CTMS gives organizations the ability to track and manage their clinical trial operations. CTMS is part of the Vault Clinical Operations family of applications. Within a single Vault, your organization can have one, two, or all of these applications. These applications share a common data model, but each provides additional pieces of functionality to help manage the clinical trial process.
CTMS Vaults provide the following capabilities:
- Study Manager Homepage: Provides a single page for Study Managers to view key information, status, metrics, and data at the Study, Study Country, and Study Site levels.
- Study Management: Provides the ability to track and manage events, milestones, metrics, performance, and compliance across a study.
- Issue Management: Provides the ability to capture, track, and manage observations, risk mitigation actions, protocol deviations, and follow up items for a study.
- CRA Homepage: Provides a single page for CRAs to view key information, including status, enrollment metrics, deviations, and monitoring visits at the Study, Study Country, and Study Site levels.
- Site Monitoring: Provides the ability to manage all aspects of routine monitoring visits (Pre-Study Visit, Site Initiation Visit, Interim Monitoring Visits, and Close Out Visit), including confirmation and follow up letters, monitoring visit reports, and tracking of on-site monitoring activities.
- Study Communication: Provides the ability to manage study personnel and their contact information, and to track all communication regarding the study.
- CDMS & Clinical Operations Vault Connection: Allows for the exchange of Studies, Study Countries, and Sites from Clinical Operations CTMS Vaults to CDMS EDC Vaults, and the exchange of Subjects, Subject Visits, Procedures, and Visit Definitions from EDC Vaults to CTMS Vaults.
- Subject Visits: Provides the ability for study managers to define visits for a Study, create and track visits and related source data verification (SDV) activities for a given Subject, and use this data in monitoring reports and other study management reports.
- Vault Payments: Provides the ability for study managers to manage payment requests, expenses, and budgets related to a trial.
- Clinical Trial Notifications: Provides the ability to generate and submit Yuzu Clinical Trial Notifications (CTN) to the Japanese Health Authority (PDMA).
- Risk Based Study Management (RBSM): Provides the ability for study teams to create, review, and approve study-specific risk assessments.
CTMS shares common data model components with eTMF and Study Startup Vaults, which allows organizations to consolidate their data for all Clinical Operations applications in one Vault. In addition, there are a set of CTMS-specific objects and a set of supporting objects. The supporting objects contain data that is mostly static or automatically populated. Typically, users will not create records for supporting objects.
In addition to the shared data model, the CTMS application has additional objects to house data. This is a list of core CTMS objects, but it does not include all objects.
- Visit Definition: This object defines the types of visits a subject within CTMS can be a part of during the course of this trial. Visit Definitions are used in Subject Visits which occur over the course of a clinical trial and can include screening visits, monthly visits, end of trial visits, and more.
- Study Arm: This object tracks Study Arms that are available for a Study. Admins can associate a Subject to a Study Arm defined for the Study.
- ICF (Informed Consent Form) Tracking: The Informed Consent Tracking object tracks the master “Informed Consent Form” for a given trial including its Version and Version Date. Vault uses this object in tandem with the Informed Consent Site Effective Tracking object to track a clinical site’s IRB or EC approval of the “Master Informed Consent”.
- Central Monitoring Event: This object tracks oversight Monitoring Events where the study team wants to track issues and outcomes across multiple study sites.
- Activity: This object tracks interactions with persons. Activities can be logged within or outside the context of a clinical study.
- Metrics: This object contains the planned, forecast, and actual enrollment and performance metrics for the study, study countries, and sites. Vault automatically creates or updates records in this object after a subject is added, a subject’s status changes, or there are changes to a Study, Study Country, or Study Site record.
- Subjects: This object contains a list of all subjects in the study, their current enrollment statuses, and applicable status dates. This object is typically populated via integration or regular file load from a data capture or randomization system.
- Site SAE Tracking: This object captures information about “Serious Adverse Events” that occur related to Subjects for this particular Site.
- Issue (
pdv__ctms): This object captures information about issues that occur related to Subjects, Study Sites, and for the study as a whole.
- ICF (Informed Consent Form) Site Effective Tracking: The Informed Consent Site Effective Tracking object tracks a Site’s IRB or EC approval of the trial’s “Master Informed Consent.”
Monitoring Event-Related Objects
- Monitoring Event: This object represents a monitoring event. These could be on-site visits, telephone contacts, or remote monitoring activity. Study personnel can use this alongside the associated objects (Monitoring Visit Participants, Monitoring Activities, Monitored Subjects, Monitored Informed Consent Forms, Monitoring Event Follow Up Items, Monitored Subject Visits) to manage the planning, conduct, and follow-up for all monitoring events. The Monitoring Event object is also the central location to use trip reports.
