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The eSource Readiness Assessment Tool (eSRA) 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 research.

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 in their electronic state for clinical research, but are printed from the electronic health records and then 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.

An eClinical Forum team, comprised of CRAs and Data Managers from different clinical research sponsor organizations and CROs, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized systems ability to be compliant with clinical research regulations. 

                      The eSRA Template Version 2019 can be downloaded as part of the eSRA Handbook below. 

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 Template, 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. 

eSRA Resources

Investigator Site Survey .. Please Participate

Investigator Site Survey .. Please Participate

Partnering for Success

The ongoing Investigator Site Survey survey is open to all site staff involved in clinical trials. By participating in this survey, you will help us to better understand the experience and needs of site staff with clinical trial systems and processes. This is not eSRA -- it is a voluntary survey -- it is not an assessment.  (If you are looking for eSRA, please download the Handbook below).  GO TO THE SURVEY. Expand the article to read more...

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Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

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We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.
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FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016

FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016

Re-Posted from eCF LinkedIn Group

The FDA and OHRP published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent. Expand the article to read more

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EDC Hosting Team Releases Final Documents

EDC Hosting Team Releases Final Documents

Documents Available

The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers. Expand the article to read more and to access the documents.
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Electronic Informed Consent Technology Showcase - An Excellent Event

Electronic Informed Consent Technology Showcase - An Excellent Event

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We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.

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Free access to GCDMP

Free access to GCDMP

Re-Post from eCF LinkedIn

Anyone can now access to this important document for Data Management and Clinical Research.
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