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NEWS FROM THE ECF

eCF Views & News

June 2024

eCF Views & News

eCF Views:

Some recent updates to these discussions on the eCF Members Discussion Forum:

  • Audio recordings – how to make a reliable transcription to meet GCP expectations?
  • Can EDC be used as “source” to capture internally developed ClinRO?
  • How does your company handle user access after study close-out and all subject PDFs are downloaded?
  • We are required to deliver data in dynamic formats, such that data can be sorted, filtered, etc., … so can we stop delivering it also in PDF (which is not required)?
  • A series of questions around the development of the Data Management Plan
  • Your question (please post) … !

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) 2 months ago, and that the tab “eSRA” will be removed from our website around July 1. So, any internal documentation that refers to the tab: eSRA (eclinicalforum.org) needs to be replaced with the new tab link.
  • Japanese translation of eSRA version 2024 is now available! Japanese translation of eSRA V2024 (eclinicalforum.org).  Thank you to Ken Nakano for providing it and for eCF Japanese members who reviewed it.
  • Please check out this article about our newest site assessment form:  Assessing Investigator Site File Systems for Clinical Research (eclinicalforum.org)
  • June 26th webinar:  Dr. Viviënne van de Walle has vast site and patient experience and will share her insight into Site experience in the day-and-age of hybrid e-trials. She presented at our workshop in May and we had many requests for her to present again so everyone can join. Registration link:  eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials (eclinicalforum.org)
  • 2 new eCF Working Groups being considered! 
    • Digital Health Technology and Patient Data Privacy (DHT Data Privacy) – information session for interested eCF members on June 11 at UTC 1300
    • Audit Trail Review Analytics (ATRA) – information session for interested eCF members on June 12 at UTC 1300
    • For more information, please contact Suzanne Bishop
  • Autumn eCF workshops!
    • Americas workshop: Kindly hosted by eClinical Solutions on October 22-24 in Mansfield, Massachusetts. More information will be coming soon!
    • Urgent! Still looking for hosts for the Autumn Europe and Asia workshops… There are many benefits to hosting so this is a win/win! Please contact Wolfgang Summa (Europe) or Sean Higashio (Asia) for more information.
    • 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 webmaster3@eclinicalforum.org. 

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed.

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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.

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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.

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