The Quality Assurance (QA) module is comprised of several functions which include: calculation of protocol risk scores, calculation of hazard designation, and support for review of Investigators across studies to support risk assessment. The module also performs auditing and contains Quality Monitoring Worksheets used during audits.
The system is built on best practice form sets that have been developed in collaboration with large and small institutions. These forms can be used out of the box to save configuration time; or they can be tailored to institutions requirements. Our Form Designer allows for smart form development that include functions for show/hide of sections and questions, questions validations, branching logic to skip sections and questions that are not applicable, Online Help Text, and PDF print friendly to merge web forms direct to PDF. These functions streamline the process to aid the research team in filling out forms for submission, creating quality submissions for the QA office to review.
QA also possesses a workflow of form navigation through the system. This includes defining the review process for risk scores, sending automatic email alerts to remind personnel to revisit studies under high risk, and setting up rules to monitor risk and trigger possible audit condition matches, and generating management plans.