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 "BoF" Round table: "A Chat about eCOA"

Published on 02 June 2025

eCF "BoF" Round table: "A Chat about eCOA"

Wed, 9-July-2025

Event date: 09/07/2025 Export event

Birds-of-a-Feather Round Table Discussion:  “A Chat about eCOA”

Date:  Wed, 9-July-2025     Duration: One hour

Facilitators:    Leigh Bobowski: Pfizer, Director, Group Lead, CDS, Clinical Data and Information Sciences

                          Siva Bala: Pfizer, eCOA Lead (Patient Data Strategies), Clinical Data and Information Sciences

Time – UTC: 1400 (NYC: 10am, Brussels 4pm, Beijing: 10pm) We apologize for the inconvenient time in some time zones. Please feel free to forward this invitation to your colleagues within your organization.

Background: eClinical Forum Birds-of-a-Feather webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic: This session is not intended to provide firm answers to the below questions. It is about exchanging views with other participants and gaining insights into the different challenges and needs. This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. To encourage candid discussion, we will not be recording this session.

Continuing the discussions started at the Spring workshops ... we will be discussing:

 Insights on the standardization of instruments within your organization ...

  • Experiences with implementing eCOA builds in-house

    • Experiences/Challenges with Device provisioning
    • Experiences/Challenges with development of Site portals

  • Experiences with MFA : Any patient feedback on MFA vs simple login (PIN or PWD)

Experiences with implementation of 'Reason Not Performed' (QSREASND) in QS domains as outlined in Section 4.1.2.2 of the "Handling of Missing Data in Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory" and Section 3.1.1.2 of the "Handling of Missing PRO Data Submitting Patient-Reported Outcome Data in Cancer Clinical Trials."

  • How are you capturing QSREASND data? Is this incorporated in the Case Report Form (CRF) or within the electronic Clinical Outcome Assessment (eCOA) platform?
  • Have our vendors been able and willing to add 'Reason Not Performed' (QSREASND) if it wasn't already included in the QS?

  • Any considerations and learnings you can share from your experience with this implementation ?

Open To: Staff from eClinical Forum member companies gratis  (If your organisation is not an eCF member, please review our website Membership for membership information or contact info@eclinicalforum.org )

eCF Members can register here:  eCF BoF Round-Table: "A Chat about eCOA"

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Author: Suzanne Bishop (Americas Administrator)

Categories: EVENTS, Webinar/Telecon, Electronic Data Capture, PRIVACY, Visible by Public

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