Safety monitoring

Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution.

Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract research organization (CRO) staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis. Oversight of the monitoring activity is the responsibility of the sponsor.

See also

• Clinical monitoring
• Data Monitoring Committee
• Serious adverse event (SAE)
• U.S. Food and Drug Administration (FDA)
• European Medicines Agency

References

• Ariel E. Quinio, Safety in Clinical Trials: Who is Responsible? International Biopharmaceutical Association:IBPA Publications, 2005
• Carol Rados, Inside Clinical Trials Testing Medical Products in People FDA Consumer magazine, September–October 2003 Issue

External links

• ClinicalTrials.gov from US National Library of Medicine
• ICH Website
• FDA Website