STEPS TO STUDY ACTIVATION
Complete the Office of Clinical Research Protocol Submission Form (REDCap Form 1)
Studies that meet the criteria for entry into the OnCore Clinical Research Management System and are not managed by the IUSCCC Clinical Trials Office,* should be submitted to the Office of Clinical Research (OCR) through the Office of Clinical Research Protocol Submission Form. This REDCap Survey is sometimes referred to as “Form 1.”
When your submission is complete, the OCR Research Systems team will create the study record in OnCore and build the protocol calendar if applicable. Then, when necessary, the OCR Financial Compliance team will complete the Coverage Analysis and Research Billing review. The OCR must complete all applicable reviews and provide OCR Signoff or Account Signoff in OnCore before the study may Open to Accrual.
*NOTE: For studies managed by the Cancer Center Clinical Trials Office, please see the IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information Section below.
For questions, contact the Office of Clinical Research Financial Compliance team at ocrfin@iu.edu.
Submission Process
A direct link to the OCR Protocol Submission Form is located here and on the Coverage Analysis page on the OCR website.
The OCR Submission Form collects key study documents and information about the protocol and study team. The study initiation should happen simultaneously with IRB submission and contract negotiation, with each process informing the others. Do not wait until your contracting and IRB approval processes are complete. Submission may be completed in one or two parts depending upon the documents available at time of submission.
Form 1
The submission forms can be completed by any member of the study team.
Submission Requirements (as applicable):
- Study Information, which will be entered directly into the REDCap form and used to create the OnCore study record.
- Final Approved Protocol
- Draft Informed Consent document, if available or applicable
- Draft CTA/Budget/NOA, if available or applicable
Form 2
Required documents not available at Form 1, must be provided through Form 2 before the OCR Financial Compliance Team can begin their Coverage Analysis and Research Billing review. If any of the required documents listed are not submitted with Form 1, the form submitter will be prompted by email to submit Form 2. If all the required documents are included with Form 1, no follow-up prompt will be provided.
If you have not submitted a study through the IU Office of Clinical Research Protocol Submission Form before, you should enroll in the OCR New Study Initiation Process Training course. This is a 25-minute video that covers:
- How to submit a New Study or a Study Amendment to the OCR entry process
- Information about the OCR’s Coverage Analysis Process
- Overview of the Study Submission Timeline and OnCore Workflow Status
The submission form can be completed in multiple sessions and progress can be saved along the way. When your submission is complete, be sure to download the PDF version of the completed form for your records.
Gather these documents where applicable:
- Final approved protocol (Required to submit Form 1)
- Initial/draft CTA or Sub-Award
- Initial/draft budget
- Initial/draft of ICF
- Study Specific Manuals (investigator brochure, pharmacy manual, imaging manual, etc.)
- FDA/CMS Documentation/Communications
Other questions to consider prior to completing the submission process.
- Will the study utilize Investigational Drug Services (IDS)?
- Does the study involve investigational device?
- Where will the study be conducted?
- What is the enrollment goal?
- Will you utilize Advarra Participant Payments, eRegulatory or eConsent systems?
- What is the estimated duration of the study?
- How will labs be ordered and processed?
If your study involves cancer research or cancer patients, it is important to note that new studies undergo a slightly different pathway to be built out into the OnCore Platform, depending on the managing research department. However, please note that regardless of the research department, all cancer related studies and/or studies involving cancer patients that meet the definition as outlined in the PRMS guidelines, must undergo Scientific Review via the Cancer Center’s process. More information can be found here: Cancer Center Scientific Review Committee (SRC) for Oncology.
- If your study involves cancer research or cancer patients, but will be managed by your department and not the Cancer Center’s Clinical Trials Office (CTO), please follow the steps outlined above to submit to OCR.
- Once your protocol shell has been built in OnCore, please follow the instructions from OCR via email on how to submit this protocol to the Cancer Center’s Scientific Review Committee via the ePRMS Console in OnCore. More information on the SRC process can be found on the Cancer Center’s Clinical Trials Office page.
- If your study will be managed by the Cancer Center’s Clinical Trials Office (CTO), then please do not submit protocol via OCR’s website outlined above and instead submit directly via the ePRMS console in OnCore as outlined here.
- If your study involves cancer research or cancer patients, but will be managed by your department and not the Cancer Center’s Clinical Trials Office (CTO), please follow the steps outlined above to submit to OCR.
The OCR protocol submission form is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.