Issue

Vol. 1 No. 2 (2024)

Date Log

Submitted
February 19, 2026
Published
December 31, 2024

Copyright (c) 2024 Maha Faheed Alsubaie, Lamyaa ahmed Hamzi, Ibrahim Ali Ibrahim Mashhour, Fatimah Hadi Ahmad Alyami, Maryam Abed Altowirgi, Ali Aletha Beneah Al Harbi, Ahmad Abdulrahman Al Mohaimeed, Dhamah Yahi Hassan Alnamy, Hamad Ali Mohammed AlBugayah Aldosari, Manal Hathal Alqahtani, Ali Mohammed Al-Manjihi, Salihah Qasem Abutaleb Masmali

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Biospecimen Collection and Handling in Clinical Trials: Integrating Nursing, Laboratory, Pharmacy, and Health Security Perspectives

https://doi.org/10.64483/202412656
Maha Faheed Alsubaie
Al-Ahsa Health Cluster, Al-Ahsa City,Ministry of Health, Saudi Arabia
Lamyaa ahmed Hamzi
Jazan-Altuwal General Hospital, Ministry of Health, Saudi Arabia
Ibrahim Ali Ibrahim Mashhour
Jazan-Altuwal General Hospital, Ministry of Health, Saudi Arabia
Fatimah Hadi Ahmad Alyami
Al -Twal Hospital in Jazan, Ministry of Health, Saudi Arabia
Maryam Abed Altowirgi
King Faisal Medical Complex, Altaif, Ministry of Health, Saudi Arabia
Ali Aletha Beneah Al Harbi
ALsalam hospital,Ministry of Health , Saudi Arabia
Ahmad Abdulrahman Al Mohaimeed
Ministry of Health, Riyadh, Saudi Arabia
Dhamah Yahi Hassan Alnamy
Sabya General Hospital, Ministry of Health, Saudi Arabia
Hamad Ali Mohammed AlBugayah Aldosari
Wadi Al dawsir Hospital, Ministry of Health, Saudi Arabia
Manal Hathal Alqahtani
Alimam Abdulrahman Alfaisal Hospital,Ministry of Health , Saudi Arabia
Ali Mohammed Al-Manjihi
Al-Qahmah General Hospital, Aseer Health Cluster,Ministry of Health , Saudi Arabia
Salihah Qasem Abutaleb Masmali
King Fahd Central Hospital in Jazan,Ministry of Health , Saudi Arabia

Corresponding Author(s) : Maha Faheed Alsubaie

Mafealsu@gmail.com

Saudi Journal of Medicine and Public Health, Vol. 1 No. 2 (2024)

Abstract

Background: Biospecimen integrity is fundamental to the validity of clinical trial results, yet the complexity of modern protocols requires seamless multidisciplinary coordination. Pre-analytical variables introduced during collection, processing, and handling can compromise specimen quality and research outcomes. Aim: This narrative review synthesizes evidence-based best practices for biospecimen management in clinical trials, examining the integrated roles of nursing, laboratory personnel, pharmacy, and health security professionals in maintaining specimen integrity. Methods: A comprehensive literature search was conducted across PubMed, Scopus, and clinical research databases for peer-reviewed articles published between 2010 and 2024, supplemented by regulatory guidance documents and industry best practice recommendations. Results: Five key determinants of biospecimen quality are identified: (1) standardized collection protocols with comprehensive training; (2) timely pharmacokinetic sampling with coordination between pharmacy and nursing; (3) laboratory processing factors such as cold ischemia time; (4) proper documentation and temperature-controlled logistics; and (5) adherence to evolving regulatory standards like ICH E6(R3). The BEACH trial illustrates effective multidisciplinary integration through continuous research team availability and structured nursing education. Conclusion: Optimal biospecimen management requires systematic integration of multidisciplinary perspectives from protocol design through sample disposition. Institutions must invest in training infrastructure, technology-enabled tracking systems, and risk-based quality management approaches to ensure research validity and regulatory compliance.

