Version 2025 has been released!!! This version includes updates based on ICH E6(R3) Good Clinical Practice.    eSRA has been used globally since 2016!!

The eClinical Forum offers 2 absolutely free system assessment forms that consist of regulatory-based questions for evaluating the suitability of an investigator site system to provide data/records for clinical trials.Both forms are part of the eSRA Handbook which provides guidance to sites on how to complete the forms.  We request that Sponsors and CROs do not separate the forms from the handbook. Sites may separate the forms from the handbook after completion such that they are only sharing and storing the completed forms.

  • Form/S for e-Source Systems (e.g. Electronic Health Record Systems (EHRs))
  • Form/F for e-Investigator Site File Systems
  • A Japanese translation of eSRA V2025 is anticipated to be released by the end of June.

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. By using these materials, you acknowledge the terms and conditions for use as described in the eSRA documents.  The eClinical Forum is only responsible for materials as distributed via the eClinical Forum website. If using the eCF forms downloaded from this website in original formats, there is no need to notify eCF.

Stay Current!!

eSRA materials are updated annually and released at the end of Q1. To be notified of future releases and/or to provide feedback to the team, please send an email to eSRA@eClinicalForum.org.  Your email address will not be used for purposes other than to inform you of updates to eCF Site System Assessments.

Do we keep a list of sites that have completed eCF Site Assessments?

Due to privacy laws in different countries, eClinical Forum does not keep such a list. We encourage sponsors to keep a list for themselves of which sites they have received a completed assessment from. We encourage sites to store their completed assessments in a central location (such as their IT department) so that other groups within the same organization / using the same computerised system, can use the previously completed assessment as a starting point.

eCF Site System Assessment Resources – Scroll to see all resources

eCF Americas Autumn Workshop 2024 Announced

Published on 05 June 2024

eCF Americas Autumn Workshop 2024 Announced

October 22-24 2024

Event date: 22/10/2024 - 24/10/2024 Export event

Come join us for discussions on “How new and evolving technology is changing the roles in clinical research” at the eClinical Forum workshop, hosted by eClinical Solutions in Mansfield, MA on October 22-24, 2024. The workshop will provide the usual updates and discussion on the eCF project teams and recent regulatory issues, as well as a day to focus on how the roles of the different participants in the clinical research path (from patient through to regulatory submission) have and will continue to change as technology evolves.

The workshop will be available for in-person participation only. There will be networking/social events on both evenings.  eCF Member companies can register up to 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop will have similar topics and will be live-streamed.  See information on that workshop here: EU Hybrid Workshop Announced (eclinicalforum.org)

2024 Autumn Workshop Topics:

  • Regulatory updates: eCF meeting with EMA IWG
  • eCF Project Team updates and break-out discussions, including Audit Trail Review Analytics, Digital Health Technologies Governance, and Essential Metadata
  • Validation/Continuous Learning in AI products
  • Changing roles in e-clinical for: Patients, Sites, Clin-ops, Safety, Supply/logistics, Data managers, Statisticians, IT Support, Training dept, Auditors/QA, Medical Writing, Archivists.
    • We are looking for people to present their perspective on their changing role -- Please contact us!!

Workshop will take place at:

eClinical Solutions:  603 West St, Mansfield MA 02048

eCF Member companies may register up to 2 seats at this workshop by Oct 1; additional seats can be registered for a waiting list.  For more information or to register: eCF Workshop Mansfield MA Oct 22-24 2024 (eclinicalforum.org)

 

 

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Author: Suzanne Bishop (Americas Administrator)

Categories: EVENTS, North America Meetings

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