The eClinical Forum offers 2 system assessment forms for investigator sites, sponsors, CROs, and regulators to use free of charge, to evaluate the suitability of an investigator site system to provide data/records for clinical trials. They are:

  • e-Source-Readiness Assessment (eSRA)
  • e-Investigator Site File System Assessment (ISF Assessment)

The 2 system assessment forms contain questions based on regulations and guidelines from global regulatory agencies for clinical research.  Since 2016, eSRA has been globally in use and regulators have accepted its inclusion in study materials. In 2024, the The ISF Assessment, based on eSRA, was released on the request of our eSRA users.  The eCF intends to publish an update to these materials annually, in Q1, to keep current with regulations and guidelines.

  • Each assessment form is packaged in a handbook providing guidance to sites on how to complete the form. The form should not be separated from the handbook, except after completion. 
  • The document “Implementing eSRA – Sponsor Assessment”, while written for eSRA, applies equally to implementing the ISF Assessment.
  • A joint document, “Regulatory documents used as a basis for the eClinical Forum eSRA and ISF Assessments” shows the correlation between these 2 assessment tools and the underlying regulatory documents.

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum in 2024. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the Handbooks and “Implementing eSRA” Guide. We welcome our assessment forms to be used in other formats, however, it is required that all question text be used exactly, that all questions are included, that your use is updated when the eCF forms are updated (annually, Q1), and that eClinical Forum is notified in writing and credited. By using these materials, you acknowledge the terms and conditions for use.  The eClinical Forum is only responsible for materials as distributed via the eClinical Forum website. If using the eCF form, downloaded from this website in its original format, there is no need to notify eCF.

 

Stay Current!!

As new regulations are released or updated, the eClinical Forum will evaluate if the site system assessment form questions should be updated. To be notified of future releases of eSRA and ISF Assessment and/or to provide feedback to the team, please send an email to eSRA@eClinicalForum.org or  ISFA@eClinicalForum.org.  Your email address will not be used for purposes other than to inform you of updates to eSRA and ISF Assessment.

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

We have frequently been asked if we can provide a list of which sites have already completed an eSRA. Due to privacy laws in different countries, eClinical Forum does not keep such a list. We supply the site system assessment questionnaires (eSRA and ISF Assessment), free of charge, to anyone who wants to use it. 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 eSRA or ISF Assessment 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 Views & News

Published on 02 July 2024

eCF Views & News

August 2024

eCF Views:

Some new online discussions … Please join the conversation! (and check out some older discussions or add a new thread of your own…)

  •         How to store/archive electrically signed Informed Consent Forms (with qualified electronic signatures)
  •        New data types in clinical research (audios, videos, photos) – how to de-identify

Please login to the  Discussion Forums (eclinicalforum.org) to respond or to read the full discussion … (You will need a member account to login … but it’s easy to get one .. just register via  Home (eclinicalforum.org) … it can take up to 2 business days for your account to be confirmed.)

  eCF News:

  • Congratulations to the eCF REG team for releasing their 2024 members-only version of the “Requirements for electronic data for regulated clinical trials” (otherwise known as the “eCF Requirements”). This was sent via email to eCF members whose 2024 membership fees are paid or processing. Members who did not receive and would like a copy, please send a note to REG@eclinicalforum.org
  • The REG team has an internal database where they keep all the mappings from the regulatory authority documents to the eCF Requirements. It has some handy reports that the REG team uses and they think some of these might be useful to the eCF members. We have put 4 of them into the Members Repository on our website (new un/pw to sign in). They are: ECF Reqs mapped to EMA Computerised Systems Guide; Regulation Texts from EMA Computerised Systems Guide to eCF Reqs; eCF Reqs mapped to 21 CFR Part 11; Regulation Texts from 21 CFR Part mapped to eCF Reqs. If you find these useful, please let us know: REG@eClinicalforum.org  We can also produce similar reports to other documents that have been mapped.
  • The REG team also released the eCF Requirements V2023.3 as a Public Release. This is available to non-members. It is a significant release as it is the version that incorporated mappings from the EMA Computerised Systems Guide (effective Sept 2023). This is available via the public side of our website and can be passed to your non-eCF friends and customers: Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) (eclinicalforum.org). REG will present a public webinar on this on Sept 18th (see below).
  • Recording: Protocol Optimization using AI/ML – webinar recording from July 18th session with PwC is available in the members section of our website (login required): Protocol Optimisation using AI ML > Webinar Recordings (eclinicalforum.org)
  • Aug 20th Technology Showcase: “Unlocking Clinical Data from EHRs” will be presented by OpenClinica at UTC 1400 and also recorded. For more information or to register: eCF Technology Showcase Webinar: OpenClinca “Unlocking Clinical Data from EHRs” (eclinicalforum.org) 
  • Sept 18th Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments. This is being offered by our REG team to highlight the eCF Requirements and its associated site assessment tools eSRA and ISF System Assessment.  It will be held twice: Europe/Asia Pacific at UTC 0700, and Americas/Europe at UTC 1600. For more information or to register: eCF Public Webinar Sept 2024 (eclinicalforum.org). eCF webinars are typically only offered to eCF members, however this one is a free public webinar – so please pass the information on!
  • Autumn eCF workshops!  Looking for your participation!!
    • Americas in-person workshop: Kindly hosted by eClinical Solutions on October 22-24 in Mansfield, Massachusetts. For more information and to register: eCF Workshop Mansfield MA Oct 22-24 2024 (eclinicalforum.org). Please note – seating is limited to 35 at this workshop, so please register early. Each member company may register up to 2 participants and additional registrations will be put on a waiting list.
    • Europe hybrid workshop: Kindly hosted by Boehringer-Ingelheim on Oct 14-16 in Ingelheim, Germany. Information and registration will be sent via email and posted to our website soon
    • Japan in-person workshop: This will be in Tokyo at the end of October or beginning of November. Details are being confirmed now and will be announced via email, on our website, and in the next “Views and News”.
    • The Program Committee has decided a “theme”: “How does new/evolving eClinical Technology change the role of … Data Managers, IT Support, ClinOps/Administration, Safety Officers, Statisticians, Supply/Logistics, Medical Writers, Archivists, Auditors/QA, Training Depts, Sites, Patients …  Looking for presenters for these topics at all 3 workshops … please send suggestions to Wolgang, Suzanne or Sean (see contact info below).

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. 

Your eCF facilitators are always interested in what you have to say … Suzanne.Bishop@eClinicalForum.org, Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org . Technical or Administrative inquiries should be directed to Adam.Perkins@eClinicalForum.org.

 

 

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Author: Suzanne Bishop (Americas Administrator)

Categories: PRIVACY, Visible by Public

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