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Now Available: Clinical Pathways’ Major Changes ...

05/30/2025

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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.

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FDA Draft Guidance on Considerations for AI Use

05/21/2025

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In January 2025, the US Food and Drug Administration (FDA) published a draft guidance titled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products” for trial sponsors and stakeholders intending to use AI to generate data and clinical evidence.

FDA Draft Guidance on Considerations for AI Use
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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).

ICH E6 (R2)

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

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

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.

Updated EMA GCP FAQ Guidance: Medical Records Inspection

6/22/2021

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The European Medicines Agency (EMA) Good Clinical Practice Frequently Asked Questions (FAQ) webpage offers guidance on GCP and is updated regularly as additional questions are received. A recently added question with answer regards the inspection of study participants’ medical records by regulatory authorities in the EU.

Question 15: “Do GCP inspectors from regulatory authorities of an EU/EEA Member State have the authority to inspect trial participants’ medical records and other data, even if there is no statement in the ICF establishing that trial participants consent to the review of their medical records and other personal data by EU inspectors?”

New EMA Guidance: Quality Management of Electronic Systems

9/08/2020

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On April 7, 2020, the European Medicines Agency (EMA) released a Notice to sponsors on validation and qualification of computerized systems used in clinical trials. This guidance is applicable for clinical trials conducted in the EU and clarifies that even though a sponsor may delegate all or part of clinical trial activities out to a company, the ultimate responsibility for validation of software tools or electronic systems remains with the sponsor. This guidance also clarifies that most vendors focus on system security of the participant’s personal data, but they lack a focus on how an electronic system used in a clinical trial must comply with Good Clinical Practice (GCP) and the documentation principles of ALCOA+.

Live Webinar Risk Mitigation Changes with ICH E6(R3) and E8(R1) August 25th

8/18/2020

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Change is coming again. Expected updates to ICH GCP E6(R2) and ICH E8 support the agility and adaptability we need to reach the levels of study design, management, and conduct closest to the data and subjects. Taking these theoretical concepts into flexible, reliable, and accountable practices is the next step in more effective trials.

How Can We Work Together to Monitor Quality Source Data Amid COVID-19 Restrictions? Webinar

3/19/2020

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In the rapidly changing environment of COVID-19 restrictions, how can monitors and investigators ensure subjects and their personal health information remain protected and data remains high-quality? The ongoing challenge of site closures, travel restrictions, and social distancing has many unsure of how to proceed.

The Food and Drug Administration (FDA) released a finalized guidance document for conducting clinical trials during the COVID-19 pandemic. It clarifies…