Central IRB Studies: Local IRB Process & Required Documents

When working with a Central IRB, there are several key steps and documents required to ensure your study is properly reviewed and documented at the local level before moving forward. This process establishes institutional oversight while allowing the Central IRB to serve as the IRB of record.

Required Non-UVA Documents for Initial Local IRB Submission

For studies relying on a Non-UVA(Central) IRB, the initial submission to the local IRB focuses on non-UVA IRB documents. Study teams should be prepared to provide:

• The Sponsor’s initial IRB approval and the most recent continuing review approval
• Reliance Agreement Request form generated through Protocol Builder
• Local Language Consent reflecting site-specific requirements (needed for BCA only)

These documents allow the local IRB to determine whether reliance on the Central IRB is appropriate.

Important: Uploading the local language consent in the non-UVA IRB Documents in CRConnect is required along with the Finance and budget steps to trigger the BCA workflow in CRConnect., The BCA step will not open if the local language consent is not uploaded in non-UVA IRB Documents, which may delay getting a BCA.

In addition to the Non-UVA IRB specific documents you must also complete all other steps in CRConnect and provide the following documents:

• IRB Protocol coversheet
• Non-UVA IRB application (WORD version)
• Data Security plan (CRConnect version. Protocol Builder version should be discarded)
• Requirements for any ancillary approvals (e.g. HIRE, PRC, IBC, InfoSec)
• Current Version of the Sponsor protocol (non-UVA protocol)

Local IRB Review & Cede Letter

Once submitted, UVA IRB will review the materials to confirm reliance eligibility.

If approved, the IRB will issue a cede letter, documenting that oversight has been ceded to the Central IRB.

The cede letter will be uploaded into IRB Pro, where study teams can access it for their records and next steps.

Central IRB Submission

After receiving the cede letter, study teams can proceed with submitting to the Central IRB for site-specific approval.

The Central IRB will require the cede letter as confirmation that local oversight has been established.  If the IRB of record is at an academic center, the IRB of record will need to sign the cede letter and the fully signed cede letter will be returned to the IRB-HSR, where it will be uploaded to IRB Pro.

Final Step: CRConnect Submission

Once Central IRB approval is obtained upload the Central IRB approval into CRConnect

This step ensures the study is fully documented locally and ready to move forward operationally.

Process Summary

1. Submit non-UVA IRB documents to the local IRB
2. Receive the cede letter
3. Submit to the Central IRB for site approval/ signature
4. Upload Central IRB approval in CRConnect to complete local requirements and wait for UVA IRB approval.

Need Help?

For additional guidance, please refer to the Non-UVA IRB Documents tip sheet or contact CRConnect Support. For IRB specific guidance visit:  HRPP Reliance on a Non-UVA IRB