Use of failure mode and effects analysis for risk analysis of investigational drug products management in clinical trials
Through the active participation of IDS pharmacy staff, FMEA successfully identified and prioritized potential failure modes in the IDS pharmacy management process. Corrective actions were proposed to ensure participant safety and continuously improve the quality of clinical trials and IP management.
Authors
- Mingming Song (ORCID: https://orcid.org/0000-0003-2140-9705)
- Bin Zhang (ORCID: https://orcid.org/0000-0003-3516-8105)
- Ying Zhou (ORCID: https://orcid.org/0000-0003-4440-5192)
- Ziwei Wang (ORCID: https://orcid.org/0000-0002-2147-872X)
- Xiaocong Pang (ORCID: https://orcid.org/0000-0002-6891-4701)
Institutions
- Peking University (CN)
- Peking University First Hospital (CN)
Publication Details
- Journal
- American Journal of Health-System Pharmacy
- Published
- 2025-11-07
- DOI
- https://doi.org/10.1093/ajhp/zxaf308
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00