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New Draft Guidance on Protocol Deviation ...

01/21/2025

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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.

New Draft Guidance on Protocol Deviation Management Part 2/2
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ICH E6(R3) Progresses into Step Four

01/15/2025

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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).

ICH E6(R3) Progresses into Step Four
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New Draft Guidance on Protocol Deviation ...

01/14/2025

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On December 30, 2024, the US Food and Drug Administration (FDA) released the draft guidance for industry titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” to help trial sponsors, investigators, and institutional review boards (IRB) define, identify, and report protocol deviations.

New Draft Guidance on Protocol Deviation Management Part 1/2
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Implementing the New UK Clinical Trials ...

01/07/2025

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The Health Research Authority (HRA) announced that England and Wales have begun implementing changes to their clinical trial regulations on June 1st, 2024. These changes include the removal of the requirement for trials to submit annual progress report to their Research Ethics Committee (REC) and the process of submitting safety reports. Scotland and Northern Ireland, following review, also implemented these changes to their regulations making the updates now applicable in all four of the UK nations as of August 1st, 2024.

Implementing the New UK Clinical Trials Regulations
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ICH E6(R3) Annex 2 Draft Version is Now ...

12/23/2024

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On November 6th, 2024, the International Council of Harmonization (ICH) published the draft version of ICH E6(R3) Annex 2, a long awaited update to the good clinical practice (GCP) section of the ICH Harmonized Guidelines.

ICH E6(R3) Annex 2 Draft Version is Now Available!

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

Device Sponsor Warning Letter: No PMA or IDE

7/13/2021

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A recent US Food and Drug Administration (FDA) warning letter to a device sponsor involves the sponsor marketing a device used for dialysis without an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). The device was previously cleared through the 510(k) pathway. However, the sponsor made significant changes to the design and function of the device.

DIGR-ACT® Critical Thinking Focuses on Addressing the Right Issue or Risk at the Right Level – Part 1

7/06/2021

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DIGR-ACT® is a solution developed by industry experts that addresses the gap of critical thinking skills needed in the era of quality by design and risk management.

What does ‘D’ stand for?

Ever find when your team is trying to fix an issue that matters that you get a long way into the process before realizing each of you has a different idea of what the issue is? That's why we have ‘Define the issue’ as the first step of the unique DIGR-ACT® solution.