- Monitored Subjects: This object contains a snapshot of the subjects at a site and their status at the time of the monitoring event. In the event that a monitor finds a subject status to be incorrect during a monitoring visit, the monitor can add or edit the subjects for the monitoring event.
- Monitored Subject Visits: This object contains a snapshot of the Subject Visits at a site and their relevant data that has either been source-data verified or need to be source data verified.
- Monitored ICF (Informed Consent Form): The Monitored Informed Consent Form object contains information about when a Subject signed the “Site Effective Informed Consent” and what version of the “Master Informed Consent” was signed.
- Monitored Follow-Up Items: The Monitored Closed Follow Up Items and Monitored Closed Follow Up Items objects contain Follow Up Items that are either currently open or have been closed since the last Monitoring Event.
- Monitored Issues: This object contains Issues that are related to a Monitoring Event.
- Monitored Metrics: This object contains a snapshot of the actual enrollment by this site in the trial at the time of the Monitoring Event.
- Monitoring Activity: This object contains the list of activities expected to be completed throughout the course of the Monitoring Event.
- Monitoring Visit Participants: This object contains the list of site participants that are expected to participate in the trial along with information about whether they were invited or attended the Monitoring Event.
- Trip Report Question Responses: This object contains questions and answers to the questions that should be asked of the site or while performing a Monitoring Event.
There are other objects that make up the CTMS data model. These are all available for use and configuration within your Vault. In order to accurately maintain the real-world relationships between these data elements, the data model includes several many-to-many and parent-child relationships linking objects together.
Key Shared Objects
This list provides some explanation of core objects in the data model but is not a complete list of shared objects for Clinical Operations (eTMF, Study Startup, and CTMS) Vaults.
- Study Person: This object assigns a person and their appropriate contact information to a study or study site and role, allowing organizations to manage both Vault users and non-Vault users in a single list.
- Study Organization: This object allows users to assign specific roles to an organization at the Study, Study Country, or Study Site level.
- Study Communication: This object contains all inbound and outbound site communication and other pertinent communications regarding the study. The associated Response object tracks related follow-up communication regarding the same inquiry and the Study Communication Follow Up Item object can track, manage, and escalate required actions from the communication.
- Milestone: This object defines, tracks, and manages all pertinent study, study country, and study site milestones. Milestones can also manage the expected, planned, and actual monitoring visit start and end dates.
- Clinical User Task: This object is attached to several functions unique to Clinical applications, such as task templates and CTMS Homepages.
CTMS includes scheduled jobs that reduce manual reentry of data, and calculate the metrics required to power the Study Manager and CRA Homepages.
- Enrollment Status: This job runs nightly and snapshot the metrics and milestone data required to generate the enrollment status graph on the Study Manager and CRA Homepages.
- Monitoring Compliance Summary: This job runs nightly and calculates the number of expected and overdue monitoring events as well as the percentage of monitoring visit reports that were finalized within the expected timeframe.
Automated Object Record Creation
CTMS includes automated processes that create object records at certain intervals.
- Updated Metrics: This job calculates the actual enrollment rate, screen failure rate, dropout rate, and total number of subjects in each of the statuses. The job calculates these metrics at the site, aggregate study country, and aggregate study levels. The Updated Metrics job triggers at the site level and runs one (1) hour after a subject’s status changes. The jobs includes any changes made within the hour. Vault executes the Study Country version of this job after a site-level change within the country and the Study version executes following a Study Country change.
- Seed Monitoring Enrollment: This job runs when the Monitoring Event record is set to In Progress. This data job seeds the Monitored Subjects record with a copy of the current Subjects and their statuses for the site, as well as a copy of the current Subject Visits that apply to the Subjects created in the Monitored Subject. This reduces data entry for the CRA.
- Updated Monitored Metrics: This job provides the same functionality as the Updated Metrics jobs, but applied to the Subject data within a specific Monitoring Event.
Learn about using the CTMS application in these articles:
- CRA Homepage
- Study Manager Homepage
- Working with Trip Reports
- Issue Management
- Defining Subject Visits
- Subject & Enrollment Metrics
- Subject Recruitment Planning
- Risk Based Study Management
- Clinical Operations to CDMS Vault Connection
- Vault Payments
- Study Budget Tracking with Vault Payments
- Yuzu Clinical Trial Notifications
Learn about configuring the CTMS application in these articles:
- Trip Report Administration
- Issue Management Administration
- Configuring for Subject Visits
- Managing Subject & Enrollment Metrics
- Managing Subject & Enrollment Metrics Jobs
- Configuring Risk Based Study Management
- Configuring Vault Payments for Site Payments
- Setting Up Studies for Vault Payments
- Configuring for Study Budget Tracking with Vault Payments
- Configuring the Clinical Operations to CDMS Vault Connection
- Configuring Yuzu Clinical Trial Notifications