Huron IRB - Create Site Modifications for Single-Site or Multi-Site External Study

Overview

Site modifications can be made to active external studies in two categories:

• Local study team and research location information
• Other parts of the local site (including basic site information, additional local funding sources, and local site documents)

These modifications can be performed by the local Principal Investigator (PI) and local study team members.

Creating a Site Modification

1. In the Top Navigator, click IRB and then Submissions.
2. Click the External IRB tab and open the study.
3. Click the Create Site Modification button. 
4. Select Modification/Update for the purpose of the modification.
5. Select the Modification Scope.
   1. Study team and research location information.
   2. Other parts of the site.
6. Click Continue and complete all remaining pages
7. Click Finish on the last page.

Submitting Your Modification

1. From the site workspace, the PI should click Submit.
2. Review and click OK to agree to the attestation.

After Submission

Your modification has been submitted to the local IRB. You can safely log off the system.

To locate your modification later, return to the site workspace and click the Follow-On Submissions tab.