P239: Integrating RBQM (Risk Based Quality Management) into CRF (Case Report Form) Design

Poster Presenter

Johann Proeve

Chief Scientific Officer
Cyntegrity
Germany

Objectives

To identify the critical linkage between CRF design and the effective implementation of Risk Based Quality Management (RBQM), ensuring a smooth interoperability between the data captured on CRFs and the analyses performed by an RBQM system

Method

A comprehensive review was conducted of study CRFs (Case Report Forms) and protocol-specified data against the risks and the critical-to-quality factors (CTQs), i.e. critical data and processes, identified by the study teams.

Results

The review of the protocols, CRFs and database structures, and the comparison to the datapoints required to manage the risks in a study, revealed many disconnects between the data available and the data required, limiting the impact of RBQM on data quality. Specifically, identified discrepancies included: • Data gaps, such as missing IP (Investigational Product) related information within the CRF, limits the ability to track and manage IP-related risks, e.g. storage. • Lack of access to the EDC (Electronic Data Capture) audit trail complicates the calculation of data entry delays, limiting the potential for quality improvements. • Late availability of critical data (e.g. lab, ECG, or biomarker data), prevents early interventions to ensure patient safety. These findings demonstrate that RBQM can only be effectively implemented when the data for the KRIs (Key Risk Indicators) are available in comprehensive, electronically captured datasets.

Conclusion

In many companies CRF design is only initiated once the protocol is nearly finalized. The same is true for the implementation of RBQM. This process requires a substantial change, particularly in light of the ICH-required implementation of ‘Quality-by-Design’ (QbD). Embracing QbD will require organizations to facilitate early collaboration among teams involved in protocol development, CRF design, and RBQM implementation. This proactive integration ensures that study planning and CRF design will align with critical data requirements, thus reducing the burden on site staff and patients, ensuring patient safety, enhancing data quality and integrity of results, and ultimately meeting the required ICH E6 R3 and ICH E8 R1 regulatory standards.