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April 30, 2025
Guest User
EMA on the use of Real-World Data/Evidence in ...

04/30/2025

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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.

EMA on the use of Real-World Data/Evidence in Non-Interventional Studies
April 22, 2025
Guest User
FDA Warning Letter to Sponsor – Records, ...

04/22/2025

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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.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails
April 8, 2025
Guest User
OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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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).

March 24, 2025
Guest User
WMA Adopts 2024 Revision of the Declaration of ...

03/24/2025

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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.

WMA Adopts 2024 Revision of the Declaration of Helsinki
March 10, 2025
Guest User
IRB Warning Letter from BIMO Inspection

03/10/2025

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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.

IRB Warning Letter from BIMO Inspection
Sandra Sather
December 9, 2014

RBM Workshop live: Less than Two Weeks Away!

Sandra Sather
December 9, 2014

12/09/2014

I will be presenting a 1/2 day workshop. Ring in the New Year!

Sandra Sather
December 9, 2014

Just Released: OHRP 2015 Edition of the International Compilation of Human Research Standards

Sandra Sather
December 9, 2014

12/09/2014

The OHRP 2015 edition of the International Compilation of Human Research Standards has just been released. View it here and learn more on what was discussed!

Sandra Sather
November 16, 2014

New Draft Guidance from OHRP: Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care

Sandra Sather
November 16, 2014

11/16/2014

On October 20th, the Office for Human Research Protections’ (OHRP’s) released a new draft guidance which when finalized, will represent their current thinking on this topic.

Sandra Sather
October 13, 2014

Follow-up: Site Solution Summit Master Workshops and Conference

Sandra Sather
October 13, 2014

10/13/14

The Site Solution Summit was another example of great collaborations increasing between Sites, IRBs, Sponsors and CROs!  We are in an exciting era for clinical trials. Like we heard in the FDA presentation, clinical "trails".  

Sandra Sather
September 22, 2014

CRA Oversight

Sandra Sather
September 22, 2014

09/22/2014

Using a “risk-based” approach has paid big dividends in clinical trials, as its principles are applicable to many different functional areas. This is no more visible than when applied to the oversight of Clinical Research Associates (CRA).

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