Country-Level IRB Document Configuration

Reference:

Release Notes - SSU

The definition and management of IRB Required Documents at the Country level, expanding beyond the prior constraint of configuring requirements solely at the Study or Site level. This enhancement allows teams to establish precise, country-specific document obligations such as Country Insurance without the use of placeholder document types or manual filing activities. The improvement supports greater accuracy, regulatory alignment, and overall operational efficiency.

A new “Countries” radio button in the Required Documents setup allows admins to select all countries at once or choose specific ones. Different documents can be assigned to different countries (e.g., Document A for all countries, B for Canada, C for the USA, and Germany), providing flexibility to reflect real regulatory variations. Once configured, placeholders automatically appear under each IRB’s Required Documents tab, organized by country.

When IRB or Site approvals occur, these documents are auto-filled into the correct Country category in the eTMF, ensuring proper organization and compliance.

By allowing IRB document setup at the country level, this feature removes manual workarounds, strengthens compliance alignment, and streamlines activation processes, empowering teams to manage global studies more efficiently and accurately.