The Implementation Checklist

Applies to: Agreement V3.0

The Implementation Checklist is a one-stop form for recording how two institutions will implement the Agreement for a study or group of studies. It lists every flexible provision of Version 3.0 and lets the institutions mark which apply.

Who completes it. The Reviewing IRB's Point of Contact and the Relying Institution's Point of Contact, together. It is optional but encouraged whenever anything other than the default applies, so that everyone involved knows the terms in force.

What it records - Whether the arrangement is a default implementation (standard terms; nothing else to document) or a flexible implementation. - Which SOPs govern (SMART IRB SOPs, the Reviewing IRB's, or externally mandated policies). - HIPAA responsibilities — who makes waiver/alteration determinations and whose authorization language is used. - Whether the insurance requirement is waived. - Whether the Indemnification Addendum applies, is excluded, or another indemnification arrangement is used. - Who drafts and submits external reports. - Conflict-of-interest, fee, and consent-customization arrangements. - Any Mandated Processes or Policies that apply.

Validation and signatures. The form offers options for IRB/HRPP staff to validate or sign. Some institutions require signatures on reliance documents and others do not allow them; edit the block to match your policy.

When to use it instead of an LOA. Use the checklist for consortium- or network-level arrangements you want to settle once, and for Reliance System requests, where it complements the determination letter. For a single study documented outside the Reliance System, the Flexible LOA covers the same ground in one document. IREx users record the same choices in the Study-Specific Reliance Plan.

See also - Default vs. flexible implementation - The Letter of Acknowledgment (three versions) - The SMART IRB SOPs: what they are and when they apply