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Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

On 25-Feb-2020, Kelley Olree of Pfizer and eClinical Forum's eSRA Team, presented a very informative and insightful webinar on “Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool”. One participant sent us a note following the webinar "Let me congratulate you for the eSRA Form and the webcast shared yesterday. I’m pretty sure it will become an international standard." 

Kelley has the unique understanding of someone who has worked on clinical trials both from the site side and from the pharmaceutical side. The webinar is one hour long and is full of good information and wisdom. Please click on this link to listen: https://drive.google.com/open?id=1bu_yu-2c45yGiNGtry17QDfSPBFXjtkg

Many have asked for the slides so they are available for download below.

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Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

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