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MHRA Updates EHR Remote Access Monitoring Guidance

9/21/2021

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The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) updated their guidance document, “Access to Electronic Health Records (EHR) by Sponsor representatives in clinical trials” in September 2021. Originally released in November 2020, it did not provide adequate guidance on direct remote access of EHR. Other relevant guidance only included small sections on remote monitoring, including the March 2020 guidance describing best practices for managing clinical trials during the COVID-19 pandemic and the November 2020 guidance describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic.

Sponsor-Investigators Frequently Cited in FDA Warning Letters. Do You Know What Is Required for a High Quality Trial?

8/17/2021

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What are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved product. Such trials can help answer important questions about medical products and devices. When investigators initiate the clinical trial, they also must fill the role of a sponsor. A sponsor-investigator conducted clinical trial is also known as an investigator initiated trial. From the regulatory side, there is not a lot of guidance on such trials, but there is a focus on them for inspections. The sponsor-investigator is ultimately responsible for the regulations that are applicable for sponsors AND investigators. Do you know which regulations and guidelines are applicable and that they have different definitions?