**4.2 Risk management tool**

As part of the quality assurance tools, the processes of prospective sample collection, stabilization and processing, conservation, and distribution in multicenter research studies are managed under a global approach based on risk analysis, aimed at preventing undesired results. Since incidents are treated in the format of corrective and preventative action (CAPA) and root cause analysis (RCA) documentation, these records are used as reference.

So, the implementation by the biobanks of a comprehensive quality control for sample collection kits before shipment to recruitment sites is a result from this risk analysis. The potential consequences (inadequate preservation of samples due to inappropriate devices, containers, or additives, lower amount of derivatives for analysis, or loss of traceability) and costs of this process (new shipment of replacement kits and time of technician dedicated to kit checking), in addition to the number of nonconforming kits detected, have been evaluated. Quality control of kits is performed with a checklist, and follow-up of kit preparation and shipments is made with a specific record. Similarly, a checklist for the recruitment sites is included to track the reception of kits.

In addition, a training activity for the staff from the recruitment sites is organized before initializing the donors' recruitment to present the procedures for sample handling and the kit composition and usage. On the other hand, a pilot in a recruitment site is necessary to validate the model designed and to propose improvement measures.

## **5. Conclusions**

The biobank-supported workflow, specifically designed and implemented for each research study, allows obtaining prospective, harmonized, and quality samples avoiding pre-analytical bias and contributing to the validity of the analytical results. Through biobanking processes and continuous and overlapped checkpoints, quality derivatives are obtained based on common and evidence-based standard operating procedures and supervised materials, with associated traceability information in relation with their collection, processing, conservation, and distribution. The effective workflow established is valid for large and complex multicenter projects.
