CTMS

Q.1 What is the workaround if sites are added in CTMS before the eTMF room is built?

Answer: To ensure those sites appear in the eTMF, follow these steps:

  1. In CTMS, update the site status from Selected to Planned.
  2. Wait a few minutes to allow the integration to process.
  3. Switch the site status back to Selected.
  4. Verify that the eTMF reflects the updated site entries.

Q.2 How does CTMS handle unblinded data? Does it offer a way to restrict certain roles from accessing unblinded subject data?

Answer: CTMS does not capture any data that could lead to the unblinding of a blinded individual. Blinded data, such as drug dosing and treatment assignments, is not collected within the system and cannot be included in visit reports. The CTMS strictly records basic subject-related metadata for identification purposes (e.g., subject ID, enrollment ID) along with details of the ICF signed by the subject and their visit dates—nothing beyond this.

Q.3 What is the CTMS offering in Trial Interactive?

Answer: Clinical Trial Management System (CTMS) is a secure, cloud-based solution that enables the collection and management of trial-related data in a single location. TI CTMS provides the ability for clinical study team members, such as study managers and CRAs to plan, collaborate, and track clinical data with specific attention to monitoring requirements. TI CTMS can help customers by providing:

  • An integrated real-time view of Clinical Trial data
  • The ability to track and view product, program, study, country, site, organization, contact, subject and subject visit data in real-time
  • The ability to plan study-related activities such as site visits, communications, training, and other key trial Milestones with due dates and responsibility
  • The ability to reduce risk by meeting regulatory compliance
  • The ability to manage trial-related documentation with a built-in Content Management System and integrated eTMF
  • The ability to improve quality through standardized business practices and record-keeping
  • Trial insights through study and portfolio dashboards

  • A streamlined eClinical processes to reduce costs

Q.4 What are some key features of CTMS?

Answer: CTMS contains various levels of Clinical Trial data, providing a centralized location to enter, review, and access this data. Users can view data from a global perspective or in the context of an individual clinical trial or program:

  • Contacts (at a global level)
  • Organizations/Sponsors (at a global level)
  • Programs
  • Products
  • Studies
  • Study Countries
  • Study Sites
  • Study Subjects
  • Site Visits
  • Site Visit related documents
  • Activities/Actions/To-Dos
  • Milestones (Study, Country, Site)
  • Study, country, or site related contacts
  • Study, country, or site related organizations
  • Study team membership

  • Enrollment statistics

Q.5 What are the key differentiators of Trial Interactive CTMS?

Answer: Key standouts within Trial Interactive CTMS are as follows.
  • Part of Trial Interactive E-Clinical Platform.
  • A configurable SAS offered CTMS, providing each customer with the ability to make their own business process modifications while still utilizing a SAS product.
  • Contains in application dashboards.
  • Provides a direct integration with Trial Interactive eTMF, reducing the need to create study-related information and allowing for use of CTMS and eTMF dashboards for customers utilizing both the TI CTMS and eTMF products.
  • Allows for unique user roles based on individual customer needs.
  • Utilizes study team membership to control data visibility.

Q.6 What is the industry background of CTMS?

Answer: The goal of a Clinical Trial Management System (CTMS) is to provide a centralized location for the study team to manage clinical trial-related data. CTMS provides the ability to maintain and manage trial-related data through the planning stage all the way through trial execution to study closure. Users have the ability to plan, prepare, track, monitor, ensure compliance, and report on collected data. CTMS provides a single source of truth helping to reduce frustration within the team and saving time.

Q.7 Which browsers are supported for Trial Interactive CTMS?

Answer: Trial Interactive CTMS is tested with all major browsers, including Chrome, Firefox, Safari, and Edge.

Q.8 Is Trial Interactive CTMS compatible with iPads or other tablets? Can it also be used on iPhones?

Answer: CTMS is built on a user interface framework designed to function across various screen sizes, including iPads, tablets, and mobile devices like Android phones and iPhones. However, each device must be thoroughly tested to ensure compatibility with its specific screen size and touch interface. Currently, the myTI product is specifically optimized for iPhones to facilitate document capture at the site by the CRA.