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Clinical Research Coordinator Analysis

Screening: Menstrual Blood Loss (MBL) Collection Logistics

Finding: The protocol (Inclusion Criterion I3, Section 5.1; Procedure details in Section 7.3.1.1) mandates participant collection of all used sanitary products for 1-2 full menstrual cycles during the up-to-8-week Screening Period for MBL volume assessment via the alkaline hematin method. From a site perspective, this presents a significant operational challenge in terms of ensuring comprehensive and consistent participant training, meticulous management of collection kit supplies, adherence to potentially specific temporary storage conditions for these biological samples prior to shipment, and the coordination of timely, compliant shipments to the designated central laboratory. This is further complicated by inter-participant variability in cycle length, potential for participant collection errors, and the burden of storing/handling such samples at home and then transporting them to the site. Recommendation: For improved operational planning, it is highly recommended that a detailed, site-specific Standard Operating Procedure (SOP) or a comprehensive operational checklist be developed and disseminated to all relevant site staff *before* the first participant is screened. This document should explicitly cover:

1. A standardized script and visual aids (e.g., clear diagrams, FAQs) for CRCs to use when training participants on the correct methods for sanitary product collection, interim storage at home (if any specific requirements like refrigeration are noted in the lab manual), and transport to the clinic.

2. A checklist for assembling MBL collection kits, ensuring all necessary supplies (e.g., pre-labeled collection containers, biohazard bags, absorbent material, participant instructions, return shipping materials if applicable from site to lab, temperature logs if required by the lab manual) are consistently provided and documented.

3. Clear, unambiguous site-level instructions for the temporary storage of collected samples received from participants (e.g., designated, calibrated refrigerator/freezer, temperature logging procedures, maximum allowable storage duration at site) before batching for shipment or individual shipment, as per the central lab manual.

4. A defined workflow for initiating, tracking, and documenting shipments to the central laboratory, including courier scheduling, communication protocols with the lab, and management of shipping supplies.

5. Guidance for CRCs on proactively managing common participant challenges, such as irregular cycles impacting the 1-2 cycle collection window, forgotten collections, incomplete collections, or questions about the process, including predefined triggers for escalating issues to the Principal Investigator or Sponsor/CRO.

Rationale: Implementing a robust, site-level operational plan for the MBL collection process will significantly enhance participant understanding and adherence, reduce the likelihood of pre-analytical errors that could compromise sample integrity and eligibility assessment, streamline site staff workload by providing clear guidance, improve the accuracy and reliability of this key eligibility criterion, and ultimately minimize the risk of screen failures or protocol deviations associated with this complex and demanding screening procedure. This proactive planning contributes directly to data quality and efficient trial execution.