IRB Electronic Submission, Tracking & Reporting (ESTR) system is now live
As of November 15, 2012 all submissions including initial and continuing reviews, modification requests, Not Human Subjects requests, RNIs, etc., will go through ESTR. The basic information (e.g. protocol number, PI, IRB approval expiration date) for all existing protocols will be migrated to the new system. Investigators will be required to upload the electronic documents, such as protocol, consent form, etc. at the time of their next submission, e.g. continuing review.
Please click the following url to log into ESTR: http://irb.harvard.edu. You will need to provide your HUID and password to log into the system. If you have forgotten your HUID PIN/Password, please click here to reset it or request a new PIN. If you do not have an HUID, one can be requested for you by an HSPH Sponsor (i.e. HSPH affiliate/primary contact or Principal Investigator) by completing the Special Identity/Card Request: Non-People Soft Affiliates Form. Please click here for additional information.
ESTR Lab Training Sessions
The ESTR Help Desk will be offering lab training sessions which will cover a brief overview of ESTR & the submission process from start to finish, highlighting some of our Frequently Asked Questions:
- Uploading Study Documents (When, where, and which supporting documents need to be uploaded, and clarification of update versus delete)
- Funding Source (Review process for searching for funding and adding new funding including adding supporting grant documentation, when appropriate)
- NHSR and Exemptions (What to attach and how to manage the revised clarification process through ESTR modification)
- Submitting to IRB (Who must/can submit (when coordinators hit submit where does it go?), submission process during IRB clarification Request – when are changes actually submitted to IRB)
- Modifications (Review process for Modifications, Mod/CR, and Personnel Modification)
- Adding Study Personnel (understanding process for when Personnel form is required vs. when personnel should be adding through ESTR).
Click here to register for the lab training sessions. Seats are limited to 10 per session. Additional sessions will be added as need arises.
QIP (ESTR) Submission Assistance
Submission support, but specific to navigating ESTR. Contact a member of the QIP team to schedule an appointment for you or your study team: Stanley Estime at 617-432-2164, Alyssa Speier at 617-432-2140, or Leslie Howes at 617-432-2153 or complete the QIP Online Service Request form and one of the QIP team members will be in touch within 24 hours to schedule an appointment.
Reference Guides for IRB Submission and Department Review:
- Harvard Study Submission Guide
- Investigator and Study Staff FAQs
- PI Assurance Quick Reference
- Completing Department Review
- Click here for a complete list of ESTR resources
ESTR Help Desk
Please contact the ESTR Help Desk at ESTRhelp@harvard.edu for ESTR related issues (i.e. access changes, or any system technical issues).