Fig. 1

Process steps to create the data inventory for common data elements in clinical trials and their frequency of documentation in European EHR systems. First, clinical trials were collected and imported into the trial master database (TMDB). Then forms were categorized into domains, and all data elements were normalized. Top data elements per form domain were determined. Top form domains were reviewed by EFPIA partners. Afterwards, at a face-to-face meeting all elements were jointly discussed with academia and pharmaceutical partners. Finally, clinical sites identified element presence and performed data exports to determine the frequency of documentation