SIRB Implementation Plan for Study Teams - Step 3
STEP 3: Onboarding Participating Sites
Now that your study has received initial Single IRB approval, it's time to begin onboarding Participating Sites (pSites) for IRB approval.
Each participating site must complete reliance requirements, prepare site-specific documents, submit a Participating Site Application (PSA), receive SIRB approval, and satisfy any local institutional requirements before beginning research.
For Step 4, go to Managing Approved Participating Sites.
Before You Begin
Before onboarding sites, confirm that:
- Your overall study has received initial SIRB approval
- Participating sites have been identified
- Reliance activities have started or been completed
- Site-specific document templates are available
- Participating site investigators have been identified
Most studies onboard sites one at a time or in small batches. Starting early can help your sites begin enrollment sooner.
How long will it take to get IRB approval for each site? This varies greatly by site and depends a lot on your preparation during the Site Assessment phase.
How Site Onboarding Works
1. Complete Reliance and Local Considerations
Before a site can be submitted for SIRB approval, reliance activities must be completed.
What Happens During This Step?
The University of Utah SIRB team works with each site's Human Research Protection Program (HRPP) or IRB to:
- Document reliance arrangements
- Collect local considerations
- Review site-specific requirements
- Confirm the site is ready for SIRB review
How Do I Know a Site Is Ready?
If your study is using IREx, check the Status Summary page.
A site is generally ready for submission when:
- Reliance decision is complete
- Local considerations have been submitted
- Required reliance documentation is in place
- Any requested local information has been provided
TIP: While reliance activities are underway, your team can begin preparing site-specific documents.
2. Prepare Site-Specific Documents
Each participating site typically needs its own version of study documents.
Common Site-Specific Documents
- Consent forms with site contact information, site-specific injury language, HIPAA language, and other locally required language
- Assent forms
- Recruitment materials
Recommended Approach
Start with the SIRB-approved study templates and customize only the sections required for the individual site.
When preparing documents:
- Use the approved template versions
- Make only site-specific changes
- Track all modifications from the approved template
- Retain a clean version and a tracked version
TIP: Many study teams find it useful to prepare site documents while reliance negotiations are still in progress. This can substantially reduce onboarding timelines.
Helpful Resources:
Ensure Site Investigators Have ERICA Access
For studies using the ERICA Site-Control model, site investigators must have ERICA accounts before site applications can be submitted.
Why Is This Important?
Site investigators receive critical communications through ERICA, including:
- Approval notifications
- Requests for revisions
- Continuing review reminders
- Compliance notifications
- Study updates
Before proceeding, verify that:
✅ Site Principal Investigator has created an ERICA account
✅ Site Principal Investigator can access ERICA
✅ Site contact information is accurate
✅ Required personnel have appropriate access
3. Submit the Participating Site Application (PSA)
Once reliance activities are complete and documents are prepared, submit the Participating Site Application.
In ERICA:
- Open the study.
- Select the Sites
- Choose the participating site.
- Open the Participating Site Application.
- Complete required site information.
- Upload site-specific documents.
- Submit the application for SIRB review.
Include:
- Site-specific consent forms
- Recruitment materials
- Site-specific documents required by the site
- Any other documents requested by the SIRB
When document changes have been made from approved templates, provide both:
- A clean version for approval
- A tracked version showing changes
What Happens After Submission?
After the PSA is submitted:
SIRB Review
The SIRB reviews:
- Site-specific documents
- Local considerations
- Site-specific requirements
- Reliance documentation
You may be contacted if revisions are needed.
4. Site Approval
Once approved:
- A site-specific approval letter is issued.
- The participating site receives SIRB approval.
- The site can move toward local activation requirements.
Important: SIRB Approval Does Not Automatically Mean the Site Can Begin Research
Even after SIRB approval, participating sites may have local requirements that must be completed before research activities begin.
Examples may include:
- Local HRPP reviews
- Institutional approvals
- Ancillary committee reviews
- Site-specific startup requirements
Before Enrollment Begins
Confirm that the site has:
✅ SIRB approval
✅ Completed required local reviews
✅ Received any required activation notice
✅ Met institutional startup requirements
Site Onboarding Checklist
Download Word Version for printing
Use this checklist as you prepare each site for participation:
Reliance
Documents
Personnel & Systems
SIRB Submission
Site Activation
Frequently Asked Questions
-
Yes. Each site receives its own Participating Site Application and approval determination.
-
Yes. We encourage study teams to prepare site-specific documents while reliance activities are underway.
-
Not always. Site-Control model studies require ERICA access for site personnel involved in site-specific applications.
-
Generally, the site's reliance decision and local considerations must be complete before submission for approval.
-
Not necessarily. The site must also satisfy any locally required activation or HRPP requirements.
Next Step
For Step 4, go to Managing Approved Participating Sites.
After your sites are approved, learn how to:
- Submit site amendments
- Report site-specific issues
- Manage continuing reviews
- Close participating sites
- Maintain compliance throughout the study lifecycle