Submitting Participating Sites for UU SIRB Approval
STEP 1: Gather Documentation
Each site that is participating in your study will likely have documents that need to be customized to adhere to local policies. For example, if you are using a consent document to obtain consent from participants, there may be local language requirements that must be included (e.g. person to contact, research-related injury, HIPAA authorization language, etc.). There may also be local laws or policies that require specific verbiage be included in the documents.
If you are using recruitment materials (e.g. flyers, advertisements, etc.) they may also require site-specific customization.
STEP 2: Prepare Your Documents for IRB Processing
The IRB's electronic application system will mark certain types of documents with an approval stamp during final processing.
Consent Documents of any kind are the most common type of document that requires an IRB stamp. If you have another document type that you believe needs to be stamped by the IRB, please contact us for guidance.
learn how to submit documents for irb approval
STEP 3: Submit the Site Application in ERICA
- After you have prepared the site's customized documents, go to your study in ERICA.
- From the study's main workspace, navigate to the "Sites" tab to see a list of all
of your sites. Select the site you want to submit by clicking the link in the "Site"
column.
- In the site application, click "Edit Application" and fill out the site application.
- On the Site Information page, make sure the site Principal Investigator (PI) has activated their ERICA account.
If the site PI is listed in the box highlighted in green below, they have successfully activated their ERICA account and will be able to receive
notifications and submit site information.
If the site PI is listed in the boxes highlighted in pink below, they need to be moved to the green box, or if you cannot search for them in the green box, they need to activate their ERICA account. Email your UU IRB staff contact for assistance in this case.
- On the Site Information page, make sure the site Principal Investigator (PI) has activated their ERICA account.
If the site PI is listed in the box highlighted in green below, they have successfully activated their ERICA account and will be able to receive
notifications and submit site information.
- Attach site-specific documents (e.g. consents, recruitment materials, etc.) to the Documents and Attachments page as appropriate.
- When ready, make sure the site PI and/or Responsible Investigator (i.e. study lead PI) submit the site application to the IRB for review/approval.
STEP 4: Track Your Site Application's Progress
You can track each ERICA application's progress by checking the status label. Use the ERICA Status Key find out where your application is in the review process.