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Improving Clinical Trial Patient’s ...

04/09/2024

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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.

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FDA Issues Updated Draft Guidance on Use of ...

04/02/2024

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The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006.  The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.

Amanda Dzengeleski
FDA Issues Warning Letter for Clinical ...

01/03/2024

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On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.

Amanda Dzengeleski
FDA Releases New Draft Guidance on Confirmatory ...

09/27/2023

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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.

Jennifer Lawyer
FDA Releases 3 New Draft Guidances Regarding ...

09/13/2023

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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.

ISO 14155

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

02/02/2021

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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.

Join the Live Webinar on September 17th! The New ISO 14155:2020 Is Finally Here!

9/13/2020

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When: September 17, 2020

Time: Live from 1-2 PM EDT

Register: HERE

Released in July 2020, ISO 14155:2020 is the third version of the standards that provides direction on how to implement GCP for medical device clinical investigations. The changes in this revision are designed to ensure that ISO standards are up to date with regulatory changes in the industry.

Newly Released! Medical Device GCP International Standard ISO 14155:2020

8/04/2020

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The International Organization for Standardization (ISO) is a network of national standard bodies that develop voluntary standards, some which are applicable to clinical research. Some countries or organizations adopt ISO standards as requirements. ISO standards are reviewed every five years, and it takes approximately three years to develop a new standard.

One important standard in global clinical research is ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice. ISO 14155 has been updated to the third edition and released in July 2020.

Changes to ISO 14155 Medical Device GCP

4/16/2019

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The International Organization for Standardization (ISO) is a network of national standard bodies that develop voluntary standards, some which are applicable in the clinical research field. Some countries or organizations adopt ISO standards as requirements. ISO standards are reviewed every five years, and it takes approximately three years to develop a new standard.

One important standard in clinical research is ISO 14155.