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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.
This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021
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.
The EUCROF and eClinical Forum Electronic Informed Consent (eConsent) Joint Task Force are pleased to announce the publication of the eConsent Implementation Guide (version 1). The joint task force was formed in 2019 with a view to look at some of the barriers to adoption of eConsent considering the benefits to stakeholders.
eConsent offers remote electronic options for informing and consenting trial participants of a clinical trial, this being a particularly useful capability especially during the pandemic period when site visits are reduced.
The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”. This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.
ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.
The eClinical Forum is a peer networking group run by its members for its members. Our newsletter provides important information and facts about the eClinical Forum. Read about the philosophy and objectives of the group, the eCF community and the work it has done, the teams that are active and what our members say. There is nothing quite like the eClinical Forum.
The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR” The eClinical Forum has produced a set of 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.
Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations . July 8, 2019
The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) 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
The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.
ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of 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.
The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.
Nearly 200 attendees participated in a webinar delivered by the eClinical Forum for ACRP.
The objective of the webinar was to allow attendees to:
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eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research
A member from each eCF Project Team will present significant items in this guideline, from the perspective of their team topic.
Japanese translation of eSRA V2023
Version 2023.2JP1 (18-Sep-2023)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
Birds-of-a-Feather Presentation and Discussion: Audit Trail Review Tools
The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.
eClinical Forum Hybrid Workshop, Barcelona, Spain
We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems
This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.
We encourage you and your colleagues to REGISTER NOW
Download Agenda HERE
Americas Autumn Workshop
eClinical Forum Autumn Workshop, Spring House, Pennsylvania
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Janssen in Spring House, Pennsylvania on October 24-26 2023.
This is an in-person workshop. There will be networking/social events on both evenings. Each eCF Member company in the Americas region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded. Information on the European workshop will be on our website soon.
eClinical Forum Autumn Workshop, Kobe, Japan
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Kobe, Japan on November 13-14 2023.
This is an in-person workshop. There will be networking/social events on the first evenings. Each eCF Member company in the APAC region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded.
eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Viedoc Technologies, an eClinical Forum member company, will showcase their e-Trial Master File/e-Inestigator Site File solution. The eClinical Forum does not promote nor endorse any particular technology vendors.