Safety reporting is the obligatory process of monitoring, recording, evaluating, and communicating (serious) adverse events and reactions that occur during the course of a clinical trial.
Responsibility of investigator
Principal investigator is responsible for the initial assessment and reporting of adverse events to the sponsor, who then further assesses the event, determines causality, and reports to regulatory authorities. Institutional review boards or ethics committees must also be informed about serious adverse events as per local regulations.
Safety reporting requirements
Reporting drug safety information is required to ensure the safety and well-being of study patients. These requirements involve the systematic collection, assessment, and reporting of adverse events (AEs) and adverse drug reactions (ADRs).
Regulatory requirements for safety reporting vary by region. In the United States, the FDA’s regulations for investigational new drug applications (IND) and investigational device exemptions (IDE) outline specific safety reporting requirements. In the European Union, the Clinical Trials Regulation provides comprehensive guidelines for safety reporting.
Typical process of drug safety reporting
The reporting process involves detecting and recognizing an adverse event or reaction, recording detailed information about it, evaluating its severity and potential impact, and promptly reporting it to the sponsor and regulatory authorities.
Immediate reporting is required for life-threatening events or deaths, usually within 24 hours. Serious and unexpected adverse events must be reported within a specific time frame, typically 7-15 days.
Comprehensive safety reports are submitted annually to provide an overview of all adverse events encountered during the trial.
Tools for safety reporting
Tools used in safety reporting include adverse event forms for recording data, electronic systems for tracking and analyzing safety data, and regulatory submissions for compiling and submitting reports to authorities.
See also
Another relevant pages
Links to this page
- Clinical research (← links)
- Interim Clinical Trial (Study) Report (← links)
- Regulatory inspection (← links)
- Serious adverse event (serious adverse drug reaction) (← links)
- Regulation (EU) No 536/2014 (← links)
- Sponsor-investigator (← links)
- Unexpected adverse drug reaction (← links)
- Well-being (← links)
References
External links
- Safety Reporting Requirements for INDs and BA/BE Studies https://www.fda.gov/media/79394/download
- Clinical trials safety initiative https://accelerating-clinical-trials.europa.eu/our-work/clinical-trials-safety_en
- https://english.ccmo.nl/investigators/clinical-trials-with-medicinal-products-ctr/conduct-of-study-ctr/safety-reporting