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.
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 firstname.lastname@example.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.