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NEWS FROM THE ECF

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022

Old York Cellars Winery, Ringoes New Jersey USA

Event date: 08/06/2022 - 10/06/2022 Export event

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022

Registration

This meeting is open to organizations that are members of the eClinical Forum. We encourage you and your colleagues to REGISTER NOW for the sessions that you would like to attend via this link: Hybrid Workshop New Jersey June 8-10, 2022 (eclinicalforum.org)  Face-to-face seats are allocated one or two per member company; Virtual seats are unlimited and free for members.

If you are interested in advancing clinical research but are not a member, please contact us to discuss membership options.

Workshop Topics (contact us for a complete agenda) 

DECENTRALISED CLINICAL TRIALS

  • DCT advancement and hybrid trials
  • Operational Challenges in DCTs and Use of Support Technologies
  • Site Perspectives on Clinical Research Technologies
  • Bring Your Own Physician/Investigator
  • Trials At Home

       REAL WORLD EVIDENCE & DIGITAL HEALTH TECHNOLOGIES

  • Trial Tokenization:  Bridging Clinical Trial And Real-World Data
  • The status of "eSource" systems
  • Challenges of connecting directly to EHR
  • FDA Guidance on RWE and DHT

OPERATIONAL TOPICS

  • Risk-based Data Cleaning
  • Data Standards for Digital Measures
  • Building the Site eTMF checklist

        INNOVATIONS IN CLINICAL RESEARCH

  • Case Studies in Artificial Intelligence & Machine Learning
  • Medical Chatbots
  • Remote Sampling

Evening events include wine-pairing dinner at Old York Cellars and Historical Walking Tour of New Hope, PA. 

Documents to download

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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.  We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

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