Blog — Clinical Pathways

April 8, 2025

Guest User

OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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

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

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.

February 26, 2025

Guest User

FDA Webinar on Improving the Informed Consent ...

02/26/2025

On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.

FDA Webinar on Improving the Informed Consent Process

February 19, 2025

Guest User

FDA BIMO Inspection Results in Warning Letter

02/19/2025

On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).

FDA BIMO Inspection Results in Warning Letter

source documents

Jennifer Lawyer

January 5, 2021

How Do You Monitor Sites that Will Not Upload Source to Secure Repositories While Remote Monitoring? – Part 2

Jennifer Lawyer

January 5, 2021

01/05/2021

With no end to site restrictions in sight, sponsor/CRO monitors continue to look for guidance on best practices and logistics for remote monitoring during the pandemic. Our Clinical Leader article “Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations” has inspired related questions. Here is a sample of a recent one.

Question: Many sites now use eReg vendors such as Veeva, Florence, RealTime, etc. as a source document depository database for monitors to review and leave source questions within. This allows the monitors to conduct the SDV on certified source remotely.

Part 1 of the blog covered important details about sticky notes being used in monitoring. If you missed it, read more HERE.