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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.
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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.
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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
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Sponsor, CROs, and research sites are required by regulatory authorities and GCP to have an effective process to manage significant noncompliance through corrective and preventive action (CAPA) plans. These stakeholders should have procedures to support their CAPA system and documentation. Team members must understand the concepts and best practices of a CAPA process and how it should link into quality risk management.
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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.
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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.
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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.
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Topic: Critical Documentation of Clinical Trial Activities and CAPA During and Post COVID-19 Restrictions
When: June 2, 2020
Time: 1:00 p.m. – 2:00 p.m. EDT
Register: By clicking here
