The eSOURCE-READINESS ASSESSMENT TOOL (eSRA)

The tool contains questions based on regulations and regulatory agency guidelines for clinical research data sources and should be used to evaluate the suitability of an Investigator Site computerized system to provide data for clinical trials. An eClinical Forum team, comprised of CRAs and Data Managers from different clinical research sponsor organizations and CROs and representatives from sites, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized system's ability to be compliant with clinical research regulations.

Clinical research draws on a combination of data collected during a clinical trial and historical medical information relating to the research subject(s). Many of the data points needed for clinical research are originating in Electronic Health Record Systems, making them "eSource" for clinical research. Even if these data points are not used directly from the site's healthcare system, but are re-entered into a Sponsor's system for a clinical trial, the source of the information (the healthcare system) must still be confirmed as compliant with standards set forth in clinical research regulations and applicable guidance documents.

The eSRA Questionnaire Version 2024 can be downloaded as part of the eSRA Handbook below.  (This version incorporates changes based on the EMA Guideline on computerised systems and electronic data in clinical trials.)

Notice to those intending to include eSRA in their own materials: Copyrighted by the eClinical Forum 2024. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. We welcome eSRA to be used in other formats, however, it is required that eSRA text be used exactly, that all eSRA questions are included, that your use of eSRA is updated when eCF eSRA is updated, 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 the eSRA materials as distributed via the eClinical Forum website. If using the eCF form, downloaded from this website, in it's 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 eSRA questions should be updated. To be notified of future releases of the eSRA Questionnaire, 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 eSRA.

Sponsors & CROS -- Please take our very brief survey regarding how you are using eSRA.  This will help us improve eSRA. Survey link: eCF eSRA Survey (eclinicalforum.org) THANK YOU!!!

Do we keep a list of sites that have completed eSRAs?

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 eSRA questionnaire, 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 eSRA from. We encourage sites to store their completed eSRA in a central location (such as their IT department) so that other groups within the same organization / using the same electronic healthcare system, can use the completed eSRA as a basis to complete their own eSRA.

eSRA RESOURCES – Scroll to see all resources

eCF Views & News

Published on 01 October 2024

eCF Views & News

October 2024

eCF Views:

Some new thoughts posted to our discussion board on these topics (plus, plenty of other discussions…) … 

  • How to store/archive electronically signed ICFs (with qualified electronic signatures)
  • FDA Inspector comments on contents of pdfs (this is a discussion coming out of the eCF REG team)
  • What question are YOU wondering about ... please post your thoughts and get a conversation going!

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:

  • Recording available for our Sept 18th Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments. This was very well attended and appreciated ... registrants were from these 35 countries: Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, China, Check Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Russia , Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Uganda, United Kingdom, United States!!! Thanks to our REG team for hosting it.  The 35-min recording is available on the public side of our website ... so please share with your non-eCF member friends as well as your colleagues!  Recording and slides can be accessed here: Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments (eclinicalforum.org)
  • Autumn eCF workshops!  Last-minute registration is still available!  Each eCF member company are allocated in-person seats that can be used at any of these workshops. Please contact your eCF facilitator (see below) to find out if there are seats available for your organization!
  • 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 contact Suzanne Bishop for more information.
  • Europe hybrid workshop: Kindly hosted by Boehringer-Ingelheim on Oct 15-17 in Ingelheim, Germany. This workshop is available for in-person (the very best way to get in on the discussions and make valuable contacts) as well as for remote viewing via live-stream. In-person seats are allocated as part of your organization’s membership (and there are a few seats still available!), and remote access is unlimited/gratis to anyone in an eCF member company from around the globe. Time to register!! eCF Hybrid Workshop Ingelheim 15-17 October 2024 (eclinicalforum.org).  Please contact Wolfgang Summa for more information.
  • Japan in-person workshop: Kindly hosted by Clario on Nov 11-12 near Tokyo, Japan. For more information and to register: eCF APAC Autumn Workshop 2024 (eclinicalforum.org)  Please contact Sean Higashio for more information.
  •  The new eCF Digital Health Technologies (DHT) Governance team has started! If you are interested in finding out what they are doing and perhaps joining them, please contact Suzanne Bishop for a copy of their charter.
  • The team charters of all of the eCF teams can be viewed in the Members area of our website (you need a un/pw ... see instructions under „Views“ above).  Once in the Members area, look in the Member Document Repository for the folder „eCF Project Team Charters“.
  • Congratulations to the Archiving and Decommissioning team on the endorsement by Arkivum of their 3 papers that were released last year. Arkivum did a review of the 3 papers ("Nature of a Distributed Trial Master File ‐ Practical Aspects"; "The Decommissioning of Computerised Systems Used in Clinical Trials"; "Data Formats Used in Clinical Trials") and provided that in their online blog: Whitepaper: Archiving and Preserving Clinical Trial Data: Reflections on the Joint EUCROF/eCF Task Force whitepapers - Arkivum
  • Coming up in late Nov or early Dec ... date to be determined ... a webinar on the new ICH E6 R3 ... (you will be sent an email with registration information when we are ready!)

 

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Author: Suzanne Bishop (Americas Administrator)

Categories: PRIVACY, Visible by Public

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