What is eTMF in pharma?

What is eTMF in pharma?

An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content.

What is eTMF in Veeva Vault?

Vault eTMF is the only software that manages documents in real-time as the TMF is generated to ensure a constant state of inspection readiness, increase visibility and oversight, and improve collaboration.

What is a trial master file in clinical research?

A Trial Master File (TMF) is a compilation of documents that prove that the clinical trial has been conducted following regulatory requirements (including Good Clinical Practice). The TMF plays a crucial role in ensuring that the trial has been managed successfully by the Investigator, Sponsor and Institution.

What is TMF software?

What is a TMF? The trial master file is like a central filing cabinet where you store all the documents, forms, and files for a clinical study. These essential documents are created throughout a clinical study by the sponsor and their staff, the CRO and their staff (if you use one), and the clinical sites.

What is the purpose of eTMF?

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.

What is an eISF?

Clinevo electronic Investigator Site File (eISF) is a cloud based, easy-to-use and highly secured electronic document management platform for investigator sites involved in the clinical trial for full control over their investigator site files (ISF).

Is veeva a CRM?

The Veeva CRM suite of products is the proven and most advanced CRM solution for the life sciences industry.

Is Veeva Vault A TMF?

Veeva Vault eTMF is the only electronic trial master file that enables an active TMF operating model.

Who keeps the trial master file?

sponsor
Article 58 requires that “the sponsor and investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial.” This requirement defines a minimum retention period across the EU for all clinical trial master files, irrespective of whether the data …

What is EDC?

To put it simply, an Electronic Data Capture (EDC) system is software that stores patient data collected in clinical trials. Sponsors, contract research organizations (CROs), and sites have adopted EDC systems to carry out both simple and complex trials in all phases of research.

What is the investigator site file?

An Investigator Site File (ISF) should be established at the beginning of each clinical trial. The ISF contains the minimum list of essential documents that have to be maintained throughout the clinical trial.

What is an electronic trial master file?

Jump to navigation Jump to search. An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.

What is a trial master file audit?

A trial master file is a collection of important documents pertaining to a study, clinical trial or other form of research. Periodically, the trial master file must undergo audits to ensure the research is being conducted in compliance with federal and local laws, regulations or funding requirements.

What is the definition of a trial master file?

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…