10/09/2018
Does familiarity with the paper informed consent process mean that it is the best way? Think that there are no benefits to switching to eConsent? Read about some common myths and follow links to helpful resources.
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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.
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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.
The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have been harmonizing their regulations and guidances to reduce regulatory burden and enhance human subject protections.
Topic: Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 R2 Addendum
Date: October 9, 2018
Time: 1:00 p.m. – 2:30 p.m. EDT
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded (available for 30 days)
Sign-up here
SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP)’s September 17, 2018 event. This in-person event will cover tips for managing trials for sites and sponsors post ICH E6 (R2) addendum, and 1.0 ACRP continuing education credits are available.
Topic: Managing Issues that Matter for Sites and Sponsors/CROs Post-GCP E6 (R2)
When: Monday, September 17, 2018 - 5:30 p.m. – 7:30 p.m. EDT
Where: Mez Contemporary Mexican (map)
5410 Page Rd.
Durham, NC 27703
Hors d’oeuvres and non-alcoholic beverages provided. Cash bar available.
Register: Registration is through ACRP here
Topic: ICH E6 (R2): Impact and Action Planning for Site and Sponsor Teams
When: Thursday, September 26, 2018 - 6:30 p.m. – 8:00 p.m. EDT
Where: Cisco WebEx link provided after registration
Register: EventBrite (link)