Helping you implement ICH GCP R2 changes with iQROS™ software
Clinical trials have seen significant advances in the technology used since the ICH GCP document was first released. Electronic data recording. Centralized monitoring. The landscape has evolved, and recently the ICH GCP has been updated to align the standards of good clinical practice with a more modern world.
Clinical trials have seen significant advances in the technology used since the ICH GCP document was first released. Electronic data recording. Centralized monitoring. The landscape has evolved, and recently the ICH GCP has been updated to align the standards of good clinical practice with a more modern world. iQROS™ is Kestrel Biologic’s Risk-Based Monitoring software that can get you up to speed with both RBM and the new additions to the ICH GCP, quickly and seamlessly.
Foremost amongst the additions is a large section on Quality Management, which covers the sponsor’s obligation to assess and address risks. Specifically, it outlines the following steps:
- Critical Process and Data Identification
- Risk Identification
- Risk Evaluation
- Risk Control
- Risk Communication
- Risk Review
- Risk Reporting
In the words of the ICH, “The quality management system should use a risk-based approach.”
iQROS™ covers this stepwise approach fully within the system in an integrated fashion. iQROS™ documents identified risks along with relevant information related to each risk. A Failure Modes Effect Analysis (FMEA) scoring of the risks helps with their evaluation. The system then documents the control of the risks by linking specific mitigations to each risk. Mitigations are the specific tasks which will be undertaken as part of the implementation of the trial, thereby controlling the risks. Additional FMEA scoring is done to show the expected effects of the mitigations and to help confirm that those plans are in place.
Using iQROS™, the sponsor has oversight and control of the risk mitigation process at a level never before achievable. The study team can output the risk plan itself. Then using our template or customized text, they document all related activities in real time. New risks and mitigations can be added seamlessly on an ongoing basis. This creates a fully audit trailed record in one centralized location. The study team tracks activities not just of the CRAs and monitoring team, but all other groups that undertake oversight including centralized monitors, data management entities, pharmacovigilance departments and other vendors right in the system.
A second major addition to the ICH GCP is a section on Monitoring which introduces the concept of risk-based monitoring. It describes a flexible approach that can include a variety of different methods, including centralized monitoring. With iQROS™, the detailed monitoring plan is fully integrated with all other oversight activities. It allows the study team to dedicate specific tasks to different groups and document all their activities. It automatically tracks progress and can trigger different responses based on site status within a study.
The iQROS™ system shows monitoring progress and fully documents it in monitoring reports. It tracks all issues to conclusion and provides a detailed history of issues, actions taken, mitigation and workflow for noncompliance reporting. Even signatures are fully electronic, providing one centralized, integrated system for an efficient, transparent, and fully documented study.
Full implementation and ongoing support is available for your organization through Kestrel Biologic, helping you seamlessly incorporate the most advanced and comprehensive RBM software available for the highest quality studies.
Contact Lorne Cheeseman at email@example.com for more information and to discuss how iQROS™ can bring your studies into the modern world.