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!
Thoughts on the EMA Guideline on computerised systems and electronic data in clinical trials
2Richards provide thoughts on salient points of the EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials, effective 7 September 2023