Data quality in an HIV vaccine efficacy clinical trial in South Africa: through natural disasters and with discipline
Abstract
To produce quality data that informs valid clinical trial results and withstands regulatory inspection, trial sites should adhere to many complex and dynamic requirements. Understanding non-conformance to requirements informs the emerging field of improvement science. We describe protocol deviations in South Africa’s largest HIV vaccine efficacy trial.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Jun 24, 2023
- Source ID
- 10.1186/s12874-023-01967-9
Entities
People
- Fatima Laher
- Kennedy Otwombe
- Mary Allen
- Mookho Malahleha
- Shelly Ramirez
- William Brumskine
- Zoe Moodie
Organizations
- National Institute of Allergy and Infectious Diseases
- National Institutes of Health