IRB Forms
For Continuing Review and Study Closure
For email submissions
Continuing Review and Renewal Form
For Kuali submissions
To submit a renewal if the initial approved protocol was submitted via Kuali, open the proper submission and click “Renew” in the upper right-hand corner of the screen. Complete the renewal questions and submit.
To submit a study closure if the initial approved protocol was submitted via Kuali, open the proper submission and click “Closeout” in the upper right-hand corner of the screen. Complete the form and submit.
Note: If you select "Amend" or "Renew and Amend" you will be able to make changes to your protocol details. If you select "Renew or Closeout" you will only be able to fill out the supplemental information form that appears at the top of your application. The other aspects of the submission lifecycle are identical to a New Protocol.
For Initial Protocol Submissions
For Modifications to Submissions
For email submissions
If the initial approved protocol was submitted via email, please fill out the Protocol Modification Submission Form and email modification requests to irb@ccsu.edu.
For Kuali submissions
If the initial approved protocol was submitted via Kuali, open the proper submission and click on “Amend”. Select which sections you would like to modify. Make sure to “Replace” attachments and not delete them. Then click “submit” or “Notify PI to Submit” depending on your role.
The selected sections will be locked from further editing until the amendments are reviewed. Step by step directions.
For Adverse Events
For email submissions
For Kuali submissions
If the initial approved protocol was submitted via Kuali, open the proper submission and click on the “Reportable Events” tab at the top of your protocol. Select “Report an Event”, complete all fields, and then “Submit for Review”.
COVID-19 Research Safety Application and Information
Due to the ongoing COVID-19 pandemic, CCSU’s Institutional Review Board (IRB) is now reviewing in person research for COVID-19 safety considerations in addition to our normal review procedures which focus on the rights and welfare of human participants.
The IRB, in consultation with the AVP for Graduate Studies, Research, and Faculty Development and the Provost, have determined this extra review step is necessary due to a composite of factors, including:
- Concern for the safety of the campus community;
- Concern for the safety of researchers and research participants;
- The potential impact of increased usage and cleaning of classroom and laboratory space;
- The increased need for PPE; and
- The possible increased HVAC circulation requirements for research laboratories.
Recognizing that some research questions cannot be addressed using virtual research techniques, the IRB has implemented this extra layer of review for researchers who wish to initiate or resume in-person research activities.
To begin the safety review process for in person research, please review the IRB COVID-19 documents found below and complete the CCSU IRB COVID-19 Research Safety Application Form appropriate for your research (either for new studies or ongoing studies). Submit your completed form and all required supplemental materials to irb@ccsu.edu.
If you are planning to conduct in-person human subjects research and are submitting an initial protocol submission form via the Kuali Protocol Portal, please be sure to add this COVID-19 form as an attachment under the section titled “Attachments”.
Please contact the IRB at irb@ccsu.edu with any questions about this application process.
CCSU IRB COVID-19 Research Safety Application Form – for NEW STUDIES
CCSU IRB COVID-19 Research Safety Application Form – for ONGOING STUDIES