Skip to main content

March 8, 2022

Identifying Legally Authorized Representatives

The requirement to obtain legally effective informed consent from participants in clinical research is one of the central protections provided under the regulations. When it has been determined that a prospective participant does not have the capacity to provide legally effective informed consent, informed consent must be obtained from a legally authorized representative (LAR). Do you know how to determine who would be considered an acceptable LAR?

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.