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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.
eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: ENGLISH Version 2022.2.
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. Sponsors/CROs should also see the document "Implementing eSRA: Sponsor Perspective" on this webpage.
- 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.
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 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.
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HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022
We are pleased to announce our next Workshops:
- Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies
- Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol-Myers Squibb
- Americas: North Wales, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.
The workshops will be available for face-to-face and remote participation. We will soon be in touch with registration details but in the meantime please save the dates in your calendar.
We are building exciting agendas for the meetings. If you can contribute or have topics to propose, then please get in touch.
Views & News -- August 2022
We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org. Click "Read More" to see this month's "Views & News"!
eClinical Forum APAC Workshop
This meeting is kindly hosted by Bristol Myers Squibb and held in a facility near the Tokyo Station. We are currently accepting suggestions for agenda topics and/or presenters in the areas of Decentralized Clinical Trials, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.
Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality
We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.
eCF Technology Showcase: Clinical ink - "Tying Passive Data Collection to Active Mobile Measurements"
This technology showcase will present how to unlock the value of passive data collection in clinical research by tying the rich, voluminous patient data compiled by mobile sensors and wearables to active mobile measurements.
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Uppsala Sweden 4-6 October 2022
We are pleased to announce that registration is now open for our next European Workshop kindly hosted by Viedoc Technologies at their premises in Uppsala, Sweden, on 4-6 October 2022.
This hybrid workshop is available for face-to-face or remote participation. Please note... Not all of the sessions will be available for remote participation. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can
REGISTER HERE
eClinical Forum Americas Workshop
This meeting is kindly hosted by Merck at their Training Facility in North Wales, PA. We are currently accepting suggestions for agenda topics and/or presenters in the areas of Decentralized Clinical Trials, Real World Evidence, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.