Submit a study through the OCR Study Activation Portal

Use the OCR Study Activation Portal to submit studies that meet the criteria for entry into the OnCore Clinical Research Management System. The portal collects the information OCR needs to begin applicable activation activities.

Note: Studies managed by the IU Simon Comprehensive Cancer Center Clinical Trials Office should follow the Cancer Center pathway in the Cancer Center trials section below.

Questions may be directed to the OCR Financial Compliance team at ocrfin@iu.edu.

Start your portal submission

Use the OCR Study Activation Portal to submit new studies, amendments, and other OCR-supported submissions.
You may save your progress and return later. Submit only when required information and documents are ready.

Review these resources before submitting a study through the OCR Study Activation Portal:

• Revised Clinical Study Activation Process – A Quick Start Study Guide
• Are You Ready to Submit? A Checklist and OCR Portal Resource Guide
• OCR Activation Alignment – FAQ

Gather key items before starting

Before starting, gather the protocol, draft consent form, IU IRB number, and applicable budget, agreement, IPID or Proposal Development Document number, manuals, service details, billing information, and study team contacts.

Answer research billing questions carefully.

Answer billing questions carefully. Your responses help determine whether coverage analysis, billing review, or other Financial Compliance support is needed.

What happens after submission?

After submission, OCR and participating review groups begin applicable activation activities. Study teams may be asked to provide clarifications, join a kickoff meeting, or complete assigned OnCore task list items.

Where to get help

Review the resources above first. Questions may be directed to the OCR Financial Compliance Team at ocrfin@iu.edu.

If your study involves cancer research or cancer patients, the OnCore build pathway depends on the managing research department. All cancer-related studies and studies involving cancer patients that meet PRMS guideline criteria must complete Scientific Review through the Cancer Center process. More information is available on the Cancer Center Scientific Review Committee (SRC) for Oncology page.

• If your study involves cancer research or cancer patients and will be managed by your department, not the Cancer Center Clinical Trials Office, follow the OCR submission steps above.
  • After your protocol shell has been built in OnCore, follow OCR’s email instructions to submit the protocol to the Cancer Center Scientific Review Committee through the ePRMS Console in OnCore. More information is available on the Cancer Center Clinical Trials Office page.
• If your study will be managed by the Cancer Center’s Clinical Trials Office (CTO), first submit directly via the ePRMS console in OnCore as described in the Cancer Center SRC instructions and then you must complete an abbreviated submission form via OCR’s Study Activation Poral as outlined above."

The OCR Study Activation Portal is one part of study activation. Review additional requirements in the Clinical Research Roadmap.