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Introduction to CTMS

The Clinical Trial Management System (CTMS) is a part of the eClinical platform that provides end-to-end solutions for the maintenance of diverse study aspects. The main features and capabilities of the CTMS application are as follows:

  • Process management: you can perform clinical data analysis via charts and tables representing CRF completion, subject phase dynamics, study data validation, enrollment status, and query completion statistics throughout your study.

  • Quality management: you can perform clinical data quality control via the charting system organized by study, site, or subject to guarantee detailed and precise information analysis.

  • Staff management: you can maintain and organize the work processes of your study by managing sites, institutions, and staff details via the unified CTMS tool.

  • Budget management: you can maintain budget settings for your project, create and manage payment requests, and track financial statistics by reviewing payment reports and details.

  • Risk management: you can maintain study data validation and monitoring processes, as well as track and avert protocol deviations.

With CTMS, you can maintain a library of templates, workflows, codelists, and reference data. Also, you can create different entities like sites, staff accounts, budget plans, payment requests, and more. These are manageable to reflect the individual needs of every study and create a flexible system for your business.

Sources of CTMS study data

The Clinical Trial Management System (CTMS) is a part of the eClinical platform that provides end-to-end solutions for the maintenance of diverse study aspects. The data acquired by the CTMS application comes from different sources within the eClinical ecosystem, as follows:

Sources of CTMS study data
Figure 1. Sources of CTMS study data

  • ADMIN: CTMS works with studies that have been configured via the ADMIN application.

  • EDC: CTMS displays real-time data pulled from the EDC application on the Study Insights dashboard and study-specific charts (Clinical Study, Clinical Sites, and Subjects).

  • Internal CTMS library: CTMS provides an option to create sites, workflows, protocol deviation templates, and more to satisfy the needs of your study.

In this section:

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.