Clinical Trial Management System
A Clinical Trial Management System, also known as CTMS, is a customizeable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial. It maintains and manages the planning, preparation, performance, and reporting of clinical trials, with emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones such as those for regulatory approval or the issue of progress reports. Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers.
In the early phases of clinical trials, when the number of patients and tests are small, most managers use an in-house or home-grown program to handle their data. As the amount of data grows, though, organizations increasingly look to replace their systems with more stable, feature-rich software provided by specialized vendors. Each manager has different requirements that a system must satisfy. Some popular requirements include: budgeting, patient management, compliance with government regulations, and compatibility with other data management systems.
Each sponsor has different requirements that their CTMS must satisfy; it would be impossible to create a complete list of CTMS requirements. Despite differences, several requirements are pervasive, including: project management, budgeting and financials, patient management, investigator management, EC/IRB approvals, compliance with FDA regulations, and compatibility with other systems such as data management systems, electronic data capture, and adverse event reporting systems.
- Choi B, Drozdetski S, Hackett M, Lu C, Rottenberg C, Yu L, Hunscher D, Clauw D., Usability comparison of three clinical trial management systems, AMIA Annu Symp Proc. 2005;:921.
- Payne PR, Greaves AW, Kipps TJ., CRC Clinical Trials Management System (CTMS): an integrated information management solution for collaborative clinical research, AMIA Annu Symp Proc. 2003;:967.
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