The study into the effectiveness and safety of modern drugs is carried out using clinical research: drugs are tested on volunteers or patients. As a result of this work, a huge amount of data is collected - from information about the patient’s health to documents related to the organization of the study, the activities of study centers, etc.
During a clinical trial, a large number of documents accumulate. For convenient access to them, and effective work with clinical trial data, special tools are needed. For this purpose, the electronic Trial Master File (eTMF) has been developed and is currently utilized.
eTMF is an electronic system that is designed to store and organize all clinical research documents. Any documents can be stored here: data on research centers, doctors’ resumes, CRFs, documents of compliance with requirements from regulatory authorities, etc. The tool has user-friendly functionality for downloading data and convenient work with documents throughout the project.
Using of eTMF is critical to modern clinical research
Initially, the use of eTMF electronic instruments was initiated by government agencies involved in the regulation of clinical trials. Specifically, these are the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA (News - Alert)). The main goal was to facilitate the systematization and management of documents in clinical trials, and this helped to make work with documents more transparent and efficient, and also simplified the regulatory review procedures.
Today, most modern studies use this tool for trial master file management. eTMF systems help team members on a project quickly and conveniently find the right documents if needed, as well as view them and manage data.
Moreover, such systems have security and confidentiality systems within them, in comparison to physical methods of data storage. Let's take a closer look at some of the most significant functions of eTMF systems.
The most important features of eTMF
Functions of quick access and search for necessary documents
eTMF systems have user-friendly functionality for downloading documents and organizing them. These products contain customizable filters, tags, and categories. This helps to create understandable groups of documents, and they can be marked according to origin and content. Thus, convenient “catalogs” of documents are formed inside the eTMF. They also allow users to access the desired document in just a few clicks. The search time for the necessary data is significantly reduced in comparison to the processing of paper copies of project documents.
Notification system
eTMF programs have automatic notification features that simplify the work of participants. So, the system can swiftly send notifications about various events within the system: the appearance of new documents, changes to existing ones, notifications for required actions, etc. This will help employees quickly respond to changes and always be aware of what is happening in the system.
Access control and visit tracking
This is one of the most important features of eTMF, and it allows you to maintain the confidentiality and safety of clinical research documents.
Each person who has access to eTMF has their own separate account with clearly defined rights and document access. That is, each person has access only to those capabilities and data that correspond to his or her functional role.
In addition, the system monitors all user actions. If necessary, the data can be reviewed, and you can find out who accessed the document, as well as when and what they did to it.
Opportunities for integration with other clinical research systems
eTMF systems play a significant role in the entire clinical research process. Therefore, it is most effective to use them in integration with other electronic systems in the project. So, in modern research, eTMF is successfully used in integration with EDC (Electronic Data Capture) systems, CTMS (Clinical Trial Management System), and others. This approach helps create a unified environment for working on a clinical trial. In such an environment, work on a project becomes more efficient, since you can quickly access any data you need without switching between different programs.
eTMF is one of the most important tools for working in modern clinical research. Thanks to its functionality, it is now possible to establish effective work in project documents. This increases the effectiveness of the test as a whole and makes it better and more transparent for various inspections and audits.
Author: Vasiliy Vinnikov, System Validation Manager at OnlineCRF by Pharmaxi LLC
