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Clinical Research Coordinator Analysis

Skin Biopsy Substudy Logistics

Finding: The optional skin biopsy substudy (Section 5.8.1, Appendix 4), requiring two 4mm punch biopsies at Screening (and potentially Day 29/85) with specific processing for distinct analytes (eg, one biopsy into 10% neutral buffered formalin and the other into RNAlater® solution), presents considerable logistical hurdles. These include coordinating proceduralist availability (who may not be the PI), ensuring specialized kit readiness (including different preservation media), managing immediate post-collection multi-step sample processing to prevent degradation, and adhering to strict shipping conditions, all of which can be challenging to execute flawlessly during busy clinic days and may increase the risk of pre-analytical errors. Recommendation: Prior to enrolling any participant into the skin biopsy substudy, sites should develop a detailed site-specific Standard Operating Procedure (SOP) or workflow document. This document should explicitly outline:

1. Clear roles and responsibilities for biopsy scheduling, confirmation of participant eligibility for biopsy on the day, kit management (ordering, receipt, storage, expiry tracking), procedure assistance, precise sample handling and division, preservation steps as per the lab manual, and shipping coordination.

2. A pre-procedure checklist verifying availability and integrity of all necessary supplies (biopsy tools, RNAlater®, formalin, appropriate collection tubes, labels, temperature-controlled shipping materials).

3. A visual, step-by-step guide for sample processing immediately post-collection, emphasizing correct aliquotting and preservation techniques for each biopsy portion.

4. Contingency plans for common issues (e.g., proceduralist delays, kit component issues, unexpected shipping constraints).

A mandatory pre-study (or pre-first-biopsy) dry run or detailed walkthrough involving all relevant site staff (CRC, PI, proceduralist, unblinded pharmacist/staff if involved in kit prep, and any back-up personnel) is highly advised to ensure familiarity and identify any site-specific challenges.

Rationale: Establishing a clear, site-specific workflow, reinforced by a practical walkthrough, will proactively address potential bottlenecks, ensure all staff are aligned on the complex procedures, significantly reduce the risk of sample collection or processing errors, safeguard sample integrity critical for biomarker analysis, and minimize protocol deviations related to the skin biopsy substudy.