What is Electronic Trial Master File (eTMF)?

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Electronic trial master file (eTMF) is an electronic mode of collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed.

Management of essential trial documentation is undoubtedly one of the most time consuming and costly activities associated with conducting a clinical trial.

A Trial Master file should present a historical look at the actions that have been taken over the course of a clinical trial.

A well-kept TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the trial during the audit or inspection process.

Most paper-based industries and processes have matured and benefited from some kind of digital transformation. A variety of document management software has made workplace processes far more efficient. Legal, healthcare, IT, Financial industries along with numerous other industries have all leveraged software technologies to impact the efficiency and effectiveness of their processes.

The pharmaceutical and biotech industry is no different.

Need for the digitisation of TMF

Until recently, before Information Technology (IT) became prominent in the research and medical field, managing Clinical trial regulatory documents had been paper-based. The size and complexity of a TMF were in direct proportion to the length and complexity of the trial. Paper-based processes were laborious, costly, and prone to errors.

Providing a digital platform and strategy around the capture, management, and reporting of regulatory documents was necessary to enable clinical trial stakeholders to be more productive, effective, and reduce business risk. Also, the format of a TMF, the content names and requirements varied from sponsor to sponsor, creating a high degree of variability and inconsistency.

Electronic Trial Master File (eTMF)

An industry-wide momentum to streamline clinical trial processes and adopt applications to improve operational efficiency resulted in adopting digital processes to create and manage TMFs.

A way of capturing, managing, sharing, and storing those essential documents and content from a clinical trial in a digital format is called an electronic master file or eTMF. In simple terms, it is a Trial Master File in electronic or digital format.

It is a specialized content management system used to manage clinical documents across the life cycle of a clinical trial. An eTMF system automates manual paper-based Trial Master File processes.

The International Conference on Harmonization (ICH) has defined a set of guidelines on Good Clinical Practice (GCP) and each TMF should adhere to the guidelines defined by ICH.

Any eTMF service providing the company should stick to ICH guidelines. Though the format may be different they have to essentially focus on these key items in an e TMF:

  • Digital content archiving
  • Security and Access controls
  • Change controls
  • Audit trails and System validation. 

Benefits of eTMF

  • Ease of access, approve, share and manage clinical documents anytime from a web-based application
  • Traceability, faster document searching, and retrieval
  • Access and manage the same repository of information.
  • Ability to reduce the paper use associated with each trial.
  • Improves efficiency during the conduct of a trial
  • Audit-ready reports which are far quicker than paper systems
  • Cost-savings in document management

Leading eTMF software’s

These are Industry’s top leading eTMF software’s.

Future scope of eTMF

Pharma and biotechnology companies are investing a lot in digitization. With gaining acceptance of eTMF in clinical trials, increased funding, and a rise in R&D programs by pharma companies, the worldwide eTMF market is expected to show exponential growth over the next decade.

The high growth of electronic trial master file (eTMF) can be attributed to the growing number of clinical trials across the globe and government regulations keeping eTMF mandatory for clinical trials.

eTMF will soon seize from being just a repository to store and manage files. Companies are using Cloud-based models, Artificial Intelligence (AI), Machine Learning, and other high-quality data and document management systems to generate extensive reports.

The future aim is to achieve real-time inspection and analysis of data, audit readiness, and on the fly report generation.

Thank you for reading.

Article By : Shahenaz Karadesai.

Read article on Electronic Case Report Form.

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