Regulatory requirements for Oracle InForm User Management Tool

You or your delegate are responsible for:

• Ensuring that appropriate regional regulatory approvals are in place before allowing a site access to the initial study version or to any subsequent functionality changes (for example, a later study version, which may have resulted from a protocol amendment).

  This includes ensuring that regional regulatory approvals are in place for any study version, even if the study version wasn't yet made available to the site. For example, if you're associating a site to study version three, but the site was not yet associated to study version two, consider whether appropriate regional regulatory approvals are in place for study version two for that site before associating the site with study version three. This is because associating study version three to the site will incorporate the functionality changes for study version two as well as study version three.

• Ensuring that any user account created through Oracle InForm User Management Tool accurately reflects the user's training status for the product. Before distributing Oracle InForm or Oracle IRT account details to a user, you must mark the user as Trained in Oracle InForm User Management Tool.

These regulatory requirements apply for all Oracle InForm User Management Tool integrations, specifically Oracle InForm and Oracle IRT.