Chagas disease case report form

Working together IDDO, Drugs for Neglected Diseases initiative, and the Chagas disease research community engaged in a collaborative project to develop a freely-available case report form (CRF) for Chagas disease which has been annotated using CDISC standards.

Credit Ana Ferreira, DNDi

Why is a case report form needed?

Standard case report forms help improve the quality of data collection, and quality clinical research data informs and guides public health policy and facilitates drug development.

Collecting data in a standard format according to global standards also enables easier sharing of individual patient data. Up to now, there was no recognised standard approach to guide the recording, storing and reporting of Chagas disease clinical trial data. This made it harder to compare treatment efficacy data from different groups of researchers.

A Chagas Case Report Form

In 2022, IDDO launched a collaborative effort with Drugs for Neglected Diseases Initiative (DNDi) to create a CDISC-compliant template Case Report Form (CRF) for chronic indeterminate Chagas disease. We worked with the Chagas research community from across endemic regions to develop this form.

The new case report form is now available to use. It is compatible with the Clinical Data Interchange Standard Consortium (CDISC), enabling better information, data sharing and more efficient research.

The CRF does not prescribe what data to collect: it is a template that provides researchers with a standardised means of recording the data they choose to collect for their study.

An accompanying user guide will be available soon. It will cover a range of areas, including the creation of new CDISC domains, timing considerations, subject and disease characteristics, disease assessments, routinely collected data and analysis considerations.