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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.
Event date: 5/4/2021 - 5/18/2021 Export event
The Covid-19 pandemic is still affecting life and we hope that you are all keeping safe and well. Unfortuneately, we won’t be in a position to run our normal face-to-face workshops for some time yet, but we will still meet together, albeit virtually.
Today, we are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.
Our virtual workshops in 2020 were a great success and this one will be even better! We are making sure that sessions are as convenient as possible for the different time-zones across the world by limiting the duration of sessions and offering more regional events. Learning from each other is what we do best, and the workshop will provide plenty of opportunity for learning, experience exchange, open discussion and contribution to the work of the eClinical Forum. Nothing will replace the networking and comeraderie of an eCF face-to-face meeting, but we hope to come close!
If you are a member of the eClinical Forum... We encourage you and your colleagues to REGISTER NOW for the sessions that you would like to attend (https://www.eclinicalforum.org/forms/VWMay21 ).
If you are NOT a member of the eClinical Forum ... please CONTACT US to find out about the value of membership.
NOT A MEMBER?
MEMBERS...Recordings Now Available | ICH E6 Guideline for Good Clinical Practice (GPC) – Update on Progress
...public web conference, "ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress," that was held on May 18 & 19 and organized by the International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI).
...listen to the web conference recordings, view the slides of the full presentations, and watch this video about the ICH guideline development process.
To stay up to date on the work to revise ICH E6, please visit the ICH web page.
VISIT THE ECF MEMBER DISCUSSION ON ICH E6 R3
eCF BoF Round-table: Utilization of Scribes for eCOA
This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing “The utilization of scribes is needed for the conduct of clinical assessments within eCOA. Therefore, eCOA needs to be built in a manner that meets the regulatory requirements for scribing, to ensure all individuals participating in the assessment are audit trailed.”
"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.
Link to article: When Should the Audit Trail Begin? (appliedclinicaltrialsonline.com)
We welcome feedback! Please send to: REG@eclinicalforum.org
eCF Webinar: FDA OneSource and Common Data Model Harmonization (CDMH)
eCF Webinar: FDA OneSource and Common Data Model Harmonization (CDMH) - Use of Real World Data in Clinical Research
Presenter: Mitra Rocca, FDA CDER Health Information Technology Technical Lead
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact email@example.com )