Clinical
eTMF Software Systems
An electronic trial master file (eTMF) is a trial master file that is in digital format and contains the essential data from a clinical trial that is subject to regulatory oversight.
Not only must a TMF contain accurate and compliant documentation, it must also be organized appropriately for evaluation by inspectors and sharing among study team members. MasterControl goes beyond basic document management by enabling real-time visibility into clinical study activities with an eTMF software system based on the TMF Reference Model.
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The Value of an eTMF System
Managing thousands of clinical documents, tasks and processes using paper-based or hybrid TMF systems can be overwhelming and may introduce errors or result in oversights that jeopardize your clinical trial’s compliance. MasterControl eTMF software solutions offer an industry best-practice approach to document management that empowers you with the insights needed to efficiently manage your clinical trials and accelerate products’ time to market. MasterControl’s eTMF systems effectively manage clinical processes and seamlessly integrate them with other compliance-critical quality processes.
TMF Management Challenges |
MasterControl eTMF Solution |
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Document Management Headaches Managing the high volume and granularity of all the documents that make up a clinical trial master file is problematic. |
Efficient Document Management MasterControl’s eTMF JumpStart configuration is based on the industry-recognized TMF Reference Model. This standard format facilitates completeness and consistency and provides a blueprint for a successful TMF plan. |
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Audit Inept When trial master file documents are scattered among different systems and paper files, it takes more time and effort to prepare for audits and inspections. |
Audit Ready MasterControl TMF software ensures your eTMF is automatically kept up to date and that it can provide a single source of truth on a continual basis. |
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Disorganized Content It’s difficult to organize TMF documentation in a consistent format and central location that allows information to be properly placed and conveniently accessed. |
Precisely Organized The built-in MasterControl Taxonomy Explorers create folder structures based on metadata that is populated within each document. These electronic TMF tools simplify the organization of the TMF by automating the placement and creation of TMF folders. |
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Laborious Batch Transfers Transferring high-volume batches of information and content back and forth between various sources (i.e., sponsors, clinical sites, internal teams, etc.) is overly complicated and often impractical. |
Streamlined Transfers MasterControl provides multiple methods for easily importing and exporting batches of content into and out of the eTMF system. The smooth exchange of information simplifies interactions between teams and with partners like sponsors and contract research organizations (CROs). |
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Document-Sharing Difficulties Sharing critical study and site-related documentation with sites and third parties like sponsors and CROs is essential but cumbersome for everybody involved. |
Seamless Sharing MasterControl eTMF software solutions include predefined configurations that give access rights to sponsors, CROs and study sites. Documents and collections of documents can be shared easily among authorized internal and external groups. |
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Inefficient Document Exchange The exchange of documents between partners (i.e., sponsors and CROs) and sites is risky and error-prone without a secure, controlled environment. |
Expedient Exchange MasterControl’s Guest Connect feature allows users to invite external parties to upload content into the eTMF system in a controlled manner using placeholders that can be released by the document manager upon verification. |
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Chaotic Collaboration Collaborating on, editing, reviewing and approving documents with internal and external groups is cumbersome when everyone uses different systems. |
Optimal Collaboration With MasterControl’s eTMF systems, internal system users and external parties can be invited into a virtual collaboration space where they can collaborate on trial master file documents. |
Moving Away from Paper to Software Systems
The inherent difficulties of using paper-based document management systems to handle literal tons of TMF documentation are increasingly leading organizations to switch to more effective eTMF software solutions. Electronic TMF management allows for a superior, efficient approach to document management and increases visibility into clinical trials. A reliable eTMF software system is an invaluable process management tool that integrates TMF-related activities with other compliance-critical quality functions.
- Complete Study ManagementMasterControl electronically connects all the numerous documents, tasks and processes involved in clinical studies that are dependent on each other and share common information.
- Specialized Design Our eTMF software systems have been developed by MasterControl experts under the direction of a member of the Drug Information Association’s (DIA) TMF Special Interest Area Community (SIAC).
- Holistic Paradigm The integrated modules of MasterControl’s eTMF software solutions facilitate the reuse and sharing of information and maximize efficiency throughout every clinical trial process.
- Clinical Quality Management MasterControl’s TMF system is a complete clinical quality management solution designed to improve oversight, enhance transparency, effectively manage risk and strengthen compliance at every stage of a clinical trial.
- Standardized FrameworkRooted in the TMF Reference Model’s eTMF template for organizing metadata and document types, MasterControl eTMF software ensures that consistency and compliance will always be promoted.
- Cloud AdvantagesMasterControl’s eTMF software runs on a single cloud-based platform that provides a uniform configuration and substantial flexibility and cost benefits. It also greatly simplifies validation and upgrade processes.
- Configurable Document TypesDocument types in MasterControl eTMF systems can be configured to include only the applicable document templates — such as a protocol template — for users to select from when they create new documents.
- Enhanced ProductivityAll users of the eTMF system can substitute their time-consuming manual tasks with more efficient and traceable electronic processes.
- Optimal AccessibilityMasterControl’s secure web-based eTMF systems are accessible to all authorized study teams and partners from any geographic location, at any time and from any device.
- Expedited SearchElectronic TMF data can be located and retrieved quickly with MasterControl eTMF software’s dynamic search capabilities.
eTMF Template
The first step of developing a TMF plan is visualizing the eTMF’s fundamental parameters. To help guide you along the eTMF template development path, you can download the complimentary MasterControl TMF Checklist Template.
This free eTMF template is an Excel spreadsheet developed by a member of the DIA TMF Working Group that can be used as a blueprint for your own eTMF file structure. Based on version 3 of the globally recognized DIA TMF Reference Model, the eTMF template was created to help organizations streamline the collection and organization of their trial master file documentation from study initiation to study closeout. It’s a helpful aid for clinical organizations that are working toward implementing an eTMF solution or those that want to supplement their existing paper-based TMF systems.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
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To learn more about MasterControl's software systems, please contact a MasterControl representative.
