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!
Why Quality Matters
2Richards provide thoughts on why quality matters, and the benefits for quality processes to be embedded into the framework of clinical trials from the earliest stages.
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
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
Expectations for eCRF sign off in Germany
2Richards give a brief assessment of potential impact to Sponsors from the published opinion of the Clinical Trials Expert Group of the ZLG in Germany regarding investigator signatures.