Effective July 21, 2023, the Office of Clinical Research (OCR) will create ALL NEW studies in OnCore on behalf of the investigator/study team!
NEW PROCESS:
- Access the form here: Human Subjects New Study Submission Form.
- Upload the protocol. (You will still need to upload it later in InfoEd for IRB Review).
- Complete ALL questions in the form and click "Continue." You will receive a pop-up notice about the OCR process timeline. If you do not receive the pop-up, check to see if all fields were completed. Once completed, click "Continue." Contact OnCore@utmb.edu if you still do not receive the pop-up.
- OCR will create the study in OnCore and pull it into InfoEd. YOU MUST COMPLETE THE QUESTIONS IN INFOED AND UPLOAD STUDY DOCUMENTS
- The Investigator and form submitter will receive an email from OCR with the IRB #. You will need to login to InfoEd to enter your IRB # in the search field (Top, right corner of screen) in order to start the submission for IRB review.
More Details:
- The webform is interactive to provide definitions and clarifications as well as skip logic.
- The webform will not process if any questions are left unanswered.
- OCR tries to process new studies the same day of receipt, however, this is dependent on staffing and new study volume. It may be 2-3 business days before you receive your IRB #.
- If your webform is returned for completion or correction, make the corrections or completions, then click "Continue." OCR will NOT begin processing until all fields are complete and correct. Failure to re-submit the form timely will result in delayed study creation.
| STUDY ROLE | ONCORE TRAINING | ONCORE ACCESS | ONCORE TIVOLI REQUEST | INFOED TIVOLI REQUEST |
|---|
| Researchers – No subject management | NO | NO | NO | YES |
| Study Teams – No subject management | NO | NO | NO | YES |
| Researchers with subject management | YES – SUBJECT MGT ONLY [unless delegated to a study team] | YES – SUBJECT MGT [unless delegated to a study team] | YES – SUBJECT MGT ONLY [unless delegated to a study team] | YES |
| Study Teams with subject management | YES | YES | YES | YES |
Please contact OCR at OnCore@UTMB.edu for questions.
________________________________________________________________________________________________