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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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eCF Focus Session:  Audit Trail Review in Practice

eCF Focus Session:  Audit Trail Review in Practice

The eClinical Forum published a joint paper with SCDM in April 2021, titled “Audit Trail Review: Key Tool to Ensure Data Integrity”.  (If you missed it, you can download it here: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org) )  Now that members have had time to review the paper and perhaps discuss with colleagues, we thought it is a good time to hear what different members are doing, or are planning to do, regarding audit trail review. This focus session will not be discussing the paper, but rather will be discussing what practices around audit trail review our members are taking.

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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