Only one form can be in process on a study at any given time (excluding Reportable New Information forms).
To Start a Study
Log in to CLARA and click “Create a New Submission” on the upper left. Then select “New Study” in the popup window.
To Request a Human Subject Research Determination
If you are unsure whether your project requires IRB review, you can ask for a determination from the IRB. Log in to CLARA and click “Create a New Submission” on the upper left. Then select “Human Subject Research Determination Request” in the popup window.
Submit the corresponding form in CLARA. The titles of most forms are self-explanatory. Some new forms/uses of forms are:
- Reportable New Information: Use to report study events to the IRB. Study events include adverse events, deviations, and notifications. See Reporting to the IRB for more information on how to use this form.
In order for your study to be placed on a meeting agenda for Full Board Review, materials must be submitted by 4:30 p.m. Monday, two weeks prior to the meeting date.
See Meeting Calendar for more information.