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 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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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).
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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO
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)