WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

  • 15 June 2017
  • Author: Webmaster
  • Number of views: 13785
  • 0 Comments
ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. The work of the eClinical Forum in the areas of contractual requirements and risk-based software validation was presented…

  • - Industry best practices for contracting of trial-related services within today’s dynamic technology, compliance and stakeholder environment.
  • - Core user requirements for computer system evaluation that is already being leveraged within healthcare and research to provide standardised tools to evaluate risk and to develop risk management and mitigation strategies.

 

 

This work has been extensively referenced and is available for download from the downloads page of the website

Discussion allowed the two sides to better understand requirements, current concerns and potential solutions. Further meetings are planned.

Print
Tags:
Rate this article:
5.0

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«November 2024»
MonTueWedThuFriSatSun
28293031123
45678

Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.

Read more
910
11
eCF APAC Autumn Workshop 2024 Announced

eCF APAC Autumn Workshop 2024 Announced

Registration is open!  Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.

Read more
12
eCF APAC Autumn Workshop 2024 Announced

eCF APAC Autumn Workshop 2024 Announced

Registration is open!  Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.

Read more
1314151617
18192021
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification

eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification

This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions.  The discussion will be around:

  • 100% SDV provides little value for a whole lot of work … but how do we define “critical” data such that not everything is considered critical?
  • How can we implement a risk-based approach without compromising down-stream activities?
Read more
222324
2526272829301
2345
eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

Presenter:        Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)

About this topic:  The final piece of the GCP renovation puzzle, revision 3 of ICH GCP.  Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.

Read more
678

Upcoming events Events RSSiCalendar export