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| monitoring in clinical trials ： ウィキペディア英語版 |
monitoring in clinical trials
Clinical 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. They want to be certain that safety measures are in place to protect participants.
== Functions of the clinical monitor - Clinical Research Associate ==
How to monitor a study in the field requires considerable thought. Almost all field monitoring requires regular visits to the site by the clinical research associate throughout the period of the study. On very rare occasions, an extremely simple, low risk study might be monitored almost exclusively by telephone except for the startup and closeout visits.
A clinical research associate (CRA) must determine how to integrate telephone, email, fax and regular mail communications into a monitoring strategy. This will differ among programs and sites depending on available technology, sponsor and site Standard Operating Procedures (SOPs) and personal preference. In monitoring, like any business, many problems can be traced back to a lack of communication, inappropriate communication and/or unclear communication. A good communication strategy should have a high priority in your monitoring plan.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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