Risk Reporting Methodology

How QA & QC system deviations need to be reported depends on the complexity and duration of the trial. Thus, the ICH E3 guideline states that the regulatory authorities should be consulted for agreeing with a format that will enable the overview of quality management compliance in situations where detailed reports are not practical due to their extent. In such cases, risk reporting would need to be simplified. Therefore, it is not possible to standardize the formats of risk reports.

The MyRBQM® Portal system enables the export of summary tables with the most relevant deviations from the quality control limits based on risk relevance. Thus, it is possible to select deviations of low, medium or high risk, to enable risk report adjustment and simplification. Thus, MyRBQM® Portal improves data visualization as well as communications with and reporting to the regulatory authorities.

Efficacy and safety data should be briefly summarized and depicted in the relevant tables and figures, focusing on any new or unexpected findings. Thus, the KRIs selected by the CYNTEGRITY and its partners are based on key safety and study performance parameters directly related to critical issues such as SAEs, events resulting in withdrawal and deaths, and lack of compliance (i.e., ratio of missing visits).viii

The risk & quality management approach (risk-based QA & QC system) implemented in the trial should always be briefly described in the final Clinical Study Report (CSR). Any important deviation from the predefined quality tolerance limits must be reported together with the corrective actions taken for mitigating risk recurrence (ICH E3, Section 9.6 Data Quality Assurance).[1]

Efforts towards quality assurance and standardization of the clinical study team and investigator performance have great relevance (i.e., audit procedures should be summarized).

[1] ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. International Council for Harmonization (ICH), 30 November 1995.

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