Keywords

biospecimen integrity; clinical trial operations; multidisciplinary coordination; pre-analytical variables; chain of custody
Alsubaie, M. F., Lamyaa ahmed Hamzi, Ibrahim Ali Ibrahim Mashhour, Fatimah Hadi Ahmad Alyami, Maryam Abed Altowirgi, Ali Aletha Beneah Al Harbi, … Salihah Qasem Abutaleb Masmali. (2024). Biospecimen Collection and Handling in Clinical Trials: Integrating Nursing, Laboratory, Pharmacy, and Health Security Perspectives. Saudi Journal of Medicine and Public Health, 1(2), 2358–2368. https://doi.org/10.64483/202412656
Download Citation
Endnote/Zotero/Mendeley (RIS)
BibTeX
References
  1. Ammerlaan, W., Trouet, J., Sachs, M. C., Guan, P., Carithers, L., Lambert, P., ... & Betsou, F. (2018). Small nucleolar RNA score: an assay to detect formalin-overfixed tissue. Biopreservation and Biobanking, 16(6), 467-476. https://doi.org/10.1089/bio.2018.0042
  2. Bai, M., Liu, Y., Qi, M., Roy, N., Shu, C. M., Khan, F., & Zhao, D. (2022). Current status, challenges, and future directions of university laboratory safety in China. Journal of Loss Prevention in the Process Industries, 74, 104671. https://doi.org/10.1016/j.jlp.2021.104671
  3. Booth, B., Stevenson, L., Pillutla, R., Buonarati, M., Beaver, C., Fraier, D., ... & Yan, H. (2019). 2019 white paper on recent issues in bioanalysis: FDA BMV guidance, ICH M10 BMV guideline and regulatory inputs (part 2–recommendations on 2018 FDA BMV guidance, 2019 ICH M10 BMV draft guideline and regulatory Agencies' input on bioanalysis, biomarkers and immunogenicity). Bioanalysis, 11(23), 2099-2132. https://doi.org/10.4155/bio-2019-0270
  4. Botturi, A., Ozbayram, E. G., Tondera, K., Gilbert, N. I., Rouault, P., Caradot, N., ... & Fatone, F. (2021). Combined sewer overflows: A critical review on best practice and innovative solutions to mitigate impacts on environment and human health. Critical Reviews in Environmental Science and Technology, 51(15), 1585-1618. https://doi.org/10.1080/10643389.2020.1757957
  5. Bunce, A. E., Gruß, I., Davis, J. V., Cowburn, S., Cohen, D., Oakley, J., & Gold, R. (2020). Lessons learned about the effective operationalization of champions as an implementation strategy: results from a qualitative process evaluation of a pragmatic trial. Implementation Science, 15(1), 87. https://doi.org/10.1186/s13012-020-01048-1
  6. Cassim, N., Ramdin, N., Moodly, S., & Glencross, D. K. (2022). Cost of running a full-service receiving office at a centralised testing laboratory in South Africa. African Journal of Laboratory Medicine, 11(1), 1504. https://hdl.handle.net/10520/ejc-ajlab_v11_i1_a1504
  7. Chow, F., Lum, S., Ocampo, A., & Vogel, P. (2007). Current challenges for FDA‐regulated bioanalytical laboratories for human (BA/BE) studies, Part II: recent FDA Inspection trends for bioanalytical laboratories using LC/MS/MS methods and FDA Inspection readiness preparation. The Quality Assurance Journal: The Quality Assurance Journal for Pharmaceutical, Health and Environmental Professionals, 11(2), 111-122. https://doi.org/10.1002/qaj.411
  8. Chowdhury, S., Kennedy, J. J., Ivey, R. G., Murillo, O. D., Hosseini, N., Song, X., ... & Paulovich, A. G. (2023). Proteogenomic analysis of chemo-refractory high-grade serous ovarian cancer. Cell, 186(16), 3476-3498. https://doi.org/10.1016/j.cell.2023.07.004
  9. Cornish, N. E., Anderson, N. L., Arambula, D. G., Arduino, M. J., Bryan, A., Burton, N. C., ... & Campbell, S. (2021). Clinical laboratory biosafety gaps: lessons learned from past outbreaks reveal a path to a safer future. Clinical microbiology reviews, 34(3), 10-1128. https://doi.org/10.1128/cmr.00126-18
  10. Di Paolo, S., Nijmeijer, E., Bragonzoni, L., Dingshoff, E., Gokeler, A., & Benjaminse, A. (2023). Comparing lab and field agility kinematics in young talented female football players: Implications for ACL injury prevention. European journal of sport science, 23(5), 859-868. https://doi.org/10.1080/17461391.2022.2064771
