Visceral leishmaniasis case report form

Previously, there was no recognised standard approach to guide methods of recording, storing and reporting VL clinical trial data. This has resulted in challenges when comparing data relating to the efficacy of treatments from different groups of researchers.

Health department worker looking at paperwork
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Credit: Simone D. McCourtie, World Bank

Working together IDDO, Drugs for Neglected Diseases initiative, clinicians and scientists from the visceral leishmaniasis (VL) research community, pharmaceutical industry, drug regulators, and key national and global health partners have now developed the first freely-available poverty-related infectious disease case report form (CRF) to have been annotated using CDISC standards.

 

  • The new CRF allows collection of clinical trials data for uncomplicated VL in a standard format according to global data standards, facilitating the sharing of individual patient data (IPD) to address knowledge gaps, advance research and support subsequent drug development.
  • The CRF does not prescribe what data to collect, but rather is a template that provides researchers with a standardised means of recording the data they choose to collect for a study.

 

Read more about the VL global collaboration.

Further work will be conducted to address specific data collection for vulnerable populations.

Find out more about the process behind the development of a CRF

Download the CRF for uncomplicated VL

Download the user guide for the CRF for uncomplicated VL