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Session 5: Summary Protocol and Results Information: ClinicalTrials.gov & EudraCT
Session Chair(s)
Matthias Zerm, PHD
Lead Expert, Clinical Trial Disclosure and R&D Processes
Germany
Are you prepared to posting results in both registries? How do you ensure consistency across registries considering differences in data fields, process (quality review versus purely automated validation) and timing? This session will address procedural aspects, will give insights around the quality control review at ClinicalTrials.gov and provide an outlook on how information contained in clinical trial registries may become more aligned and more meaningful for patients.
Speaker(s)
Managing Submissions to Global Registries
Thomas Wicks, MBA
Citeline, United States
Head of Transparency Operations
Results Submission “Success”: An Update
Heather Dobbins, PHD
National Institutes of Health (NIH), United States
ClinicalTrials.gov Lead Results Analyst, NCBI/NLM
Improving GSK’s first time acceptance record for Results submissions on ClinicalTrials.gov
Smita Shukla
GSK, United States
Director Clinical Disclosure Reporting
Transcelerate Initiative to Improve Data Quality in Clinical Trial Registries
Munther Baara, MS
EDETEK, Inc. , United States
Vice President, Product Strategy and Innovation