Blog — Clinical Pathways

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

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Now Available for Purchase: Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures eLearning

4/20/2021

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Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures interactive eLearning is now available for purchase in our online store HERE.

This interactive eLearning can be used alone or as part of the full curriculum (see more below).

The course provides an overview of the key concepts and best practices for following the U.S. Food and Drug Administration’s (FDA) applicable regulations for financial disclosure, electronic records, and electronic signatures. These topics are applicable to drug, device, and biologic studies. Required by 21 CFR Part 54, sponsors must request certain financial information from clinical investigators, who are performing their studies before a marketing application is submitted. 21 CFR Part 11describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and/or use electronic signatures.

What to Do with Unused IP Shipped to Subjects at Home? UPDATE to FDA’s COVID-19 Clinical Trial Guidance on Dec. 4th

12/17/2020

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The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on what to do with unused investigational product (IP) shipped to study participants’ homes, a more common occurrence during stay at home orders and quarantines during the pandemic. The new question with answer makes it clear that regulations for IP accountability still need to be followed, but that alternative methods to traditional disposition can be considered.

Live Webinar Electronic Systems in Clinical Trials July 30th

7/14/2020

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Join Sandra “SAM” Sather as she presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. It includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials.