To help investigators implement the Malaria Therapeutic Area Data Standard (TAUG-malaria) developed in partnership with CDISC we are delighted to share a standardised Case Record Form (CRF) which facilitates the collection of relevant clinical data according to CDASH (Clinical Data Acquisition Standards Harmonization) standards* and will map the data to the SDTM (Study Data Tabulation Model). Our CDASH compliant CRF is intended to be used by persons involved in the planning, collection, management and analysis of antimalarial clinical trials and clinical studies to ensure compliance to regulatory requirements for submission. We also hope it will promote data interchange allowing data to be pooled and shared, and ensure that clinical malaria data is appropriately archived and available for further analysis and reporting. We will develop training materials to accompany this CRF and the malaria standards in the coming months.
Download the malaria case record form (CRF).
Please email our Pharmacology Senior Scientific Coordinator Lesley Workman with your questions or suggestions for the CRF lesley [dot] workman [at] wwarn [dot] org