IRB Reliance Agreements/IRB Authorization Agreement/Cooperative Agreement

[Anne Poliner]

Is there a standard zone for IRB Reliance Agreements?

Option 1:
04.01.05 IRB or IEC Compliance Documentation
Documentation that the IRB/IEC is performing its function according to written operating procedures and is in compliance with GCP and applicable regulatory requirements.

Option 2:
04.04.01 Relevant Communications
Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.

Thank you!

[Todd Tullis]

My understanding of these agreements is that they are a better fit in Relevant Communications (despite generally trying to avoid that artifact) because the nature of an agreement has some kind of scope whereas “Compliance Documentation” is for the IRB as a whole.

Depending on your perspective I could see it falling into either Zone 4 (if you are a sponsor and filing a reliance agreement for an IRB that will cover multiple sites) or Zone 5 (if you are a sponsor and filing a reliance agreement for a single site’s local IRB).

[Author]

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