Product Information

MasterControl Reference Model - TMF JumpStartTM

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Data Sheet 1 Data Sheet MasterControl Reference Model - TMF JumpStart™ The management of clinical trials is one of the most critical, complex, and resource consuming areas of research and development for life sciences organizations. In order to facilitate the management of the thousands of clinical documents generated throughout a clinical trial, MasterControl has developed the MasterControl Reference Model - TMF JumpStartTM best practices configuration. The MasterControl Reference Model - TMF JumpStartTM configuration is based on the Drug Information Association (DIA) Trial Master File (TMF) Reference Model (RM), which originated as an initiative through the Document and Records Management SIAC of the Drug Information Association (DIA), a globally recognized and highly respected professional association. This model consists of standardized taxonomy and metadata and it clearly defines and outlines the organization of TMF content using standard nomenclature. How Can MasterControl Help Your Organization? The MasterControl Reference Model - TMF JumpStartTM is designed for the management of TMF clinical study documents for pharmaceutical, biotech, and medical device products requiring clinical studies. The MasterControl Reference Model - TMF JumpStartTM also includes out-of-the-box configuration of taxonomy organizers, routes (workflows), roles, vaults (specifically access control models, i.e., draft, approved, etc.), lifecycles, and numbering. Further vaults, lifecycles, routes, roles, and taxonomy can be added to the configuration if and when desired. The MasterControl Reference Model - TMF JumpStartTM is designed to be used as a standalone document management configuration or in conjunction with • MasterControl eTMF Manager • MasterControl Study Manager • MasterControl Clinical Quality Management System (CQMS)

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