How to Enable and Access the Protocol Analysis Tool

To use the Protocol Analysis Tool, it must first be enabled in your Company Settings by your Administrator (This functionality is disabled in MyRBQM by default).

To enable the Protocol Analysis Tool for those users assigned the privilege:

Navigate to Company ManagementManage AI functionality and check the box labeled Use Protocol Analysis Tool (see below).

Carefully read and accept the terms of use before enabling the Protocol Analysis Tool.

  1. Once the Protocol Analysis Tool has been enabled, navigate to the study for which you want to create or enhance the Risk Assessment.
  2. Click on the Risk Management menu drop-down item: Protocol Analysis, as below.

Note:

  • Step 1: Protocol Complexity Assessment is available to all users (once enabled).
  • Once enabled, Step 2: AI-Enhanced Critical to Quality (CtQ) Identification requires the privilege Generate AI Critical Processes and Data.
  • Once enabled. Step 3: AI-Enhanced Risk Assessment Generation requires the privilege Generate AI Risk Assessment.
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