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 V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: ENGLISH Version 2024

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

This 2024 version has updates based on the EMA Guideline on computerised systems and electronic data in clinical trials.

- Sites should complete an eSource-Readiness Assessment (eSRA) to self-assess any site computerized system that could originate or handle electronic data that could become part of a clinical research study to determine it's suitability for this.  The questionnaire is based on regulatory authority expectations.

- Download the Handbook file and save to your computer. The instructions for completing eSRA are in section 3, and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors. One completed assessment can be sent to all of a site's sponsors.

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

Feedback is always welcome (both positive and critical) -- please send to esra@eclinicalforum.org. 

TO DOWNLOAD THE HANDBOOK & SITE FORM (ONE FILE), CLICK ON THE LINK UNDER "DOCUMENTS TO DOWNLOAD" BELOW.

Documents to download

Print
Categories: eSRA
Tags:
Rate this article:
No rating

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)
«March 2024»
MonTueWedThuFriSatSun
26272829123
45678910
11121314151617
18192021
eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

Read more
222324
25262728293031
1234567

Upcoming events Events RSSiCalendar export