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

Assessing Investigator Site File Systems for Clinical Research

By Pablo Perez, Lead Quality Assurance Data Integrity, Astellas

A brief overview of who should use the eCF's newest assessment tool ... and why. This article can be viewed or downloaded by clicking "read more".

"When should audit trail begin?"

eCF published in Applied Clinical Trials 16-June-2021

"When should audit trail begin?"

Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?"  It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

We welcome feedback! Please send to: REG@eclinicalforum.org 

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial

ACT Article on eCF Risk Based Monitoring Approaches and Best Practices

  • 15 December 2015
  • Author: Webmaster1
  • Number of views: 2025
  • 0 Comments
ACT Article on eCF Risk Based Monitoring Approaches and Best Practices

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality. Applied Clinical Trials July/August 2013

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)
«June 2024»
MonTueWedThuFriSatSun
272829303112
345
eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

Read more
6789
10111213141516
17181920212223
242526
eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

Read more
27282930
1234567

Upcoming events Events RSSiCalendar export