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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
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Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting
Applied Clinical Trials has published an article on the eCF eSource-Readiness Assessment (eSRA). eSRA is a list of questions, based on regulation and guidance from FDA, EMA, PMDA, and ICH for Clinical Research sites to self-assess their readiness to provide data from their electronic health records systems. This data may be electronically supplied to sponsors, or manually entered into a sponsor system, however if it originates in a healthcare system, then sponsors are responsible for assessing that these systems are appropriate.
eCF Webinar: Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials
Facilitator:Hugo Cervantes, Vice President Vault CDMS, Veeva
Learn how top pharmaceutical companies and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.
Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)
eCF eSRA Release 2019 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA template questions should be updated.
Click on document title to download.
eSRA (eSource Readiness Assessment) Handbook and Assessment Template
This is the ONE FILE that you need to perform an eSRA EMR/EHR Assessment.
- Sites should complete an eSource-Readiness Assessment (eSRA) to self-assess their healthcare computerized systems (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.
Click on title to get to the download screen.
Announcing Autumn 2019 Meeting Dates
Save the date!!
Oct 14-16 2019 in Peapack, New Jersey USA. Kindly hosted by Pfizer
Oct 28-30 2019 in Zurich, Switzerland EU. Kindly hosted by Business Systems Integration (BSI)
Dec 2-3 2019 in Tokyo, Japan. Kindly hosted by Eli Lilly
North America Autumn Meeting to be hosted by Pfizer in Peapack NJ
The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives and to influence the future. A comment from our Spring 2019 meeting: “Great Forum again! Relevant topics and participants are SMEs or at least willing to share experiences.”
The meeting starts at 1pm on Mon Oct 14 2019 and finishes at 3pm on Wed Oct 16 2019. Each evening there will be networking social events included as part of your meeting registration.
eCF European Autumn Meeting in Zurich Switzerland to be hosted by BSI
Networking with peers has never been more important in order to stay current, collaborate on shared challenges and influence the future. The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives.
This meeting will be of relevance to those with an interest in advancing clinical research from:
Asia Pacific Meeting in Tokyo to be hosted by Eli Lilly
The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives and to influence the future. The following areas will be discussed.