"This is the best use of my time to remain current with what is going on in the industry."
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.
Version 2022.1JP1 (10-May-2022)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback. With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool. This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.
Background vector created by YusufSangdes - www.freepik.com
We have recently learnt that fraudulent Emails have been sent out with eclinicalforum.org addresses. The security issue has now been fixed, however, please be vigilant if you have received Emails during April and May purportedly from the eClinical Forum if they are asking for payment or personal information.
Please don’t hesitate to contact us at webmaster3@eclinicalforum.org if you have any questions or concerns.
Voluntary Investigator Site Survey survey concluded with 528 responses.
We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.
The eCF is releasing 3 documents via the eCF website “Members” area (un/pw required). Please feel free to download them and share with other members of your company.
NOT A MEMBER?
HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022
We are pleased to announce our next Workshops:
- Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies
- Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol-Myers Squibb
- Americas: North Wales, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.
The workshops will be available for face-to-face and remote participation. We will soon be in touch with registration details but in the meantime please save the dates in your calendar.
We are building exciting agendas for the meetings. If you can contribute or have topics to propose, then please get in touch.
Views & News -- August 2022
We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org. Click "Read More" to see this month's "Views & News"!
eClinical Forum APAC Workshop
This meeting is kindly hosted by Bristol Myers Squibb and held in a facility near the Tokyo Station. We are currently accepting suggestions for agenda topics and/or presenters in the areas of Decentralized Clinical Trials, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.
Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality
We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.
eCF Technology Showcase: Clinical ink - "Tying Passive Data Collection to Active Mobile Measurements"
This technology showcase will present how to unlock the value of passive data collection in clinical research by tying the rich, voluminous patient data compiled by mobile sensors and wearables to active mobile measurements.
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Uppsala Sweden 4-6 October 2022
We are pleased to announce that registration is now open for our next European Workshop kindly hosted by Viedoc Technologies at their premises in Uppsala, Sweden, on 4-6 October 2022.
This hybrid workshop is available for face-to-face or remote participation. Please note... Not all of the sessions will be available for remote participation. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can
REGISTER HERE
eClinical Forum Americas Workshop
This meeting is kindly hosted by Merck at their Training Facility in North Wales, PA. We are currently accepting suggestions for agenda topics and/or presenters in the areas of Decentralized Clinical Trials, Real World Evidence, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.