Blog — Clinical Pathways

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COVID-19

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.

Electronic Consent Now Available with FDA’s COVID MyStudies Application

6/09/2020

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Although electronic consent is permitted and encouraged by the Food and Drug Administration (FDA), many stakeholders have continued to use paper consents. Investigators have been having difficulties obtaining informed consent from subjects during the COVID-19 restrictions, especially from patients in isolation. The FDA developed the MyStudies application in 2018 as a tool to collect real-world data from subjects. Currently, it is available as the COVID MyStudies app in mobile device app stores for download. The app is intended to provide a reliable and regulatory-compliant way to obtain electronic informed consent.

Another UPDATE to Appendix FAQ: FDA’s COVID-19 Clinical Trial Guidance on June 3rd

6/03/2020

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As clinical trials continue but restrictions remain in place, the Food and Drug Administration (FDA) continues to receive and compile questions about clinical trials conduct. On June 3rd, the FDA released an updated Q&A section of their COVID-19 clinical trial guidance with three additional questions and answers included.

GDPR and Clinical Trials Amid COVID-19

5/26/2020

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The World Health Organization (WHO) is recommending using telehealth during the COVID-19 pandemic. To keep subjects and site personnel safe, many sites have transitioned to using telehealth for study visits. What about safeguarding data and privacy? The General Data Protection Regulation (GDPR) has some stringent rules for collecting or processing data which includes during the conduct of a clinical trial.

OCR Update on HIPAA and COVID-19

5/19/2020

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The HIPAA Privacy Rule is frequently used as the reason for not allowing data to be shared, even when the participant’s HIPAA authorization states allowance of disclosing PHI, including remotely or virtually. The Office for Civil Rights (OCR) released a February Bulletin on HIPAA and COVID-19 to clarify how Protected Health Information (PHI) can be shared while still maintaining privacy during the crisis.