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
Guest User
The Fourth Edition of ISO 14155 Coming Soon

02/04/2025

-

The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO

The Fourth Edition of ISO 14155 Coming Soon
Guest User
New GCP Book Coauthored by Clinical Pathways ...

01/29/2025

-

In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.

New GCP Book Coauthored by Clinical Pathways Now Available
Guest User
New Draft Guidance on Protocol Deviation ...

01/21/2025

-

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New Draft Guidance on Protocol Deviation Management Part 2/2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

01/15/2025

-

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

device studies

Patient-Centric Approach: PRO Used in Medical Device Clinical Trials Guidance

03/08/2022

-

The Food and Drug Administration (FDA) released a guidance “Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Clinical Evaluation” in January 2022. This and a related guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims” from December 2009 are part of an initiative by the Center for Devices and Radiological Health (CDRH) to incorporate the use of patient-reported outcomes (PROs) in evaluating medical devices. The guidance does not replace the Patient-Focused Drug Development (PFDD) guidance series.

ISO 14155:2020 Clinical Leader Article & Medical Device GCP Training

02/02/2021

-

Our article “An ISO 14155:2020 Primer — Good Clinical Practice for Medical Device Trials” was recently published in the Clinical Leader HERE. Following is some background.

The International Organization for Standardization (ISO) is composed of a network of national standard bodies that do not describe country-specific requirements and is the world’s largest developer of voluntary standards. Its goal is for the applicable industries to be more efficient and effective. International standards give specifications for products, services, and good practice. ISO standards help ensure global consistency in a variety of areas and industries, including clinical trials. Although the standards are voluntary, some regulatory authorities or companies require an ISO standard to be followed.