The I-CTMS (Iowa Clinical Trials Management System) is an enterprise-wide, software application system that supports the management of clinical trial data including protocol details, participants, data collection forms, calendars, financials, and billing. Use these resources to support your learning and engagement with the I-CTMS.
This website is intended to familiarize you with the I-CTMS and provide information and contacts to assist investigators, research team members, and others involved in oncology research.
Note: Non-Oncology I-CTMS resources are available at the Institute for Clinical and Translational Science
Learn more about the components of the I-CTMS:
OnCore is a user-friendly and comprehensive clinical trial management system (CTMS) that supports day-to-day activities including:
• Protocol administration
• Participant tracking
• Sponsor invoicing
• Comprehensive reporting
• Electronic data capture
Access and training: Request Access to OnCore
OnCore Support: OC-OnCoreAdmin@healthcare.uiowa.edu
Note: All interventional and observational cancer-related protocols are required to register participants in OnCore for NCI reporting purposes.
Advarra eRegulatory Management System (eReg) is an electronic regulatory binder maintenance system that allows organizations to store essential protocol documents, staff credentials, and organizational regulatory documents.
eReg provides a centralized location for all staff credentials and organizational regulatory tracking documents. This centralized data can be utilized across multiple protocols. eReg can also manage effective dates and ‘valid until’ dates on documents and URLs. Documents that require signature can be routed within eReg for electronic signature (in a manner that is compliant with 21 CFR Part 11). A user will receive a notification from eReg when their electronic signature is required on a document
Study staff, monitors, and auditors can access Advarra eReg via a web-based interface. Review sessions can be configured, allowing Sponsors the ability to remotely monitor regulatory binders.
Access and Training Steps
Request Access to eReg
If a signed UI Carelink form is not on file, you will also be requested to provide a signed Carelink form. Information from the Carelink form is provided to our University Identity Management team to create your personal External Account ID. - (NOT REQUIRED FOR IOWA STAFF)
An account at Advarra University & assigned coursework completed.
Upon completion of the survey and coursework, and creation of a Healthcare ID account at the University of Iowa, you will be provided your personal initial login details to eREG.
eReg Support: OC-eRegRequest@healthcare.uiowa.edu
eReg Guidance Documents and Tools:
21 CFR Part 11 Compliance Documents
Advarra Electronic Data Capture (EDC) application allows investigators to manage study data (subject calendars and forms) while maintaining 21 CFR Part 11 compliance.
Access and training: Request Access to EDC
EDC Support: HCCC-EDCRequest@healthcare.uiowa.edu
Note: All FDA-regulated interventional cancer protocols under the oversight of the HCCC DSMC are required to utilize EDC for safety and endpoint data collection.
- Access for External Monitors
All external monitors must complete a brief activation process to access OnCore and eREG:
1. Complete an Request for Access Survey
2. Provide information necessary for the creation of an external HealthcareID – this is typically done with a UIowa CareLink form
a. Users who do not need OnCore access may opt to complete a survey instead.
b. Complete CareLink forms should be returned to OC-eRegRequest@healthcare.uiowa.edu
c. Complete the course “Advarra eReg 1300: Reviewer (Internal or External Monitor) Curriculum” on Advarra University (more details below)
3. Activate account via activation link sent through email (before the 24-hour expiration)
To change your assigned temporary password: https://healthcareid.uiowa.edu
For questions regarding your OnCore/eREG access, please contact OC-eRegRequest@healthcare.uiowa.edu
- Advarra University
Advarra University training webinars are available online via this link. You can register for courses in their online store for free and review functionality that is available within the I-CTMS.
Advarra University FAQs
Q: How can I get a reminder of [eREG function/process]?
- A: If you wish to review any material covered in courses you have taken previously, you can “Relaunch” any course from the “Completed Courses” tab on your dashboard.
Q: I’ve completed my Advarra University course, but it still says it’s not complete. Why?
- A: To complete an Advarra University Course to 100%, be sure to click through the “Module Complete” page at the end of each module.
Q: I completed my Advarra University course, and nothing happened. Why?
- A: Our eREG access team periodically checks course completion throughout the day. To expedite/obtain a reason for the delay, please forward your completion certificate to OC-eRegRequest@healthcare.uiowa.edu.
Note: Log in to Advarra University required