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
Guest User
New Draft Guidance on Protocol Deviation ...

01/14/2025

-

On December 30, 2024, the US Food and Drug Administration (FDA) released the draft guidance for industry titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” to help trial sponsors, investigators, and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New Draft Guidance on Protocol Deviation Management Part 1/2
Guest User
Implementing the New UK Clinical Trials ...

01/07/2025

-

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
Guest User
ICH E6(R3) Annex 2 Draft Version is Now ...

12/23/2024

-

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!
Guest User
FDA Releases Final Guidance Q&A on ...

12/19/2024

-

In October 2024, The Food and Drug Administration (FDA) released a final guidance: “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”. It is intended for sponsors, principal investigators, institutional review boards (IRB), contracted research organizations (CRO) (all of which are considered regulated entities) and other interested clinical trial stakeholders that use electronic records and systems.

FDA Releases Final Guidance Q&A on Electronic Systems, Records, and Signatures

Improving Clinical Trial Patient’s Comprehension of Informed Consent Forms

04/09/2024

-

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.

FDA Issues Updated Draft Guidance on Use of Data Monitoring Committees in Clinical Trials

04/02/2024

-

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.

FDA Issues Warning Letter for Clinical Investigation Violations

01/03/2024

-

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.

FDA Issues Investigator Warning Letter: Enrollment and IP Administration

11/07/2023

-

On August 8, 2023, the U.S. Food and Drug Administration (FDA) issued an investigator Warning Letter to Angela M. Stupi, M.D.. There were multiple deficiencies noted at Dr. Stupi’s clinical site. The site enrolled participants who were ineligible per protocol and did not follow the requirements for administering the investigation product.

FDA Issues Revised Draft Guidance on Formal Meetings Between FDA and Applicants of PDUFA Products

10/24/2023

-

On September 21, 2023, the Food and Drug Administration (FDA) released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” to advise on formal meetings between the agency and sponsors or applicants involved in the development and review of investigational products. The new draft guidance replaces the previous version issued in December 2017.