Our Two Cents
We’ve learned a lot over the years, and we love to share our experiences with others. So, we’ve created this page, where we offer our opinions on topics such as informed consent, protocol deviations, clinical trial oversight, and more. When updates to regulations, guidance, or current practices arise, we try to write about these too. We hope that our 2cents will stimulate thought, discussion, and, in some cases, action!
Reflections on FDA’s Informed Consent Guidance
2Richards reflect on the potential impact to Sponsors from the FDA Final Guidance on Informed Consent for Clinical Trials released August 2023