Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic

Publication date: Sep 19, 2023

Objectives: To automatically populate the case report forms (CRFs) for an international, pragmatic, multifactorial, response-adaptive, Bayesian COVID-19 platform trial. Methods: The locations of focus included 27 hospitals and 2 large electronic health record (EHR) instances (1 Cerner Millennium and 1 Epic) that are part of the same health system in the United States. This paper describes our efforts to use EHR data to automatically populate four of the trial’s forms: baseline, daily, discharge, and response-adaptive randomization. Results: Between April 2020 and May 2022, 417 patients from the UPMC health system were enrolled in the trial. A MySQL-based extract, transform, and load pipeline automatically populated 499 of 526 CRF variables. The populated forms were statistically and manually reviewed and then reported to the trial’s international data coordinating center. Conclusions: We accomplished automatic population of CRFs in a large platform trial and made recommendations for improving this process for future trials.

Concepts Keywords
Conducting Adaptive
Fda Clinical
Pandemic Covid
Therapy17 Crfs


Type Source Name
disease VO population
disease VO report
disease MESH COVID-19 Pandemic
drug DRUGBANK Corticorelin
disease IDO process
disease VO USA
disease VO protocol
disease VO organ
disease MESH pneumonia
disease IDO intervention
drug DRUGBANK Heparin
drug DRUGBANK Hydrocortisone
disease MESH critically ill
disease VO adverse event
disease MESH bleeding
disease MESH myocardial infarction
disease MESH deep vein thrombosis
disease MESH emergency
drug DRUGBANK Angiotensin II
drug DRUGBANK Lopinavir
drug DRUGBANK Ritonavir
disease VO document
disease VO time
disease VO storage
drug DRUGBANK Spinosad
disease MESH Rickets
disease VO effective

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