  11. Eklund, N., Andrianarisoa, N. H., Van Enckevort, E., Anton, G., Debucquoy, A., Müller, H., ... & Silander, K. (2020). Extending the minimum information about biobank data sharing terminology to describe samples, sample donors, and events. Biopreservation and biobanking, 18(3), 155-164. https://doi.org/10.1089/bio.2019.0129
  12. Franke, A., Blenckner, T., Duarte, C. M., Ott, K., Fleming, L. E., Antia, A., ... & Prigge, E. (2020). Operationalizing ocean health: Toward integrated research on ocean health and recovery to achieve ocean sustainability. One Earth, 2(6), 557-565. https://doi.org/10.1016/j.oneear.2020.05.013
  13. Giavarina, D., & Lippi, G. (2017). Blood venous sample collection: Recommendations overview and a checklist to improve quality. Clinical Biochemistry, 50(10-11), 568-573. https://doi.org/10.1016/j.clinbiochem.2017.02.021
  14. Hill Jr, R. H., & Finster, D. C. (2016). Laboratory safety for chemistry students. John Wiley & Sons.
  15. Hua, L., Yang, Z., & Xiao, C. (2023). MALDI-TOF MS Identification of some Clinically-Relevant Filamentous Fungi with the Direct Smear Method, a Simple Sample Preparation Method. Clinical Laboratory, 69(7). DOI: 10.7754/Clin.Lab.2022.221003
  16. Klingstrom, T., Bongcam-Rudloff, E., & Reichel, J. (2018). Legal & ethical compliance when sharing biospecimen. Briefings in functional genomics, 17(1), 1-7. https://doi.org/10.1093/bfgp/elx008
  17. Koukourikos, K., Tsaloglidou, A., Kourkouta, L., Papathanasiou, I. V., Iliadis, C., Fratzana, A., & Panagiotou, A. (2021). Simulation in clinical nursing education. Acta informatica medica, 29(1), 15. https://doi.org/10.5455/aim.2021.29.15-20
  18. LaRocco, M. T., Franek, J., Leibach, E. K., Weissfeld, A. S., Kraft, C. S., Sautter, R. L., ... & Cornish, N. E. (2016). Effectiveness of preanalytic practices on contamination and diagnostic accuracy of urine cultures: a laboratory medicine best practices systematic review and meta-analysis. Clinical microbiology reviews, 29(1), 105-147. https://doi.org/10.1128/cmr.00030-15
  19. Lemke, M. R., & Broky, D. B. (2020). Chapter 31: Human factors regulations and standards in combination product development: Iec 62366 and fda guidance documents. In Development of Biopharmaceutical Drug-Device Products (pp. 741-766). Cham: Springer International Publishing. https://doi.org/10.1007/978-3-030-31415-6_31
  20. Ménard, A. D., & Trant, J. F. (2020). A review and critique of academic lab safety research. Nature chemistry, 12(1), 17-25. https://doi.org/10.1038/s41557-019-0375-x
  21. Mohs, R. C., & Greig, N. H. (2017). Drug discovery and development: Role of basic biological research. Alzheimer's & Dementia: Translational Research & Clinical Interventions, 3(4), 651-657. https://doi.org/10.1016/j.trci.2017.10.005
  22. Nallathambi, I., Savaram, P., Sengan, S., Alharbi, M., Alshathri, S., Bajaj, M., ... & El-Shafai, W. (2023). Impact of fireworks industry safety measures and prevention management system on human error mitigation using a machine learning approach. Sensors, 23(9), 4365. https://doi.org/10.3390/s23094365
  23. Razmovski-Naumovski, V., West, P. A., Bellemore, F., Byfieldt, N., Bellamy, D., Chye, R., ... & Agar, M. R. (2022). Defining the trials nurses’ role in operationalising a medicinal cannabis clinical trial. Collegian, 29(3), 370-378. https://doi.org/10.1016/j.colegn.2021.10.003
  24. Sanguino, T. M., De Viana, I. F., García, D. L., & Ancos, E. C. (2014). OpenGnSys: A novel system toward centralized deployment and management of computer laboratories. Computers & Education, 75, 30-43. https://doi.org/10.1016/j.compedu.2014.01.011
  25. Santillan, D. A., Jacobus, L. S., Henry, M. D., Weiner, G. J., Winokur, P. L., Knosp, B. M., & Davis, H. A. (2024). Building and implementation of a common infrastructure for specimen and data storage at an academic medical center. NIH Public Access.
