Quality Assurance (QA) responsibilities for clinical studies with vulnerable populations

SQA 2025 -- Vulnerable populations are groups of people that are at an increased risk and require additional protections when conducting clinical trials. There are many vulnerable groups in the population, but this poster will focus on children, older adults, pregnant women and people with rare diseases. When conducting clinical trials with a vulnerable group, certain considerations need to be taken to protect the subjects’ rights and welfare. As QA auditors, there are certain aspects of a clinical trial using a vulnerable population that should be scrutinized more closely to ensure the subjects are protected and the proper consent is received.