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3PC-023 New activities within a clinical trial management unit: what new risks for the staff?
  1. A Boutin,
  2. B Petitjean,
  3. F Foursac,
  4. M Antignac,
  5. F Chabonnier Beaupel,
  6. C Metz
  1. Pitié-Salpêtrière, Pharmacy, Paris, France


Background and Importance Pharmaceutical personnel continually face occupational risks (OR) during clinical research, necessitating regular updates to address evolving activities like Advanced Therapy Medicinal Products (ATMPs) and direct patient dispensation.

Aim and Objectives Our goal was to comprehensively assess these risks, utilising a risk mapping approach and implementing tailored preventive measures (PM) for effective mitigation.

Material and Methods In collaboration with pharmacists, managers, and risk assessors, we conducted a thorough risk mapping, evaluating ORs based on severity, frequency, and control mechanisms. Criticality levels were established, leading to categories of very significant, significant, to be monitored, or tolerable risks. Subsequently, PMs were developed, and an action plan was created. Reassessment using the same parameters resulted in residual risk identification, culminating in a comprehensive risk assessment document.

Results Our assessment revealed nine novel ORs in three categories: travel associated with experimental treatment delivery, biological risks linked to ATMPs, and workplace hazards like burns from nitrogen handling. Five were deemed significant, three required monitoring, and one was tolerable. Post-risk mapping, seven PMs were identified, including individual oximeters and respiratory isolation equipment to address hypoxia risk during ATMP handling. Residual risk evaluation indicated three significant risks, five requiring monitoring, and one tolerable, with no risks considered very significant after PM implementation.

Conclusion and Relevance In conclusion, the assessment and targeted implementation of PMs significantly reduced risk criticality within our unit. This approach enhances staff protection during new assignments and activities. Further evaluations will gauge PM effectiveness in maintaining a safe environment for pharmaceutical personnel involved in cutting-edge clinical research and ATMP management.

Conflict of Interest No conflict of interest.

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