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An ongoing pivotal, randomised controlled trial is being conducted to test the safety and efficacy of cardiac radioablation (CRA). The study compares treatment with a medical device to repeat catheter ablation (CA) for patients with high-risk refractory ventricular tachycardia (VT) who experienced VT recurrence after CA and are candidates for additional CA. This is a multi-centre global study with 380 randomised patients across 20+ sites in the United States, United Kingdom and Germany, carried out over 7.5 years. 

During the first monitoring trip reports it became clear that monitors were not providing sufficient detail in the dynamic trip report. Due to the trial¡¯s complexity, more information about the conduct of the site visits was required to support analysis. The monitoring plan did not outline the sponsor¡¯s specific requirements, resulting in the omission of essential details.  

In collaboration with the sponsor, ÃÛÌÒ´«Ã½ developed an annotated trip report guidance document for monitoring visit trip reports. The document provided more detailed directions on the information to be gathered in each monitoring visit trip report. This step strengthened the partnership with the sponsor and avoided delays due to follow up queries and reviews. 

The annotated trip report guidance document clarified expectations for data capture and ensured that all relevant information is gathered and included in trip reports. The guidance document was aligned with the sponsor expectations resulting in fewer queries and action items. As the study progresses, the trip review process continues to improve with increasing efficiencies. Documentation is more concise, relevant and in compliance with the monitoring plan. By reducing the number of queries and reviews in this complex trial, reports are finalised more quickly.