I-CTMS Resources for Oncology Clinical Trials

Learn more about the components of the I-CTMS:

OnCore

OnCore

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

Submit OnCore financials calendar and budget build requests: HCCC-OnCoreCalBuild@uiowa.edu

Submit OnCore-related protocol status and staff change requests: HCCC-RegDocProDevMon@healthcare.uiowa.edu.
Note: Research team members listed in the HawkIRB application should be added or removed via an IRB modification.

Note: All interventional and observational cancer-related protocols are required to register participants in OnCore for NCI reporting purposes. 

eReg

eReg

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 

Step 1
Request Access to eReg

Step 2 If applicable
EXTERNAL USERs: If you need electronic medical record (EMR) access (e.g., Epic) you will be contacted by the Data Coordination Team to complete a CareLink form, unless already on file. For questions regarding access or issues with your AFL user account please email the Data Coordination Team: CRS Data Coordinators CRSDataCoordinators@team.uiowa.edu. - (NOT REQUIRED FOR IOWA STAFF)

Step 3
An account at Advarra University created, if it did not previously exist, and coursework has been assigned.

Step 4
Upon completion of the survey, coursework, and creation of a HealthCareID account at IOWA HEALTH CARE, you will be provided your personal initial login details to eReg. For questions regarding access or issues with your EXT or IOWA user account please email the IT Team: OC eReg Request OC-eRegRequest@healthcare.uiowa.edu.

eReg Guidance Documents and Tools:

21 CFR Part 11 Compliance Documents

• UIHC FDA Letter Compliance Part 11
• UIHC Electronic Signatures Compliance Part 11
• UIHC Validation Statement Advarra eReg

EDC

EDC                                                                                   

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

 
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.

Additional links:

Note: Log in to Advarra University required

• Add Courses
• Resources
• Community Forums