Creating a Follow-On Submission after Study Approval

All submissions associated with a study after the initial creation are called “follow-on” submissions. These include submission types: Modification/Update, Continuing Review, Site, and Reportable New Information.

To submit this type of information...	Start here...	Notes
Modifications to an active study Continuing review updates for an active study Request to close study	From the Active tab, click the study name (see Accessing a Submission). In the Study workspace, click this button:	You can submit a continuing review and a modification at the same time. The first form prompts you to identify the type of information to submit. To request study closure, submit a Continuing Review. Based on the research milestones completed, the study may be closed. To modify an External IRB project, see the Updating External IRB Review section in Requesting External IRB Review.
Modification or update to an active site	From the Sites tab, click the site name (see Accessing a Submission). In the Site workspace, click this button:	You can submit a modification request which is specific to sites. To provide a status update or request site closure, complete the Report Continuing Review Data activity in the site workspace and indicate the request to close in the text of the activity.
New Information or an adverse event report	For Information about a particular study, start from the Active tab, click the study name (see Accessing a Submission) For information affecting multiple studies start in one o the studies and add studies within the form. Click this button:	Report new information as soon as you become aware of it. The form identifies the types of information you must report.

Suite Outage Scheduled for November 20th, 2025 - Release (impacting OAIR, ESTR-IRB, Agreements-DUA, and Data Safety)

October 06, 2025

The research administration and compliance suite of applications, including OAIR, ESTR-IRB, Agreements-DUA, and Data Safety, will be unavailable from Thursday, November 20th, at 7:00 pm ET until Friday, November 21st, at 7:00 am ET to complete software...

Research Administration and Compliance Suite Office Hours (ESTR-IRB, Agreements-DUA, Data Safety, OAIR)

The system support team is available during regular office hours to provide one-on-one time to demonstrate system functions, provide training, answer questions, and collect feedback. Sessions cover the entire suite (ESTR-IRB, Agreements-DUA, Data Safety, and OAIR) and are customized based on the registrant preference.

Office hours are open:
• Tuesdays: 10:00am ET - 11:00am ET
• Thursdays: 3:00pm ET - 4:00pm ET

Please schedule time with us!
1. Visit the Bookings page (linked here)
2. Choose a time. Available times (not already booked) will display for 30-minute increments.
3. Share your name and email
4. Click "Book" at the bottom of the page.

After completing the steps through Bookings, you will receive a confirmation email/calendar invitation reserving the time.
If you have any questions or concerns, please contact us at estrhelp@harvard.edu.