SIRB Implementation Plan for Study Teams - Step 4
STEP 4: Managing Approved Participating Sites
Your participating site has received SIRB approval. Now it's time to manage the site throughout the life of the study.
As the lead study team, you are responsible for keeping site information current, ensuring required submissions are made on time, maintaining site-specific documents, and communicating important study changes to participating sites.
This page will help you:
- Submit site amendments
- Manage continuing reviews
- Report site-specific issues
- Update site documents
- Close participating sites
- Maintain compliance throughout the study
For Step 5, go to Completing Ongoing SIRB Responsibilities.
Managing Sites Throughout the Study Lifecycle
Approved sites continue to require ongoing oversight and communication.
Step 4A: Submit Studywide and Site-Specific Amendments
The IRB must review and approve any modification to research activities or amendments involving changes to an IRB-approved protocol or document prior to implementation, unless changes are necessary to eliminate immediate hazards to subjects. (In those cases, reporting is still required after the change is made.)
These changes can be minor or significant, and can affect the entire study, a few sites, or only one site. Changes at any level require SIRB review and approval before implementation.
Common Site Amendments:
- Updated consent forms
- Revised recruitment materials
- Changes to site-specific procedures
- Changes to site Principal Investigator
- Changes required by local HRPP review
- New site-specific documents
Before Submitting an Amendment
Ask:
- Does the change affect only one site?
- Does the change affect all sites?
- Does the change require updates to approved documents?
If you are unsure, contact the SIRB team before implementing the change.
Resources:
- Learn how to Submit a Studywide Amendment.
- Learn how to Add a pSite for Site-Control Management.
- Learn how to Submit an Amendment for a PSite only.
IMPORTANT: Do not implement changes to approved site materials until the SIRB has approved the amendment, unless immediate action is required to eliminate an apparent hazard to participants.
Step 4B: Manage Continuing Reviews and Progress Updates
Depending on your study and regulatory requirements, your study may require continuing review or periodic progress updates.
What You May Need to Report:
- Enrollment numbers
- Participant withdrawals
- Study progress
- Site-specific issues
- Changes in risk
- Study status
Your Responsibilities:
- Monitor study expiration dates.
- Collect information from each participating site.
- Submit required reports before deadlines.
- Ensure site personnel respond promptly to requests for information.
Resources:
- Learn more about Continuing Reviews and Progress Updates.
- Learn how to Submit a Continuing Review or Progress Update for a Site-Controlled Study.
Helpful Tip: Create a schedule for collecting site updates well before submission deadlines. This can help avoid delays in review and approval.
Step 4C: Report Site-Specific Issues
Certain events occurring at a participating site must be evaluated and may require reporting to the SIRB.
Examples May Include:
- Unanticipated problems
- Protocol deviations
- Noncompliance
- Participant complaints
- Suspensions or terminations
- New local requirements affecting the study
When an Issue Occurs:
- Gather information from the site.
- Determine whether reporting is required.
- Submit required reports promptly.
- Communicate with the affected site as needed.
Resources:
- Learn how to Prepare and Submit a Report Form.
- Learn how to determine whether an event may be an Unanticipated Problem (UP).
- Learn more about managing a Breach of Confidentiality or Privacy.
- Read more guidance about Reportable Events from SMART IRB.
Remember: Participating sites often have their own local reporting requirements in addition to SIRB requirements.
Step 4D: Update Site Documents
Throughout the study, approved documents may need to be updated.
Common Documents Requiring Updates
- Consent forms
- Recruitment materials
- Participant handouts
- HIPAA documents
- Site-specific language
- Contact information
Best Practices
- Maintain both tracked and clean versions.
- Keep site-specific language separate from study-wide changes when possible.
- Verify that each site is using the most recently approved version.
Resources:
- Learn more about Submitting Documents for IRB Approval.
Step 4E: Manage Local HRPP Requirements
SIRB oversight does not replace all local institutional responsibilities.
Participating sites remain responsible for complying with local requirements throughout the study.
Local Responsibilities May Include:
- HRPP reviews
- Ancillary approvals
- Training requirements
- Conflict of interest management
- Institutional reporting requirements
As the Lead Study Team
Maintain regular communication with participating sites to ensure local obligations continue to be met.
Step 4F: Close Participating Sites
When a participating site completes all study activities, it may be eligible for closure.
A Site May Be Ready to Close When:
- Enrollment is complete
- Interventions are complete
- Follow-up activities are complete
- No additional IRB oversight is needed
- Site-specific research activities have ended
Before Requesting Closure
Confirm:
- Required data collection is complete.
- Site personnel no longer require study access.
- Local institutional obligations have been satisfied.
- Any required closure reports have been completed.
Resources:
- Learn more about the criteria for closing a Participating Site or Study.
- Learn how to Close a Participating Site.
IMPORTANT: Closing a site does not necessarily close the overall study. Other participating sites may continue operating under the SIRB approval. Fees may be applicable at the time of closure.
Maintaining Compliance Throughout the Study
Successful multisite studies depend on consistent communication and oversight.
Recommended Practices
- Review site statuses regularly
- Track upcoming reporting deadlines
- Maintain current contact information
- Monitor document versions
- Respond promptly to site questions
- Document important communications
- Address issues early
- Keep participating sites informed about study-wide changes
Managing Multiple Sites
As the number of participating sites grows, organization becomes increasingly important. Consider Tracking and Regularly Updating
| Item | Example |
|---|---|
| Site status | Approved, enrolling, closed |
| Site PI | Current site investigator |
| Enrollment | Current enrollment count |
| Approval dates | Initial approval and renewals |
| Local HRPP activation | Complete or pending |
| Site-specific amendments | Open or approved |
| Continuing review status | Submitted or pending |
| Key contacts | Site coordinators and HRPP contacts |
Frequently Asked Questions
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Many do. Changes affecting approved site information, documents, or procedures should generally be reviewed before implementation.
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Yes. Site-specific language is often required to address local policies and requirements.
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The change should be submitted and approved according to SIRB procedures before the transition is finalized.
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Yes. Participating sites may be closed individually while the overall study remains open.
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The lead study team is responsible for coordinating communication and oversight across participating sites.
Next Step
For Step 5, go to Completing Ongoing SIRB Responsibilities
Learn how to:
- Add new participating sites
- Manage study-wide amendments
- Coordinate multisite communications
- Prepare for study closure
- Maintain records and regulatory documentation
- Successfully complete your SIRB study lifecycle