IQRMP Report

MyRBQM^® Portal documents all RACT data of a study in the Integrated Quality Risk Management Plan (IQRMP). Each released RACT or its latest working draft summary can be exported as an excel file.

To download a report for your study in Excel format:

1.           Inside a study go to Risk Management → RACT

2.           In the Risk Management Overview, select the needed release or a working draft

3.           Click Download IQRMP Report

Excel reports are structured in thematic worksheets listing the History, Risk Assessment, Critical processes, Critical data, KRI and QTL.

1. History Worksheet:
   1. IQRMP Report section: study ID and name, an overview of the account details of the user that downloaded the excel report and the version number of the downloaded report.
   2. Release History section: provides information about the all previous reports version numbers, their release dates, by whom the reports were released and their release notes.
2. Risk Assessment Worksheet: detailed information about the RACT version, implemented risk categories, questions, risk assessment guidelines, their risk score, from which the overall risk level is calculated and full information about each mitigation action created.
3. Critical processes Worksheet: summarizes all applied critical processes of the study with their names and descriptions.
4. Critical data Worksheet: information about the calculated critical data of the study, their labels and descriptions.
5. KRI and QTL Worksheet: the list of all the KRI their ID, the brief description of how it is calculated, an associated risk (if any), the actual thresholds (medium, high) for each level (site, study, etc.) along with the mitigation IDs and review timelines associated with KRI.