About Clinical Trials Management System (CTMS)

The Clinical Trials Management System (CTMS) is part of a Mayo Clinic research strategic initiative to standardize the processes, tools, and systems that support clinical research. CTMS reduces redundant systems and processes, thereby shortening the entire clinical trial lifecycle, and increases the capacity to conduct other types of clinical research.

In the current phase of CTMS, the key deliverable is organization-wide implementation of Medidata Rave, an industry-leading electronic data capture (EDC) and data management system.

Benefits

Implementing CTMS/Rave will enhance Mayo Clinic's competitiveness in obtaining government and industry funding for clinical research, reduce duplicative systems, increase data quality and reduce overall costs related to managing clinical trials and conducting clinical research.

Some of the key benefits include:

For Investigators

• Reduced administrative burden and increased capacity for research
• Integration with other institutional tools such as IRBe and MIRIS
• Increased competitive advantage with respect to government and industry funding
• Greater efficiency of data collection, validation and analysis

For Industry Sponsors and Collaborators

• Expanded capability to manage large and complex clinical research studies, including multi-site clinical trials
• Synergy with Mayo's well-developed clinical laboratory services and clinical research program, making Mayo an ideal coordinating site for drug and device trials and other large clinical research studies

CTMS Components

• Data Management — As the core function of CTMS, Medidata Rave provides a comprehensive and integrated electronic data capture (EDC) system. Rave offers superior flexibility and reliability in data collection, storage, retrieval, validation, analysis and reporting for complex and multi-site studies.

  For less complex studies, Mayo Clinic offers investigators two additional institutionally supported data management tools: REDCap CRF/REDCap Survey or SDMS (Requires that you be logged in to the Mayo network).

• Research Participant Tracking — Future plans for CTMS include integrating the research participant tracking module with the Mayo Clinic electronic medical records so patients' records are automatically flagged to alert physicians that their patient is enrolled in a clinical trial.