Topics Included: Ensuring Quality
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Our work to improve the quality and efficiency of clinical trials goes beyond the U.S. borders. Recently, CTTI conducted several efforts to help inform the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as it revises ICH E6 Good Clinical Practice (GCP):
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Through a global survey with 327 research professionals from 154 countries, in-depth interviews, and a public open comment period, CTTI issued a report outlining the areas requiring the most focus pertaining to sponsors, essential documents, and investigators.
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CTTI co-hosted a public event with the FDA to help the ICH in its efforts to improve various topics within GCP.
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CTTI also convened two public web conferences hosted by the ICH that provided an update on the progress to revise this important and impactful guideline.
Resources
Ensuring Quality | Expert Meetings
Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
Meeting Overview: The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, is organizing a free two-day Pan-American-focused public web conference on Thursday, June 4, and Friday, June...
Ensuring Quality | Expert Meetings
ICH E6 Guideline for Good Clinical Practice – Update on Progress
MAY 18, 2021 TO MAY 19, 2021 CTTI Project: Informing the Update of ICH E6 On behalf of the International Council for Harmonisation (ICH), the ICH E6 Good Clinical Practice (GCP) Expert...
Ensuring Quality | Webinars
Findings & Reflections from CTTI’s ICH E6 Renovation Work
CTTI Project: Informing ICH E6 Renovation Webinar Presenters: Amy Corneli (Clinical Trials Transformation Initiative) Pamela Gonzalez (Department of Veterans Affairs) Dagmar Gortz (Johnson & Johnson/Janssen) Fergus Sweeney (European Medicines...
Ensuring Quality | CTTI News
Report Now Available: ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress
The report of the public web conference on “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” organized by International Council for Harmonisation (ICH) and convened by...
Ensuring Quality | Resources
Informing the Renovations to the ICH E6 GCP Guideline for Good Clinical Practice Executive Summary
Informing the Renovations to the ICH E6 GCP Guideline for GCP Executive Summary
Ensuring Quality | Publications
Stakeholders’ recommendations for revising Good Clinical Practice
Stakeholders’ recommendations for revising Good Clinical Practice
Regulatory Submissions + Approvals | CTTI News
Recording of Public Web Conference Now Available: Listen to ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress
Recordings for the International Council for Harmonisation’s public web conference, held May 18 & 19, “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” are now available. The...
Regulatory Submissions + Approvals | CTTI News
Report Now Available: Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
The summary report of the web conference on “Stakeholder Engagement on ICH E6 Guidance for Good Clinical Practice,” organized by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical...
Ensuring Quality | Resources
Public Web Conference Report: Stakeholder Engagement on ICH E6 Guideline for GCP
Public Web Conference Report: Stakeholder Engagement on ICH E6 Guideline for GCP
Ensuring Quality | CTTI News
Web Conference Recordings Available: Listen to Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
A recording for FDA and CTTI’s two-day Pan-American web conference held June 4-5, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” is now available. Khair ElZarrad, FDA, and Pamela...
Regulatory Submissions + Approvals | CTTI News
FDA to Organize Two-Day Web Conference with CTTI to Gather Feedback from Stakeholders to Update ICH E6
The International Council for Harmonisation (ICH) is revising ICH E6 Good Clinical Practice (GCP) and requests stakeholder feedback to inform the process. The U.S. Food and Drug Administration, in collaboration...
Regulatory Submissions + Approvals | CTTI News
Webinar Now Available: Findings & Reflections from CTTI’s ICH E6 Renovation Work
A recording is now available of a CTTI webinar on new stakeholder-informed research to identify areas within ICH E6 GCP that are in the greatest need of renovation. The webinar, held Thurs.,...
Ensuring Quality | Resources
Survey Findings: Informing the Renovations to the ICH E6 GCP Guideline
Survey Findings: Informing the Renovations to the ICH E6 GCP Guideline
Ensuring Quality | Resources
Open Comment Findings: Informing the Renovations to the E6 GCP Guideline
Open Comment Findings: Informing the Renovations to the E6 GCP Guideline
Ensuring Quality | Resources
Interview Findings: Informing the Renovations to the ICH E6 GCP Guideline
Interview Findings: Informing the Renovations to the ICH E6 GCP Guideline
Regulatory Submissions + Approvals | CTTI News
Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work
As the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) begins revisions to ICH E6 GCP, new CTTI research highlights opportunities for changes and improvements....