Addressing Compliance Gaps with Focused Training Programs
Rather consistently over the years, several general areas have comprised the most usual areas of clinical investigator noncompliance, although there are emerging signs that CDER is finding more cases of significant noncompliance today. It can be argued that these areas of noncompliance can be easily addressed with focused training programs. When the root cause of learning need is clearly identified, a well-designed training solution with relevant case scenarios, practice in building new skills, and measurement of learning outcomes can be quite powerful.