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.

 

NEWS FROM THE ECF

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

  • 15 March 2021
  • Author: Webmaster
  • Number of views: 21709
  • 0 Comments
eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: ENGLISH Version 2021.1 updated on 15-March-2021.

This is the ONE FILE that you need to perform an eSRA Assessment.

- Sites should complete an eSource-Readiness Assessment (eSRA) to self-assess their healthcare computerized systems (e.g. EHR/EMR) for readiness to originate or handle electronic data that could become part of a clinical research study.

- Sponsors/CROs will find useful information in the Handbook in order to evaluate a completed eSRA from a site, to determine if data that originated in the site's healthcare computerized system complies with clinical research regulations

- Download the Handbook file and save to your computer. The instructions are in section 3 and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors.

Note: Version 2021 was released on 15-March-2021. Version 2021.1 and V2021.2 correct minor typos and does not change the content of the questionnaire.

 

Disclaimer:The information presented in these works draws upon the combined understanding and knowledge of the eClinical Forum and is provided as an aid to understanding the environment for electronic clinical research. The opinions of the author(s) and the eClinical Forum do not necessarily reflect the position of individual companies.The content is unconfirmed and users should assess the content and opinions in the light of their own knowledge, needs and experience as well as interpretation of relevant guidance and regulations.

Creative Commons License These works are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License

When you have completed your eSRA ... Please Help! Be a part of the solution -- An easy way for you to participate in the improvement of our e-clinical environment!  We welcome your feedback on the assessment tool. We would also like to use your completed assessment, in an anonymized way, as part of a summary of the ability and needs of site's computerized systems. We are compiling statistics regarding site abilities, to provide information to software vendors and others, regarding areas for improvement. It is our goal that all healthcare systems will become compliant with clinical research regulations and guidances. Please help us -- send your completed assessment to eSRA@eClinicalForum.org   You are welcome to strip off your organization identifying information before sending, however, this is not necessary as we promise to not use this portion of the assessment for our summary purposes. Feedback is always welcome (both positive and critical) -- please send to esra@eclinicalforum.org. 

TO DOWNLOAD THE HANDBOOK, CLICK ON THE TITLE IN "DOCUMENTS TO DOWNLOAD" BELOW.  Instructions for completing an eSRA are in section 3, and eSRA is in section 5.

Documents to download

Print
Tags:
Rate this article:
4.4

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«September 2021»
MonTueWedThuFriSatSun
303112345
6789101112
13141516171819
2021
BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing: “Can we develop best practices for implementing standards across sponsors and CROs of all sizes to drive efficiencies that result in medical advancements getting to patients faster?”

  • Can we facilitate a mechanism to share standards across organizations to avoid process changes from one trial to the next?
  • Can we track standard utilization across organizations to be data driven about when and how updates are needed?
  • With the increase in digital trials, what additional standards should we be considering?
  • What does an optimal standards committee look like? 
Read more
2223242526
27282930123
45678910

Upcoming events Events RSSiCalendar export