1/12/18
Date: January 22, 2018
Time: 11:00 am – 12:30 pm EST
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded
Sign up here
-
On September 8th, 2025, the US Food and Drug Administration (FDA) released their final guidance for industry on the ICH E6(R3) Good Clinical Practice (GCP). ICH E6(R3) Principles and Annex 1 were finalized on January 6th, 2025, officially taking over the preceding 2016 ICH E6(R2). Annex 2 is expected to be finalized in early 2026.
-
On December 15th, 2025, the US Food and Drug Administration (FDA) released the finalized guidance for industry “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices”. Unlike most updates, this finalized guidance is replacing the FDA’s recommendations from two separate final guidance documents: “Safety Reporting Requirements for INDs and BA/BE Studies” from 2012 and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” from 2009, both of which are now withdrawn.
-
On July 7, 2025, the European Union (EU) Commission and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published an updated draft of Annex 11: Computerised Systems, a supplementary guideline that is part of the Good Manufacturing Practice (GMP). Although it is GMP focused, the guiding principles of the annex can also be applied to other GxP standards.
-
In July, 2025, the US Food and Drug Administration (FDA) issued a warning letter to an investigator conducting a clinical trial for pediatric participants. The warning letter was the result of a routine inspection part of the FDA’s Bioresearch Monitoring Program (BIMO) as well as the investigator’s written response to the Form FDA 483.
-
On August 27, 2025, the International Organization for Standardization (ISO) released a Draft International Standard (DIS) for the ISO 9001:2026 Quality Management Systems (QMS) to ISO member bodies for a twelve-week review and ballot period. The goal of ISO 9001 is to help organizations create and maintain consistency of their products or services and seeks to improve and refine their internal processes and procedures to increase efficiency.
Date: January 22, 2018
Time: 11:00 am – 12:30 pm EST
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded
Sign up here
The purpose of the Informed Consent Process is to ensure the subject’s understanding of the study prior to enrollment, to protect data integrity and the subject’s safety and rights, and to reduce noncompliance and study drop-outs. Paper consent forms have been used traditionally, but due to more complex clinical trials and longer, more complicated consent forms, they may not be the best option moving forward.
The 2018 edition of the International Compilation of Human Research Standards has been released by the Office for Human Research Protections (OHRP) and can be found here. The Standards compile more than 1,000 laws, regulations, and guidelines from 130 countries, including new countries to the 2018 edition Algeria, Madagascar, Mali, and Saint Lucia. The Standards were created for Sponsors, Investigators, Ethics Committees, and other stakeholders in clinical research, globally. Social-Behavioral research is newly included in the 2018 edition of the Compilation.
TransCelerate Biopharma Inc. has released a set of eConsent Assets as part of its eConsent Initiative.
SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at ACRP: Research Triangle Park Chapter’s 18th Annual Fall Conference on Friday, November 10, 2017.
Topic: “Perspectives in Clinical Research"
When: Thursday, November 9 – Friday, November 10, 2017
Where: North Carolina Biotechnology Center (map)