Safety Reporting and Pharmacovigilance
Safety reporting and pharmacovigilance are important components of clinical research that aim to identify, evaluate, and prevent adverse events (AEs) and serious adverse events (SAEs) related to the investigational drugs.
The following are some of the key responsibilities related to safety reporting and pharmacovigilance:
- Identification of AEs: AEs and SAEs should be identified and reported promptly by the study personnel, and they should be documented in the CRFs and other study documentation. The definition of AEs and SAEs should be based on the study protocol and the relevant regulations.
- Evaluation of AEs: The AEs and SAEs should be evaluated by the study personnel and the sponsor to determine their causality, severity, and expectedness, and to determine if they are related to the investigational drug.
- Reporting of AEs: The AEs and SAEs should be reported to the sponsor, the IRB/IEC, and the regulatory authorities in a timely manner, as specified in the study protocol and the relevant regulations. The safety reports should be complete, accurate, and consistent, and they should include all relevant information about the AEs and SAEs.
- Tracking of AEs: The AEs and SAEs should be tracked and monitored throughout the study, and the trends and patterns of AEs should be analyzed to identify any potential safety concerns. The AE tracking system should be maintained by the sponsor and the study personnel.
- Safety Data Monitoring: The safety data should be monitored by the sponsor and the safety monitoring committee to ensure the safety of the study subjects and to determine if any interim safety analysis is necessary.
Pharmacovigilance is a continuous process that should occur throughout the life cycle of the investigational drug, from the pre-clinical studies to the post-marketing surveillance. The safety reporting and pharmacovigilance procedures should be performed by trained and qualified personnel, and they should be reviewed and audited regularly to ensure their effectiveness and compliance. The safety reporting and pharmacovigilance procedures are critical to ensure the protection of the study subjects and to support the approval and marketing of the investigational drug.
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