Safety monitoring

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 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.

ee also

*Clinical monitoring
*Data Monitoring Committee
*Serious adverse event (SAE)
*FDA
*European Medicines Agency

References

* Ariel E. Quinio, [http://www.ibpassociation.org/ibpa_unpublished_articles.htm Safety in Clinical Trials: Who is Responsible?] International Biopharmaceutical Association: [http://www.ibpassociation.org IBPA Publications] , 2005
* Carol Rados, [http://www.fda.gov/fdac/features/2003/503_trial.html Inside Clinical Trials Testing Medical Products in People] FDA Consumer magazine, September-October 2003 Issue

External links

* [http://www.clinicaltrials.gov/ ClinicalTrials.gov] from US National Library of Medicine
* [http://www.ich.org ICH Website]
* [http://www.fda.gov/ FDA Website]


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