A trial master file (TMF) contains essential documents and artifacts associated with a clinical trial which are subject to compliance with ICH GCP, FDA 21 CFR Part 11 and other regulatory requirements. The TMF must not only contain adequate and accurate data, but it must also be organized in a manner suitable for evaluation by inspectors, and sharing with clinical study team members both internally and externally.
Managing thousands of clinical documents, tasks and processes using a paper-based or hybrid TMF system can be overwhelming and can introduce errors and oversights that put your clinical trial at risk for noncompliance. An eTMF software must provide an industry best practice approach to document management which allows you to gain the insight you need to efficiently manage your clinical trials and accelerate your time to market.
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).
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.