  26. Simons, C. C., & Capraro, G. A. (2020). Centralization versus decentralization of clinical microbiology laboratory services: one more choice to make during a global pandemic. Clinical Microbiology Newsletter, 42(23), 187-191. https://doi.org/10.1016/j.clinmicnews.2020.11.001
  27. Snapes, E., Astrin, J. J., Bertheussen Krüger, N., Grossman, G. H., Hendrickson, E., Miller, N., & Seiler, C. (2023). Updating international society for biological and environmental repositories best practices: A new process for relevance in an evolving landscape. Biopreservation and Biobanking, 21(6), 537-546. https://doi.org/10.1089/bio.2023.0140
  28. Sobel, M. E., Dreyfus, J. C., McKillip, K. D., Kolarcik, C., Muller, W. A., Scott, M. J., ... & O'Leary, T. J. (2020). Return of individual research results: a guide for biomedical researchers utilizing human biospecimens. The American journal of pathology, 190(5), 918-933. https://doi.org/10.1016/j.ajpath.2020.01.014
  29. Szapacs, M., Jian, W., Spellman, D., Cunliffe, J., Verburg, E., Kaur, S., ... & Zhou, L. (2023). 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A–Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B-Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine). Bioanalysis, 15(16), 955-1016. https://doi.org/10.4155/bio-2023-0167
  30. Theissinger, K., Fernandes, C., Formenti, G., Bista, I., Berg, P. R., Bleidorn, C., ... & Zammit, G. (2023). How genomics can help biodiversity conservation. Trends in genetics, 39(7), 545-559. https://doi.org/10.1016/j.tig.2023.01.005
  31. Tsibin, A. N., Latypova, M. F., Komarov, A. G., Slutsky, E. A., & Ivanushkina, O. I. (2022). Principles of laboratory service management in modern conditions. Health Сare of the Russian Federation, 66(6), 466-472. https://doi.org/10.47470/0044-197X-2022-66-6-466-472
  32. Wahab, S., Muzammil, K., Nasir, N., Khan, M. S., Ahmad, M. F., Khalid, M., ... & Busayli, A. M. (2022). Advancement and new trends in analysis of pesticide residues in food: A comprehensive review. Plants, 11(9), 1106.https://doi.org/10.3390/plants11091106
  33. Wallert, J., Gustafson, E., Held, C., Madison, G., Norlund, F., von Essen, L., & Olsson, E. M. G. (2018). Predicting adherence to internet-delivered psychotherapy for symptoms of depression and anxiety after myocardial infarction: machine learning insights from the U-CARE heart randomized controlled trial. Journal of medical Internet research, 20(10), e10754. https://doi.org/10.2196/10754
  34. Watson, R. G., Clements-Egan, A., Schantz, A., Ware, M., Wu, B., Yang, T. Y., ... & Marini, J. C. (2017). Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments. Bioanalysis, 9(18), 1407-1422. https://doi.org/10.4155/bio-2017-0044
  35. Wilson, M. L., Fleming, K. A., Kuti, M. A., Looi, L. M., Lago, N., & Ru, K. (2018). Access to pathology and laboratory medicine services: a crucial gap. The Lancet, 391(10133), 1927-1938. https://doi.org/10.1016/S0140-6736(18)30458-6
  36. Wu, A. H., Christenson, R. H., Greene, D. N., Jaffe, A. S., Kavsak, P. A., Ordonez-Llanos, J., & Apple, F. S. (2018). Clinical laboratory practice recommendations for the use of cardiac troponin in acute coronary syndrome: expert opinion from the Academy of the American Association for Clinical Chemistry and the Task Force on Clinical Applications of Cardiac Bio-Markers of the International Federation of Clinical Chemistry and Laboratory Medicine. Clinical chemistry, 64(4), 645-655. https://doi.org/10.1373/clinchem.2017.277186
  37. XIE, J., XIE, L., MA, P., PAN, X., CAO, L., ZHANG, X., & CHEN, Y. (2024). Common problems and suggestions of biological sample management in drug clinical trials. China Pharmacy, 524-528.
Read More
Author biographies is not available.
Download
PDF
Statistic
Read Counter : 53 Download : 176