One goal of Trial-CARE is to support investigators and study teams so they are best equipped to implement complex clinical trials in an efficient, cost-effective manner that meets target enrollment goals and high levels of data quality. To that end, we are creating a number of guidance documents on key areas of clinical trial conduct. Please check back here frequently, as we intend to add to this collection over time.
Trial-CARE Guidance Documents:
Part 11 Guidance and Support Resources:
Trial-CARE Intro to Part 11 PowerPoint:
Trial-CARE Part 11 Guidance Documents:
WU Enterprise-Level Part 11 Support Documentation: