Applies to: Agreement V3.0 · SMART IRB SOPs
Most problems in single IRB review are communication problems. The Communication Plan (also the appendix to the SMART IRB SOPs) is a template for writing down, for one study, who is responsible for each communication between the Reviewing IRB, the Lead Study Team, and each relying site.
The four roles it names
| Role | Main responsibility |
|---|---|
| Reviewing IRB POC | Questions about the Reviewing IRB's policies, procedures, and review status |
| Lead Study Team representative | Communication with the Reviewing IRB; relaying between relying sites and the Reviewing IRB |
| Relying Site POC | Communication with the Reviewing IRB and the local study team about the ceded study (usually the local IRB/HRPP office) |
| Relying Site Study Team representative | Communication with the Lead Study Team |
What it assigns. For each of about seventeen recurring tasks — submitting the study-wide and site-specific IRB applications, providing COI management plans, confirming training, collecting and forwarding local considerations, distributing approved documents and consent templates, incorporating site-specific consent language, continuing review, reportable events, closure — the plan records which role is responsible, with the SMART IRB SOPs' typical assignment marked as a starting point, and a notes column.
The communication model. The SOPs assume a hub-and-spoke pattern: relying sites communicate with the Lead Study Team, the Lead Study Team communicates with the Reviewing IRB, and IRB/HRPP offices communicate POC to POC. The Communication Plan is where a study writes down any departures from that pattern.
How to use it. Complete it at the start of a study and keep it current. Reviewing IRBs and HRPPs may also use it to set general expectations for all ceded studies. It is meant to be customized — see Customize SMART IRB resources for your institution for a worked example.
See also - Amendments and personnel changes - Customize SMART IRB resources for your institution - Overall PI and Lead Study Team checklist
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