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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

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Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

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Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

In November 17, 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released E6 R2 which tries to address some of major developments in technology, medical breakthroughs and business processes – taking into account unprecedented yet justified expectations by regulators, patients, investigators and caregivers.

The eCF webinar explored what was removed and discussed some of the opportunities and challenges presented by additions to the E6 text:

  • How to eliminate sponsor control over Investigator entries/Source data? Where did the contemporaneous investigator copy go and should we forget all about it?
  • How to develop and document risk-based approaches to monitoring in order to protect reliability of trial results (Data Integrity)? How to develop monitoring plans which describe the strategy, methods, responsibilities, and requirements for monitoring the trial?
  • CSV formally makes its way into GCP in a more prescriptive manner than ever before – too late, too little?

Slides used during the event can be downloaded by eCF members from the Members area of the website.

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«April 2018»
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2627
3/27/2018 UTC
53

BoF Webinar: Requirements for Electronic Data for Regulated Clinical Trials (eCF Requirements)

The eClinical Forum is happy to announce the Members-Only release of the “eCF Requirements”, which are based upon statements in regulatory documents 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.  This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.

We will hold 2 webinars to introduce the “eCF Requirements” such that we can accommodate member’s time zones around the globe as well as upcoming national holidays.

Read more
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2345678
9101112131415
1617
4/17/2018 UTC
53

BoF Webinar: Requirements for Electronic Data for Regulated Clinical Trials (eCF Requirements)

The eClinical Forum is happy to announce the Members-Only release of the “eCF Requirements”, which are based upon statements in regulatory documents 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.  This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.

We will hold 2 webinars to introduce the “eCF Requirements” such that we can accommodate member’s time zones around the globe as well as upcoming national holidays.

Read more
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301
5/1/2018 - 5/3/2018 UTC
43

North America Spring Meeting May 1-3 2018 -- Agenda

This meeting is open to industry, healthcare, academic and government partners who are members of the eClinical Forum. Please contact  info@eclinicalforum.org to discuss membership options. Click on title to download Preliminary Agenda.

 

Read more
2
5/1/2018 - 5/3/2018 UTC
43

North America Spring Meeting May 1-3 2018 -- Agenda

This meeting is open to industry, healthcare, academic and government partners who are members of the eClinical Forum. Please contact  info@eclinicalforum.org to discuss membership options. Click on title to download Preliminary Agenda.

 

Read more
3
5/1/2018 - 5/3/2018 UTC
43

North America Spring Meeting May 1-3 2018 -- Agenda

This meeting is open to industry, healthcare, academic and government partners who are members of the eClinical Forum. Please contact  info@eclinicalforum.org to discuss membership options. Click on title to download Preliminary Agenda.

 

Read more
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