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Clinical Research Coordinator Analysis

Radiographic Tumour Assessment Scheduling

Finding: Section 6.5.1 specifies that subsequent tumour assessments are performed every 6 weeks (± 7 days) "relative to the date of the previous planned tumour assessment." The protocol also allows for "unscheduled tumour assessments...if clinically indicated." If an unscheduled assessment is performed due to suspected progression but does *not* confirm Progressive Disease (PD), it is unclear whether the subsequent 6-week assessment interval should be calculated from the date of this unscheduled assessment or if it should revert to the original schedule based on the last *planned* assessment. This ambiguity can lead to inconsistent scheduling practices across sites, potential for missed windows, and impact the precise timing for progression evaluation. Recommendation: Provide explicit guidance, potentially via a protocol amendment or a study manual clarification, on how to schedule the next tumour assessment following an unscheduled assessment that does not confirm PD. For instance, clarify if the 6-week clock resets from the date of the unscheduled (non-PD) scan, or if sites should adhere to the original timeline based on the prior *planned* scan. A preferred approach for consistency would be to reset the 6-week (± 7 days) window from the date of any unscheduled scan that does not confirm PD. Rationale: Clear instructions on scan scheduling after unscheduled assessments will ensure uniformity in efficacy data collection, reduce the risk of protocol deviations related to assessment timing, and improve the consistency of Progression-Free Survival (PFS) data interpretation.