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Clinical Research Coordinator Analysis

Participant Burden: Phototoxicity Testing Follow-up

Finding: The requirement for participants to return 18-24 hours after photoprovocation solely for the Minimal Erythema Dose to photoprovocation (MEDp) reading (Protocol Section 7.3.1, page 58) presents a significant logistical challenge for the site and increases participant burden. This necessitates a separate, short-duration visit dedicated only to this reading, which can be difficult to schedule efficiently for both participants (requiring additional travel and time off) and site staff, potentially impacting visit compliance and participant retention. Recommendation: For operational planning, sites should proactively develop scheduling templates that explicitly accommodate this two-part phototoxicity testing procedure, ensuring this is clearly communicated to participants during the informed consent process. We recommend seeking clarification from the Sponsor regarding any allowable flexibility in the 18-24 hour window for the MEDp reading (e.g., can the reading be performed closer to the 18-hour mark or slightly beyond 24 hours if it significantly aids scheduling for the participant, such as early the next morning before work/other commitments?). Additionally, inquire if this brief assessment could potentially be bundled with any other non-fasting, non-procedure-intensive trial activities if a participant happens to be at the site for another reason within an acceptable timeframe, to optimize participant convenience and site resources. Rationale: Proactive scheduling strategies and transparent communication during consenting will enhance participant understanding and adherence to this two-step procedure. Clarification on timing flexibility can reduce scheduling conflicts, improve site operational efficiency by potentially consolidating visits or offering more convenient options, and minimize the risk of missed assessments or protocol deviations related to the MEDp reading visit.