Blog — Clinical Pathways

Now Available! ICH E6(R3) Comparison Tool. Includes Final Principles, Annex 1, and draft Annex 2. Click here to purchase.

FAQ

A Great Resource: The European Medicines Agency’s FAQ Site

10/06/2020

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Have you visited the European Medicines Agency’s (EMA) Frequently Asked Questions (FAQ) page? It is a valuable resource for sponsors and CROs participating in global trials in reference to Good Clinical Practice (GCP) in the context of the 28 countries of the European Union.

On this site, the EMA has published answers to the most frequently asked questions it has received and organized them into 11 categories.

Should We Treat the Safety Review of COVID-19 Study Participants Differently? UPDATE to FDA’s COVID-19 Clinical Trial Guidance on September 21st

9/22/2020

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As sponsor or CRO monitors are continuing to monitor clinical trial sites remotely for the foreseeable future, additional clarification is needed for how to proceed while protecting subject safety and data integrity. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on the requirements for the investigator to review IND safety reports. The question and answer guidance shows how we must be very careful to not decrease the safety protection checks and balances we have in GCP between stakeholders.

Now Available FAQ Document and Recorded Webinar: “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions”

4/07/2020

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Our popular “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions” webinar prompted many important questions, which we answered during the webinars. If you missed the webinar, a recording is now available for purchase. We also compiled a FAQ document to help guide your remote monitoring efforts during the crisis.