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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
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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
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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).

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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
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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

Sponsor-Investigators Frequently Cited in FDA Warning Letters. Do You Know What Is Required for a High Quality Trial?

8/17/2021

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What are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved product. Such trials can help answer important questions about medical products and devices. When investigators initiate the clinical trial, they also must fill the role of a sponsor. A sponsor-investigator conducted clinical trial is also known as an investigator initiated trial. From the regulatory side, there is not a lot of guidance on such trials, but there is a focus on them for inspections. The sponsor-investigator is ultimately responsible for the regulations that are applicable for sponsors AND investigators. Do you know which regulations and guidelines are applicable and that they have different definitions?

DIGR-ACT® Critical Thinking Focuses on Addressing the Right Issue or Risk at the Right Level – Part 3

8/10/2021

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What does ‘G’ stand for?

W. Edwards Deming said, "If you can't describe what you're doing as a process, you don't know what you're doing!" Many people don't naturally think of work as a process but thinking of it that way can help you uncover what might be an earlier cause of something going wrong. Maybe your normal process for grocery shopping is to write a shopping list and take it with you to the grocery store to make sure you get all the items. But today, you get home and realize you are missing several items you needed. As you think through the process steps, you realize you had written on the other side of the list and had forgotten to take a look at the store.

Going step-by-step through the process led you to a possible cause that you could investigate further. This is why ‘Go step-by-step’ is part of the DIGR-ACT® solution - the 3rd step.

Live Webinar: Risk Assessment & CAPA without Tears: The DIGR-ACT® Critical Thinking Solution

8/03/2021

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Date: September 16th OR 23rd, 2021. Choose which date works for you.

Time: 10:30 AM - 12:00 PM EDT

Location: Interactive Webinar

Registration: September 16 Registration HERE September 23 Registration HERE

Cost: AGXPE Member – $79.00

Non-Member Registration – $89.00

Clinical Pathways is pleased to announce a partnership with the Association for GXP Excellence (AGXPE). AGXPE will present the 90-minute interactive webinar hosted by Sam Sather and Keith Dorricott, founders of DIGR-ACT®.

This session will address the challenges in using root cause analysis to lead to effective risk assessment and CAPA for GXP. It will also introduce the challenges and gaps from a process approach standpoint related to integration of essential human performance factors and critical thinking process support. They include highlights of the current significant challenges to performing risk assessment and CAPA without a modern approach to root cause analysis.

These sessions introduce to the GXP audience to DIGR-ACT® as a solution to mature teams and processes in the era of big change.

DIGR-ACT® Critical Thinking Focuses on Addressing the Right Issue or Risk at the Right Level – Part 2

7/27/2021

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You have probably heard of the Five Whys approach to getting to root cause. ‘Why’ is a good question to ask - but not until you've dug around for more information first. After all, you are soon to find additional questions, such as: When did the problem start? - and - Where exactly is the problem? The ‘I’ step in the DIGR-ACT® solution helps through ‘Is - Is Not’ questions. They can help lead you to define the issue better but may also point you in the direction of the root causes.

Clinical Trial Risk & Performance Management vSummit Sept. 28th - 30th

7/20/2021

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What: 4th Annual WCG MCC Clinical Trial Risk & Performance Management Collaborative vSummit

Sponsored by: Metrics Champion Consortium (MCC), a division of WCG

When: September 28th – 30th, 2021

Where: Virtual Summit (vSummit) is online

Register: HERE

Clinical Pathways is presenting and leading discussion groups on two topics:

1) Oversight of Monitoring – Are site issues mitigated? The day in the life of a site QMS and the gap in monitoring.

When: Wednesday, September 29, 2021 from 9:45 AM - 11:15 AM

Facilitators: Charles Sather, BSN, CCRA and Sandra "Sam" Sather, MS, BSN, CCRA, CCRC

2) RBQM Maturity Model – How to manage critical implementation components when they are maturing at a different pace? Small to large sponsor/CRO, implementation adaptability.

When: Thursday, September 30, 2021 from 9:45 AM - 11:15 AM

Facilitator: Sandra "Sam" Sather, MS, BSN, CCRA, CCRC CCRC