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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019
We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.
Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".
Birds-of-a-Feather Webinar: Patient Engagement: Techniques, Tools and Technologies
Facilitator: David Stein, D. Bartley Consulting
Opening Statements: Jeff Lee, President, eCOA & Patient Engagement, CRF Bracket and Martin Collyer, “Patient Engagement” Consultant
Duration: one hour (offered at UTC 1300 and UTC 1900) Note: Sydney AU will be at 6am local time on 28-March.
(click on title for more information)
eCF North America Spring Meeting 2019
Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org to suggest topics or get registration information.
eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar
The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.
ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.
To download this file, click on the Downloads tab at the top of this website page.
For more information on the free public webinars, click the title of this article.
BoF Round-Table Discussion Webinar: ePRO Data Changes
Facilitator: Tom Haag, Cardinal Solutions Consulting
The use of ePRO in clinical studies presents an interesting challenge when data recorded by patients and site staff needs to change from initial entry. To the uninitiated, it would be logical to assume that once data is entered, it is never changed. Or at the very least, the data is cumulatively recorded in 21 CRF Part 11-compliant audit trails. This interactive discussion will focus on the data integrity and custody controls required by regulators, for changes that occur more often that we might think.
click on title for more information
AGENDA AVAILABLE: eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019
Our European meeting of the eClinical Forum will take place in Brussels 15-17 May 2019.
Come along and see why our members are so excited... "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions" "People were amazing. Topics were great"
Please register your interest or contact the eCinical Forum for more information.
Expand the article for agenda and further details...
Technology Showcase Webinar: How can a modern CTMS help you to ensure successful trial execution
Succeeding with CTMS – how can a modern CTMS help you to ensure successful trial execution Knowing how and when to use clinical trial management software/systems (CTMS) and how to integrate data from other eclinical systems can help ensure successful trial execution. This tech showcase will highlight what you can expect from a modern CTMS including successful integration ideas and techniques.
Presented by: Jan Klint Nielsen, BSI Business Systems Integration AG
Available to staff from eClinical Forum member companies only. For more information, please contact webmaster3@eclinicalforum.org
Announcing Autumn 2019 Meeting Dates
Save the date!!
Oct 15-17 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)
APAC meeting date will be in November -- to be announced
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