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In June 2025, The US Food and Drug Administration (FDA) released the final guidance titled; “Conducting Remote Regulatory Assessments Questions and Answers” to facilitate understanding about what a remote regulatory assessment (RRA) is expected from establishments when the FDA initiates or requests an RRA.
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On June 5, 2025, the US Food and Drug Administration (FDA) issued a warning letter and FDA Form 483 to an investigator as a result of objectional conditions observed during a Bioresearch Monitoring Program (BIMO) inspection. According to the letter, the investigator did not adhere to the applicable statutory requirements of Title 21 CFR part 312.60 which states: “An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations”.
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In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.
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In February 2025, the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) released the final guidance “Institutional Review Board (IRB) Written Procedures.”
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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.
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)
The Food and Drug Administration (FDA) published a guidance document on July 18, 2018, entitled “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry,” which finalizes the draft guidance released in May 2016. The purpose of the guidance is to support industry in use of electronic data capture systems (EDC) and electronic health records (EHR) while protecting the confidentiality, integrity, and security of data. The guidance aligns with the 21st Century Cures Act, which prompted the FDA to publish guidance for use of “real-world evidence” in regulatory activities.
CRO Oversight Post ICH GCP E6 (R2) Addendum: July 18, 2018 Course
Date: July 18, 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
Sign up here.
