Blog — Clinical Pathways

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

Guidance

FDA Revised Guidance on Remote Monitoring Devices During COVID-19 Restrictions

6/23/2020

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Originally released in March 2020, the Food and Drug Administration (FDA) revised their “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” in June 2020. The guidance is applicable for the duration of the current pandemic. It is intended to further clarify how already marketed non-invasive medical devices may be used with COVID-19 patients to reduce transmission.

NEW UPDATE to Appendix FAQ: FDA’s COVID-19 Clinical Trial Guidance on May 11th

5/12/2020

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As clinical research professionals proceed to work around COVID-19 restrictions while maintaining GCP, questions continue to arise. On May 11th, the Food and Drug Administration (FDA) released an updated Q&A section of their COVID-19 clinical trial guidance with three additional questions and answers included.

Some questions of note from the last two updates are:

Sandra SAM Sather Speaking at ACRP RTP Regional Conference: October 3-4, 2019

9/27/2019

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SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP) Research Triangle Park (RTP) Chapter’s first regional conference. SAM will present on October 4th. Subject matter experts will cover key issues impacting clinical trials, and the conference provides networking opportunities and 12.0 ACRP continuing education credits are available.

Final Device Guidance Released!

9/24/2019

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The U.S. Food and Drug Administration (FDA) released a final guidance, “Humanitarian Device Exemption (HDE) Program.” The guidance is in alignment with requirements from the 21st Century Cures Act and amendments to the Federal Food, Drug, and Cosmetic Act by the FDA Reauthorization Act of 2017 (FDARA).

Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You: January 29, 2019 Webinar

1/4/2019

Topic: Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You

Date: January 29, 2019

Time: 1:00 p.m. – 2:30 p.m. EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.