Launch of the first malaria therapeutic area data standard and new Case Record Form (CRF)
We are pleased to share with you the launch of the first malaria therapeutic area data standard (TAUG-malaria), developed in close partnership with the Clinical Data Interchange Standards Consortium (CDISC). CDISC facilitates the development of standards that support clinical data gathering, exchange, submission and archiving.
Until now there has been no international malaria data standard available to guide data capture to enable the assessment of antimalarial drug efficacy. This has resulted in large heterogeneity in data collected by researchers and drug developers. It is well-timed with the US FDA requiring submissions to adhere to CDISC data standards and the general trend of working towards more data sharing and access to data sets for all diseases.
“The malaria data standard was developed using a consensus-based collaborative effort involving research partners, policy-makers, industry investigators and regulatory authorities. We’re very grateful to many WWARN partners for their support and suggestions to help finalise the first TAUG-malaria standards.” acknowledges Prof Karen Barnes, Head of WWARN’s Pharmacology Scientific Group and lead for WWARN’s efforts to coordinate the development of the malaria standards.
To help investigators implement these standards we are also 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 the TAUG-malaria and CRF in the coming months. Read a news article with more background information on how the malaria standards were developed.
Share your questions on the training materials and Case Record Form with Lesley Workman, Senior Scientific Coordinator lesley.workman@wwarn.org
If you have any questions on the TAUG-malaria standard, please contact Alana St Clair, Project Manager astclair@cdisc.org. Please create a free CDISC account to download the TAUG-Malaria.
* CDASH establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review. Find out more.