Our 2Cents

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!

• Summary of substantive changes in May 11, 2020 update to FDA Guidance on the conduct of clinical trials of medicinal products during COVID 19 public health emergency

• Assessment of EMA Notice to Sponsors on Validation and Qualification of Computerised Systems used in Clinical Trials (7 April, 2020)

• Assessment of EMA Guidance on remote GCP Inspections during the COVID-19 pandemic (18 May, 2020)

• Is your eCRF compliant with the expectations for Investigator sign off in Germany?

• Summary of substantive changes in version 4 of EMA Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic (Feb 2021)

• Assessment of FDA Guidance on Remote Interactive Evaluations during the COVID-19 Public Emergency (April 2021)

• EMA GCP Inspection Reboot post COVID-19 and CTR Implementation