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eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH)

Wed, 14-July-2021

Event date: 7/14/2021 Export event

eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH)

eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH)  -- Use of Real World Data in Clinical Research

Date:  14-July-2021      Duration: One hour

Presenter:   Mitra Rocca, Senior Medical Informatician, FDA CDER Health Information Technology Lead

                    FDA, CDER, Office of Translational Sciences

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.

For This Topic:  In this webinar, two of CDER-led RWD projects will be presented:

1.The OneSource Project is a collaboration between investigators at the University of California San Francisco (UCSF) and the FDA with the goal of developing methods to automate the flow of structured Electronic Health Record (EHR) data into clinical trial electronic data capture (EDC) systems thereby reducing operating costs, saving time, and improving data quality for clinical trials.

2. The Common Data Model Harmonization (CDMH) project is led by FDA CDER in collaboration with NIH.  The goal of this project is to harmonize several common data models (CDMs) to generate evidence.   In this webinar the CDMH accomplishments in phase I and ongoing activities for phase II will be presented. 

Time:  UTC 14:00 (California 7am / NYC 10am / London 2pm / Brussels 3pm / India 7:30pm / Singapore 10pm / Japan 11pm)

eCF Members should use this link to register:   Webinar Registration (eclinicalforum.org)

If you are not an eCF member, please review the membership tab on this website for information on becoming a member.

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«August 2021»
eCF Focus Session:  Audit Trail Review in Practice

eCF Focus Session:  Audit Trail Review in Practice

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This is a two-hour focus session. The first hour will be presentations of case-studies from eClinical Forum members. The second hour will be a round-table discussion.

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