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.

Now Available for Purchase: An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB eLearning

4/06/2021

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Now Available for Purchase: An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB eLearning

An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB interactive eLearning is now available for purchase in our online store HERE. The interactive eLearning course provides an overview of the key concepts and best practices for maintaining human subject protection (HSP) by following the U.S. Food and Drug Administration’s (FDA) applicable regulations. Conduct of a clinical trial involving human subjects includes considerations to protect their rights and safety. Ensuring HSP is a core principle of Good Clinical Practice (GCP) and is required by regulatory authorities. Understanding how to implement these FDA regulations applicable to clinical research is key to a successful and ethical clinical trial.