and source of records that provide documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device.
For computer log management, the Common Log Format, [1] also known as the NCSA Common log format, [2] (after NCSA HTTPd) is a standardized text file format used by web servers when generating server log files. [3] Because the format is standardized, the files can be readily analyzed by a variety of web analysis programs, for example Webalizer ...
In software development, a traceability matrix (TM) [1]: 244 is a document, usually in the form of a table, used to assist in determining the completeness of a relationship by correlating any two baselined documents using a many-to-many relationship comparison.