Safety monitoring
Encyclopedia
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.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event
Adverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
, 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
Contract research organization
A contract research organization, also called a clinical research organization, is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services...
(CRO) staff or contractor, and/or by the Principal clinical investigator
Clinical investigator
A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the...
/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 monitoringClinical monitoringClinical monitoring - Oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials...
- Data Monitoring Committee
- Serious adverse eventSerious adverse eventA serious adverse event in human drug trials are defined as any untowardmedical occurrence that at any dose#results in death,#is life-threatening#requires inpatient hospitalization or prolongation of existing hospitalization...
(SAE) - U.S. Food and Drug Administration (FDA)
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
External links
- ClinicalTrials.gov from US National Library of Medicine
- ICH Website
- FDA Website