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Clinical Research Coordinator Analysis

Skin Biopsy Procedures (Appendix 3)

Finding: The protocol (Appendix 3, page 76) mandates specific and distinct processing for two 4mm punch biopsies taken at Baseline and Week 16 (one placed immediately into RNAlater solution, the second bisected with one half snap-frozen and the other placed in formalin). While the processing steps are outlined, the operational execution presents potential challenges. Specifically, ensuring the consistent availability of all specialized supplies (e.g., RNAlater, cryovials suitable for snap-freezing, appropriate formalin containers, liquid nitrogen/dry ice for snap-freezing) and the precise, time-sensitive coordination required for immediate post-collection processing (especially snap-freezing which requires rapid access to freezing apparatus and a -70/-80°C freezer) can be logistically demanding for busy sites. This complexity is amplified if multiple participants requiring biopsies are scheduled closely, or if dedicated lab personnel are not immediately available to assist clinical staff with these specialized research-only procedures. Recommendation: For sites participating in the optional skin biopsy substudy, we recommend developing a detailed, site-specific Standard Operating Procedure (SOP) or a comprehensive checklist for the entire skin biopsy collection and processing workflow. This document should include:

1. A pre-visit inventory checklist for all required supplies, including lot numbers and expiry dates where applicable, to be completed 24-48 hours before the scheduled biopsy.

2. A step-by-step procedural guide detailing roles and responsibilities from patient preparation, biopsy collection by the qualified investigator, immediate sample handling and division, to processing into each specified medium (RNAlater, snap-freezing, formalin), including labeling and temporary storage requirements prior to shipment.

3. Confirmation of training and delegation for all staff involved in any part of the biopsy procedure.

4. Contingency plans for potential issues (e.g., equipment malfunction like freezer issues, unexpected delays, unavailability of specific supplies).

Regular "Biopsy Kit and Readiness" checks should be integrated into the pre-visit planning for any participant scheduled for these procedures.

Rationale: Implementing a site-specific SOP/checklist will proactively address potential logistical bottlenecks, enhance procedural consistency across staff and visits, minimize the risk of sample degradation or loss due to improper or delayed handling, reduce the likelihood of protocol deviations related to sample integrity, and ultimately ensure the collection of high-quality biological samples critical for achieving the substudy's objectives.