A clinical trial, also known as an interventional study, is a process that aims to determine the safety and effectiveness of medical interventions including medications, procedures, and tools in living people. It involves collecting data in a systematic way of every age, health status, gender, cultural background, occupation, and race to participate. Depending on the objectives of the clinical trial, the author’s findings can help physicians make informed medical decisions by weighing the risks and benefits of the medication for their patients. Clinical trials are usually conducted by multinational pharmaceutical companies and usually take place in multiple phases, ranging from Phase I (involving a small number of healthy volunteers in a shorter period) to Phase IV (involving long-term monitoring of participants after participation). However, what constitutes an established clinical trial with the utmost integrity?
eTMF Systems Are Software and Server Application To Manage The Entire Stages Of A Clinical Trial
eTMF stands for ‘electronic Trial Master File’. It’s a system used by many established clinical trials around the world to guide, store, and track lengthy documents and data related to the trial.
eTMF is important because it ensures that every record associated with your trial is secure, easily accessible, trackable, and most importantly, compliant which is essential for good clinical practice (GCP) recognized as a requirement by regulatory agencies such as the FDA.
As the clinical trial programs expand and progress further, a real-time transparency system that can quickly identify which documents are missing and/or a product that has expired can help the research team to quickly fill those gaps and move on.
eTMF Systems Are Crucial in Ensuring That Every Record Is Secured So That It Can Be Accessed, Modified, And Verified by Relevant Parties At Any Time.
eTMF is a secure database that enables all parties involved in the trial to access, modify and verify all documents, records, and reports. It is used to store information on sponsor trials from registration through to closure.
eTMF systems can be installed by hosting providers or created in-house by organizations depending on their needs, including blockchain technology. Some of the features include:
- One central database for all data related to an eTMF system
- Password protection so no unauthorized users can access it
- Auditing capabilities that allow you to keep track of who has accessed your data at any given time
Records Are Stored Electronically in A Secure Network That Can Only Be Accessed by Individuals with Permission
Your data is stored electronically in a secure network that can only be accessed by individuals with permission. This prevents tampering and ensures that your information is accurate. This is important because clinical trials are often lengthy, time-sensitive processes.
In other words, an eTMF system allows you to complete the following tasks:
- Store all of your important and sensitive documents for those who are permitted for access only (e.g., clinical study protocols)
- Securely share these documents between your team members so they can work on them without having to worry about losing their work if someone else has already edited/modified the document in question
- Ensure that every record associated with each patient’s participation in a clinical trial is secured
There Are Several Points in The Clinical Trial Process That Require the Collection Of Documents, The Recording Of Data, And Their Subsequent Verification
Typically, an eTMF is used by multinational pharmaceutical companies and CROs, including Vial, who provide their support to the life sciences industry in the form of research services outsourced on a contract basis. The collection of essential documents includes:
- Clinical Trial Master File (CTMF)
- Protocols and Procedures Manuals
- Investigator Brochures
- Monitoring Plan Reports
- Data Validation Reports
- Audit Reports
- Participant Informed Consent Forms
- Laboratory Test Results
- Scanned Images of Documentation
- Electronic Case Report Forms and more!
The eTMF can be accessed from any computer connected to the internet by authorized users. This allows for prompt retrieval of information to facilitate decisions at all stages of the clinical trial process including submission planning, regulatory submissions, operational management, budgeting, costs savings analysis, statistical analysis, risk assessment, patient recruitment, data collection, real-time study activities, and reporting of findings.
The purpose of an eTMF is to simplify all aspects of clinical trial documentation management. Doing so helps to reduce the time spent on finding and validating documentation, reducing overall drug development costs, and increasing the efficiency of trials.
An eTMF can Be Agile and Enables Site Monitoring Too
An eTMF also enables site monitoring so that changes are recorded during a trial if anything happens – such as an adverse event or change in the protocol after approval – which requires further analysis.
The eTMF Ensures That Every Record and Collectible Data Stays Consistent
The eTMF can help your organization with three primary functions:
- Data Capture (data entering) – The eTMF serves as a single source for entering electronic records into one central database. These records include things like patient information, demographics, medical history, and treatments received. With an eTMF in place, you don’t have to worry about data being entered multiple times or getting lost due to multiple sources of information.
- Document Management (document tracking) – The eTMF allows you to track all documents within a study such as invoices, orders, or receipts related to study activities (e.g., site changes). This ensures that nothing falls through the cracks and there is no chance that important information gets lost or misplaced between departments or people involved with running studies at different sites around the world!
- Document Archiving (archived content) – The eTMF should have a robust solution to archiving huge content of the clinical trial master file for at least 25 years in a way that is readily available and accessible upon request. As the number of historical plus active clinical trials grows within an organization, this can be costly to maintain the data for decades to come. Therefore, access to archived eTMFs needs to be tested regularly.
eTMF has helped to make clinical trials more efficient and secure by making it easier for everyone involved in a trial to access and verify records. It also helps to eliminate errors, because everything is stored electronically rather than on paper.
By ensuring the integrity of the clinical trial conducted by multiple stakeholders, this ultimately improves the quality of life for patients who are waiting for new medicines!