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Home Getting Started SIRB Implementation Plan – Step 5

STEP 5: Completing Ongoing SIRB Responsibilities

Your study is underway, participating sites are active, and the University of Utah is serving as the Single IRB (SIRB). The final step is maintaining study-wide oversight and ensuring all participating sites remain compliant throughout the life of the study.

As the Responsible Principal Investigator (R-PI) or lead study team, you are responsible for coordinating activities across participating sites, communicating important updates, maintaining study records, and bringing sites and the study to a successful close.

Study-Wide Oversight Responsibilities

Once participating sites are approved and activated, your role shifts from startup activities to ongoing study management.

As the Lead Study Team, You Are Responsible For:

  • Coordinating communication across participating sites
  • Implementing approved study-wide changes
  • Monitoring site compliance and reporting obligations
  • Maintaining regulatory documentation
  • Adding new sites when needed
  • Managing site and study closure activities

Study Lifecycle

Step 5A: Add New Participating Sites

Many multisite studies continue adding participating sites after initial approval.

Before Adding a New Site

Confirm:

  • The institution has agreed to participate
  • Appropriate site personnel have been identified
  • Reliance can be established
  • Site-specific documents can be prepared

Process for Adding a New Site

  1. Add the site to the study.
  2. Complete reliance activities.
  3. Collect local considerations.
  4. Prepare site-specific documents.
  5. Submit the Participating Site Application (PSA).
  6. Obtain SIRB approval.
  7. Complete local activation requirements.

New sites follow the same onboarding process described in Step 3: Onboarding Participating Sites.

Helpful Tips: If your funding plan anticipates future site expansion, prepare onboarding materials early to reduce startup timelines. Budget extra to cover additional SIRB initial site and annual review fees.

Step 5B: Manage Study-Wide Amendments

Some changes affect the entire study rather than a single site.

Common Study-Wide Amendments:

  • Protocol revisions
  • Changes to study procedures
  • New recruitment strategies
  • Updated consent templates
  • Expanded eligibility criteria
  • New study documents
  • Additional study activities

After Approval

When a study-wide amendment is approved:

  • Review the approval letter carefully.
  • Identify which sites are affected.
  • Notify participating site teams.
  • Update site-specific documents when necessary.
  • Track implementation across sites.

Best Practice

Maintain a centralized change log documenting:

  • What changed
  • Approval date
  • Sites affected
  • Date each site implemented the change

 

Step 5C: Coordinate Communication Across Participating Sites

Consistent communication is one of the most important factors in a successful multisite study.

Topics That Should Be Communicated Promptly

  • Approved amendments
  • Protocol changes
  • Safety information
  • Reporting requirements
  • Enrollment goals
  • Study milestones
  • Upcoming deadlines

Recommended Communication Methods

  • Monthly coordinator meetings
  • Site newsletters
  • Study update emails
  • Regular investigator calls
  • Shared project workspaces

Remember: Participating sites cannot comply with requirements they are unaware of. Timely communication helps maintain compliance across the entire study network.

 

Step 5D: Maintain Regulatory Documentation

Multisite studies generate a substantial amount of documentation over time.

Recommended Records

  • Protocol approvals
  • Site approval letters
  • Reliance documentation
  • Site correspondence
  • Amendment approvals
  • Continuing review records
  • Reportable event documentation
  • Site activation records
  • Site closure records

Documentation Best Practices

  • Maintain version control
  • Store records in a centralized location
  • Retain historical approvals
  • Archive superseded documents
  • Document important decisions and communications

Helpful Tip: Many study teams organize records by participating site and then further organize by approval type, amendment, reporting, and closure activities.

Step 5E: Monitor Study-Wide Compliance

Compliance should be monitored throughout the study, not only when reporting deadlines approach.

Areas to Review Regularly

  • Site approval status
  • Enrollment activity
  • Training requirements
  • Reporting deadlines
  • Required approvals
  • Approved document versions
  • Site-specific compliance issues

Questions to Ask Regularly

  • Are all sites currently approved?
  • Are sites using the most recent approved documents?
  • Have required reports been submitted?
  • Have study-wide changes been implemented consistently?
  • Are there unresolved site-specific issues?

Recommended Practice

Schedule periodic reviews of participating site status to identify and address problems early.

Step 5F: Prepare for Site and Study Closure

Eventually, participating sites and the study itself will complete all research activities.

Closing Individual Participating Sites

A participating site may be eligible for closure when:

  • Enrollment is complete
  • Study interventions are complete
  • Follow-up activities are complete
  • Required reports have been submitted
  • No further IRB oversight is needed

Participating sites may close at different times while the overall study remains active.

Closing the Entire Study

Before closing the study, confirm:

  • All participating sites have been closed or transitioned appropriately
  • Enrollment is complete
  • Follow-up activities are complete
  • Required reporting is complete
  • Regulatory obligations have been satisfied
  • Study records have been organized and retained appropriately

IMPORTANT: The study should remain open until all activities requiring IRB oversight have been completed.

Multisite Study Management Checklist

Study-Wide Oversight

☐ Maintain site tracking records

☐ Monitor site approvals

☐ Track key deadlines

☐ Communicate study updates

Regulatory Management

☐ Retain approval documentation

☐ Maintain reliance records

☐ Archive superseded documents

☐ Maintain version control

Compliance Monitoring

☐ Review approved document versions

☐ Monitor reporting requirements

☐ Address site-specific issues

☐ Document corrective actions

Closure Activities

☐ Close participating sites as appropriate

☐ Complete required closure reports

☐ Retain study records

☐ Archive final documentation

Frequently Asked Questions

  • Yes. New sites can typically be added throughout the life of the study following the standard onboarding process.

  • Provide clear information regarding what changed, which sites are affected, when implementation may begin, and any actions required by site personnel.

  • Yes. Individual sites may close while the overall study remains active.

  • The Responsible Principal Investigator (R-PI) and lead study team are responsible for coordinating communication and oversight across participating sites.

  • The study may close when all participating sites have completed required activities and no further IRB oversight is required.

Congratulations!

You have reached the final step in the University of Utah SIRB process.

By following these steps, you can successfully:

 

 

Need Help?

The University of Utah SIRB Reliance Team is available to assist with:

  • Adding participating sites
  • Reliance questions
  • Site onboarding
  • Amendments
  • Continuing review requirements
  • Study-wide changes
  • Site and study closure planning

Contact the SIRB Reliance Team if you need assistance at any stage of the Single IRB process.

 

Do you need assistance from our team?

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