10 fundamentals of sample security

The safety and integrity of your research material is of critical importance to your participants, your trial, and your reputation. Most organizations ensure the safety of these invaluable and irreplaceable samples by entrusting them to a specialist partner, but how do you select the best one? Our guide highlights the 10 most important aspects you need to consider when identifying a secure storage supplier.

Clinical trials samples are highly valuable – materially, financially, and intellectually – so their security cannot be compromised. Protecting the integrity and security of your research materials is also crucial in gaining the trust of participants. Assurance that their personal material is safeguarded by sample security leaders could be pivotal in gaining the participants’ consent.

“Research materials must be maintained in a controlled environment and accompanied by a recorded and reportable history. The storage temperature must be regulated and traceable,” [1] says the Global Bioanalysis Consortium Harmonization Team, and samples must be protected by reliable constant monitoring and trusted warning alerts. Your research materials must also be protected from the risks of flooding, fire, and natural disasters.

If you’re considering working with a new supplier to provide secure storage facilities, here are 10 fundamentals you should enquire about:

1. Purpose built
   The demands of modern secure storage require a building that has been constructed to exacting standards. Learn about the history of the building and its construction methods. Ask questions about the local infrastructure, including power supplies. Research its proximity to transport hubs and transport links.
2. Backup equipment
   If your research material is exposed to environments outside of tolerance requirements, it may no longer support your research findings. [2] Emergencies are few and far between, but backup equipment is essential to maintain the integrity of your samples, so check what’s available and included in your package.
3. Emergency power generators
   Your chosen partner should have emergency power generators on standby to provide interruption-free power that ensures your samples remain stored at the optimum temperatures and in the best condition regardless of external factors such as poor weather.
4. High-tech validated monitoring systems
   Having high-tech validated monitoring systems in place that are calibrated to alert those in charge of any potential causes for concern is essential. Once an issue is identified, the storage provider should have clear processes for maintaining the integrity and biological viability of your materials.
5. Fire detection and suppression systems
   Early detection of any risks is crucial, so investigate the fire detection and suppression systems in place at your chosen facility. Check how regularly these are being tested and monitored.
6. Restricted access
   Access to the facility should be closely guarded, with 24/7 restricted access in place. Your storage provider has a duty to regulate access to your samples, providing a comprehensive and detailed record of any visitor who has access to your materials.
7. Security systems
   Learn about the security systems your supplier has in place to monitor the facility, including cameras, motion detection systems, and the physical infrastructure (key cards, code-access, fencing, etc.).
8. Off-site IT support
   The security of your data is as important as your samples. Off-site, cloud-based storage – as a primary method or a back-up – is essential. This can include all records covering access to your materials, ensuring a complete audit trail remains in place.
9. Regulatory insight
   The FDA and other regulators may [3], as part of an audit, request information on the storage and management of all research material. (Find out more about the auditing and quality control process here). Working with an experienced global partner can establish processes that enable you to manage a large inventory as well as navigate the complex challenges of storage and processing across borders.
10. Fully trained personnel
    The best equipment in the world and the best systems in the world are meaningless without trained people in place to monitor and interpret them. Learn about those who will be responsible for protecting your assets, their training and industry experience, and their understanding of the importance of protection.

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References

1. Redrup, M., Igarashi, H., Schaefgen, J., Lin, J., Geisler, L., & Ben M’Barek, M. et al. (2016). Sample Management: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team. The AAPS Journal, 18(2), 290-293. Accessed 11 August 2020 from https://doi.org/10.1208/s12248-016-9869-2
2. Part 8B – Standards for Physical Facilities. DAIDS Guidelines for Good Clinical Laboratory Practice Standards. (2019). Niaid.nih.gov. Retrieved 11 Augusts 2020 from https://www.niaid.nih.gov/sites/default/files/gclp.pdf
3. PART III – INSPECTIONAL. (current as of 2017). Fda.gov. Retrieved 11 August 2020 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/part-iii-inspectional