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January 24, 2022

Qualifications and Training Documentation

Lack of study team member qualifications and training documentation are the most common findings discovered in SOM clinical studies that are audited/reviewed by UNC’s Clinical Trials Quality Assurance (CTQA) program. In fact, incomplete and/or inaccurate qualifications and documentation of training were identified in 80% of the reviews conducted over the past 5 years. Take a moment to consider how you can ensure you are prepared and meeting the requirements.