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Documentation configuration

The Documentation Config feature is designed to provide tools for the configuration of the files generated or uploaded for the site, staff, institutions, trip reports (including confirmation and follow-up letters), and payment requests. These configurations specify the documents' storage path in the eTMF application, file naming conventions, headers, cover pages, and much more.

In the following sections, you can learn how to maintain documentation configuration in CTMS:

In this section:

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

Group of individuals involved in making the study conduct possible. This includes various roles such as principal investigators, study coordinators, data managers, clinical research associates, and others who contribute to the planning, execution, and management of the study.

A data management, healthcare, software, or another organization that cooperates with the sponsor to provide data or services for a study.

See also: participating organization

A document that summarizes the activities, observations, and findings of a monitoring visit conducted by a clinical research associate (CRA) or a monitor at a clinical trial site. The purpose of a trip report is to provide a detailed account of the visit, including the review of study data, source documents, regulatory compliance, and overall study conduct.

An electronic version of a trial master file (TMF) is a type of content management system for a clinical trial used to organize and store files required for compliance with government regulatory authorities like the FDA, EMA, or others.

Get to know all the possibilities of the app with the comprehensive eTMF User Guide.