Good Clinical Practice Q&A: Focus on Delegation of Authority

摘要

In an informal February 2010 response to this question##the FDA’s Office of Good Clinical Practice responded that##“while the delegation log is a site document recommended in ICH E6##which is official FDA guidance##the delegation log is not required by regulation. FDA does expect personnel delegated study activities to be qualified for the task(s) assigned and overseen by the clinical investigator ... It is therefore prudent to document this information.