Operationalizing International Regulatory Standards in a Limited-Resource Setting during an Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) Experience

Abstract

International regulatory standards ensure human subjects protection, data quality, and scientific integrity of clinical trials. Operationalizing regulatory standards during a large vaccine clinical trial - the Sierra Leone Trial to Introduce a Vaccine Against Ebola - in a resource-constrained setting during an epidemic required flexibility and creativity. We highlight areas that required special attention, such as developing standard operating procedures appropriate for the setting, obtaining space and supplies for the regulatory office, and creating a strategy to maintain both a dedicated central regulatory office and satellite regulatory sites for this trial with paper-based records.