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 Views & News

July 2024

eCF Views & News

eCF Views:

You can tell it’s summer… nothing much new in the online Forum discussions … but still plenty of old threads worth responding to … or add a question of your own!  Happy Summer for those of you in the Northern Hemisphere!!

Please login to the  Discussion Forums (eclinicalforum.org) to respond or to read the full discussion … (You will need a member account to login … but it’s easy to get one .. just register via  Home (eclinicalforum.org) … it will take up to 2 business days for your account to be confirmed.)

 

 eCF News:

  • eSRA Users! Just a reminder that the eSource-Readiness Assessment (eSRA) information and file downloads were moved to the tab Site Sys Assmts (eclinicalforum.org) 3 months ago, and that the tab “eSRA” will be removed from our website around July 5. So, any internal documentation that refers to the tab: eSRA (eclinicalforum.org) needs to be replaced with the new tab link.
  • June webinar recording available – you want to watch this!  Dr. Viviënne van de Walle, a Principal Investigator with vast site and patient experience shared her insight into Site experience in the day-and-age of hybrid e-trials. The recording is available in the members section of our website (so, login or register for an account). This insight is so valuable – it is worth passing around to anyone in your organization involved in any aspect of site/patient data.  Link: Site experience in the day-and-age of hybrid e-trials > Webinar Recordings (eclinicalforum.org)
  • July 18th webinar on Protocol Optimization using AI/ML will be presented by Ian Shafer of PwC at UTC 1400 and also recorded. For more information or to register: eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML (eclinicalforum.org)
  • Aug 20th Technology Showcase: “Unlocking Clinical Data from EHRs” will be presented by Chris Weiss and Cal Collins of OpenClinica at UTC 1400 and also recorded. For more information or to register: eCF Technology Showcase Webinar: OpenClinca “Unlocking Clinical Data from EHRs” (eclinicalforum.org)
  • 2 new eCF Working Groups being started!
    • Digital Health Technology and Patient Data Privacy (DHT Data Privacy)
    • Audit Trail Review Analytics (ATRA)
    • It’s not too late to get involved … for more information, please contact Suzanne Bishop
  • Autumn eCF workshops!  Looking for your participation!!
    • Americas in-person workshop: Kindly hosted by eClinical Solutions on October 22-24 in Mansfield, Massachusetts. For more information: eCF Workshop Mansfield MA Oct 22-24 2024 (eclinicalforum.org)
    • Europe hybrid workshop: still looking for a host … please volunteer! It is win/win … we come to you!!  Contact Wolfgang Summa
    • Japan in-person workshop: still looking for a host … please volunteer! It is win/win … we come to you!!  Contact Sean Higashio
    • The Program Committee has decided a “theme”: “How does new/evolving eClinical Technology change the role of … Data Managers, IT Support, ClinOps/Administration, Safety Officers, Statisticians, Supply/Logistics, Medical Writers, Archivists, Auditors/QA, Training Depts, Sites, Patients …  Looking for presenters for these topics … please send suggestions to Wolgang, Suzanne or Sean (see contact info below).
  • Members of the eCF Essential Metadata team met with the EMA Investigators’ Working Group in Copenhagen on June 25, 26. The outcomes of this meeting will be discussed at the upcoming eCF workshops. Congratulations to the Essential Metadata team for a job well done.

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. Please feel free to forward this email to your colleagues.

Your eCF facilitators are always interested in what you have to say … Suzanne.Bishop@eClinicalForum.org, Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org . Technical or Administrative inquiries should be directed to Adam.Perkins@eClinicalForum.org.

 

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)
«July 2024»
MonTueWedThuFriSatSun
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
12
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
345
2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The "eCF Requirements" Members Release V2024 has been released.  This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for  electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.

Read more
67
891011121314
15
Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

Read more
161718
eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

We will be discussing the transformative potential of Artificial Intelligence (AI) and Generative AI in clinical development.

Read more
192021
22232425262728
2930311234

Upcoming events Events RSSiCalendar export