This metadata describes the data format for data contributions to the International COVID-19 Data Alliance (ICODA) driver project investigating the safety and efficacy of clinical trials. The first data dictionary was published in December 2020, newer versions are available.

Several thousand clinical COVID-19 trials were in progress globally. As these trials were all evaluating the benefit/risk of potential COVID-19 treatment options, it was vital that the scientific community could interrogate this data as it emerged.

The summary level data from some of these trials across industry, academia and government was included in the ICODA Workbench. In order to provide near-immediate access to results and data from the trials, ICODA has partnered with Certara to provide curated and digitised summary level data from key trials as they were reported in the public domain. In addition, several data contributing organisations provided enriched summary-level data within 5-30 days post top-line reporting of the trial results which allowed a more in depth evaluation of the results.

This Driver project used a Data Dictionary to harmonise variable definitions and subgroup classifications from all trials. This allowed side by side interrogation of the data from these trials making the data readily useable to interpret findings. Researchers could also view data from individual trials in the context of other available trials thus expanding their insights. Our visual analytics and meta-analyses tools further enhanced the researchers’ ability to work quickly.