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A New Data Model to Meet CBER Guidance on Submission of Reactogenicity Data for Vaccine Trials (302377)

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Frances Acton, Merck & Co., Inc. 
Carol Baker, Merck & Co., Inc. 
Karen Conway, Merck & Co., Inc. 
*Qinlei Huang, Merck & Co., Inc. 
Donna Hyatt, Merck & Co., Inc. 
Erin Moeller, Merck & Co., Inc. 
Leslie Morgan, Merck & Co., Inc. 
Heather L Platt, Merck & Co., Inc. 
Pritesh P. Solanki, Merck & Co., Inc. 
Stacey Traina, Merck & Co., Inc. 
Haiping Zhou, Merck & Co., Inc. 

Keywords: Vaccines, OVRR, safety, reactogenicity

The FDA Center for Biologics Evaluation and Research (CBER) published a guidance for industry in April 2018 (with updates in October and December 2019): Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review (OVRR). This guidance will aid clinical and statistical review of vaccine applications by submitting standardized datasets. Merck is designing a new data model to follow CBER’s requirements. This poster presents the next-generation data model with the focus on the submission of reactogenicity data for vaccine trials. Specifically, the poster (1) introduces the key OVRR requirements and the new data models; (2) elaborates the end-to-end process from electronic Vaccination Report Card (eVRC), electronic Case Report Form (eCRF), electronic data capture (EDC) system, to CDISC SDTM and ADaM data; (3) demonstrates the key features and impacts on statistical analysis and report; (4) evaluates the impacts on protocol design, data specifications, data entry guidelines, eVRC screenshot and electronic clinical outcome assessment (eCOA) database standards, data review and reconciliation, medical monitoring, site monitoring, and investigator training; and (5) presents challenges and conclusions.