Blog — Clinical Pathways

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guidance

Digital Health Information: Applicable to HIPAA Breach Notification? Policy Statement Clarifies

02/08/2022

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Recently, many guidance documents and draft guidance documents regarding digital health information have been released. This is in response to the increase in numbers of devices used in the course of a clinical trial, including wearable devices, ePRO, eCOA, software such as apps, home monitors, etc. These devices collect health information and store or transmit it outside of the collection site. Such vendors need to be aware of how they are classified to ensure compliance with applicable regulations. If they are not directly considered a medical device, the device manufacturers and app developers may be considered vendors of personal health records (PHR) and would then need to comply with the Federal Trade Commission’s (FTC) Breach Notification Rule. The FTC released a Policy Statement to clarify the scope of this Rule.

Comment Now! Draft Guidance: Using RWE to Support Clinical Trials and Observational Studies

12/14/2021

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The US Food and Drug Administration (FDA) released a draft guidance “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products” for public comment in December 2021. This draft guidance is published as part of a series of real-world evidence (RWE) guidance in line with the 21st Century Cures Act (Cures Act). Part of the Cures Act is related to the use of real-world evidence (RWE) to help support regulatory decision making, including the approval of a new indication for an approved drug or to support post approval study requirements. This draft guidance discusses its applicability in using RWE in clinical trials and observational studies.

FDA Issues Draft Guidance on Signature Waiver for Form FDA 1572

6/08/2021

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The US Food and Drug Administration (FDA) issued a draft information sheet guidance “Frequently Asked Questions Statement of Investigator (Form FDA 1572)” as an update to the same titled guidance document from 2010. It provides clarification on when a waiver can be requested when an investigator outside the US cannot or will not sign a Form 1572. The purpose of the Form FDA 1572 is to collect applicable information from the investigators and sub-investigators at clinical research sites to verify they have the appropriate experience and background to conduct the clinical trial. Signing the 1572 is an agreement to conduct the clinical trial according to the applicable FDA regulations while protecting the safety and rights of the study participants and the quality of the data.

Overinterpretation of Safety Reporting Regulations Leads to Burdens at Sites, FDA

4/27/2021

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There has been an increase in the complexity of clinical trials over the last decade. Add to that the support for including more diverse populations who may have additional underlying conditions (FDA Guidance document “Enhancing the Diversity of Clinical Trial Populations”), and this leads to an increase in the number of safety events reported.

Privacy Update: FDA Releases Certificates of Confidentiality Guidance

01/26/2021

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The US Food and Drug Administration (FDA) recently released a guidance on Certificates of Confidentiality. The 21st Century Cures Act (Cures Act) amended the privacy protection for study participants’ section relating to Certificates of Confidentiality (CoC). They are now required for any federally funded clinical research that collects or uses identifiable, sensitive personal information, now known as a mandatory CoC. Discretionary CoC may be requested for non-federally funded clinical research, which is the focus of the guidance. The Cures Act also strengthened the protections for CoC by prohibiting disclosure except under specific exceptions.