What a Clinical Trial Management System (CTMS) is…
As the name suggests, a CTMS is a software solution for managing clinical trials. The system helps you organize all aspects of a clinical trial: staff, roles, timelines, resources, procedures, finances, and participants – all in one place.
A CTMS can be used in a way that makes sense for your team. That might be to stay organized with a single study or to consolidate the management of multiple studies and sites.
What a CTMS is not…
Unlike an electronic data capture system, patient data is not collected directly into a CTMS (but you can use it to keep track of the links to your study’s EDC).
A CTMS helps ensure regulatory compliance but it is not a replacement for a regulatory binder. Having said this, OnCore offers an optional eReg module that may be added at a later stage
If you’re wondering who selected the CTMS, the short answer is that we all did. A cross-section of Alberta based clinical trial staff, investigators, and business representatives got together to evaluate vendors and CTMS products in an RFP process led by the NACTRC.
The NACTRC, the University of Alberta, and Alberta Health Services (Tom Baker Cancer Centre and Cross Cancer Institute) unanimously selected the OnCore Clinical Trial Management System from Advarra (previously known as Forte Research).
The participating institutions are:
The Cross Cancer Institute
University of Alberta
University of Calgary
We are all implementing OnCore in 2021.
We gratefully acknowledge Alberta Innovates, Jobs Economy & Innovation, and the Alberta SPOR SUPPORT Unit for their investment in this provincial initiative.
Custom interfaces allow for information to be automatically transferred between OnCore and other systems. We’re working with the participating institutions to develop these interfaces. Right now, this includes single sign on (so you can use your regular username and password to log into OnCore) and ethics (so you don’t have to copy information back and forth from IRISS and ARISE).
Other integrations include PeopleSoft and Connect Care – these opportunities are still being explored.
Benefits of a CTMS by Role:
This is a single place for the whole team to track participants, visits, and studies.
Price-out studies, build budgets, generate invoices, reconcile payments, and run financial reports.
Streamline operations, define workflows, assign staff, track study progress, and demonstrate investigator oversight.
Get a full print out of expected study visits and procedures.
Generate reports at a study, research group, department, or institutional level.
Document visits and findings directly in the audit and monitoring console.
Benefits by Study Activity:
Use the charge master and draft budgets to price out studies for sponsor budget negotiations.
Use task lists to track submissions, assign staff to study tasks, use the protocol calendar to anticipate staff and resource needs, link your protocols to ethics applications.
Enrol participants on study, set up study specific schedules of events, project participants’ visit dates and track their progress, assign upcoming tasks to study personnel and track completion, easily see what needs to happen next.
Create institutionally customized invoices based on study milestones and visits/procedures completed, then reconcile received payments. Use the vendor payables module to track payments that you owe to others.
Document modifications and associated approvals. Use ‘reconsent required’ to identify which participants need to be reconsented.
Need a quick overview of your accruals? Want to know your research group’s trial revenues? Being asked for a status report? Use OnCore Insights to generate custom reports.
Have more questions? Want to get involved?
Your perspectives are important, and we need them to make sure that our implementation of OnCore meets your needs. If you have questions, concerns, or some words of encouragement for your Implementation Team, we’d love to hear from you.
Let us know where you work, what role you perform, and how we can support you with OnCore.