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  • Tokyo 2-3 December 2019
    Tokyo 2-3 December 2019
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  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
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    Danbury 8-10 April 2019

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eCF North America Autumn Meeting -- Successful Outcome

Oct 2-4 2018 in Philadelphia, hosted by CRF Health

Event date: 10/2/2018 - 10/4/2018 Export event

eCF North America Autumn Meeting -- Successful Outcome

Venue: Wyndham Philadelphia Historic District (near Independence Hall and Liberty Bell) 

Meeting hosted by CRF Health

Please contact info@eclinicalforum.org for more information

Topics for this meeting

Operational

  • PI Signatures – considerations for EDC and non-EDC data
  • Archiving and Decommissioning
  • Audit Trail Reviews
  • eConsent
  • EHR System Assessments for Clinical Research
  • Regulatory topics and current issues

Strategic

  • Trial of the Future Workshop
  • Analytics Insights -- how companies are making sense of the data that they have and using them to make decision
  • Data flow through various systems (EDC, IVRS, eCOA , SAEs etc. and "other data" such as Labs, unstructured data like EHR and longitudinal records from physiological measurement etc. ) for aggregation for decision making and to optimize usability and accessibility by clinical development teams.

New Technologies

  • Digital Biomarkers 
  • AI / Machine learning case study

Evening Networking Events (included as part of the meeting): eCF Members Dinner, Old City Foodie Walking Tour (3-course meal)

 

 

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Birds-of-a-Feather Round Table Discussion:  New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.

The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.

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