MasterControl Documents™, a web-based document management software system, automates and effectively manages documents to help ensure compliance with FDA 21 CFR Part 11 regulations and other regulatory requirements. The MasterControl TMF Reference Model™ JumpStart configuration is an easy to use system that allows you to create, edit, manage, approve and share documents required for each trial and easily monitor the documents throughout the entire lifecycle of a clinical trial.
MasterControl TMF Reference Model™ JumpStart provides an out of the box configuration of the MasterControl Documents module based on the DIA TMF Reference Model to include predefined InfoCard (document)types, taxonomy organizers, routes (workflows), collaboration, electronic signatures, roles, version control, vaults (access control models), lifecycles, and PDF rendering, to name a few. This configuration is designed for the management of electronic trial master file clinical study documents for pharmaceutical, biotech and medical device products requiring clinical studies. The MasterControl TMF Reference Model JumpStart provides a standardized organization of critical documentation while providing default access rights based on document types to both internal and external partners such as sponsors, clinical research organizations (CROs) and clinical site personal (i.e., principle investigators).
Automated TMF Organizers Based on Custom Fields
TMF Management Challenges
MasterControl TMF Solution
|Difficulty managing the high volume and granularity of all documents that make up a clinical trial master file.||The MasterControl TMF Reference Model JumpStart® configuration is based on the DIA Reference Model. Using this model will increase efficiency and provides a central location for all required TMF documents.|
|Organizing TMF documentation in a consistent structure to facilitate placement and location of information.||MasterControl Taxonomy Organizers are designed to create folder structures based on metadata populated within each document to automate the placement and creation of electronic TMF organizers.|
|Transferring high volume batches of information and content to and from various sources (i.e., internal, CROs, sponsors, clinical sites).||MasterControl provides various methods for batch importing and exporting of content to and from the clinical management system to facilitate the relationship between sponsors and CROs.|
|Sharing of critical study and site-related documentation with partners (i.e., sponsors and CROs) and sites as needed.||MasterControl TMF includes predefined rights access configuration for sponsors, CROs and sites. Documents, as well as collections of documents, can be easily shared with internal and external partners.|
|Exchanging documents between partners (i.e., sponsors and CROs) and sites in a controlled environment.||MasterControl GuestConnect® feature of Documents allows a user to invite external parties to upload content into the system in a controlled method using a placeholder which must then be released by documentation manager upon verification.|
|Collaborating on, editing, reviewing and approving documents with both internal and external partners.||The MasterControl GuestConnect® feature of Documents allows a user to invite system users as well as external parties to controlled “collaboration spaces,” enabling them to work collaboratively on documents.|
Features and Benefits of MasterControl eTMF Software
- Designed by Experts: MasterControl TMF JumpStart is a configuration that has been developed by MasterControl with the guidance of a member of the DIA SIAC. This configuration of document types and metadata based on the DIA TMF Reference Model was designed to promote a common configuration across the industry for clinical trial document management.
- Simple Implementation: Using the MasterControl TMF JumpStart decreases implementation time and ensures that companies get a more standard configuration.
- Mobile Access: External light users and mobile users can quickly access information in the clinical management software system that is critical to their roles (monitor, auditor, investigators) as well as enhance the flow of information and execution of tasks, thereby reducing cycle time (i.e., review, approval and training).
For More Information on MasterControl's Clinical Management Software Systems
For more information about our clinical management software systems and jumpstart options, please feel free to contact a MasterControl representative.