The Clinical Data Interchange Standards Consortium (CDISC) has released an annotated case report form (CRF) template to help sites apply CDISC standards to data anomalies resulting from trial adjustments during the COVID-19 pandemic as part of its new user guide.
The Novel Coronavirus Acute Respiratory Infection Clinical Characterization Data Tool was developed by the World Health Organization and the International Severe Acute Respiratory and Emerging Infection Consortium.
The guide’s recommendations for ongoing studies disrupted by COVID-19 include methods for listing COVID-19-related impacts as part of the clinical study report as well as how to handle protocol deviations, missed visits and assessments, changes to adverse event data collection, and patient transfers to another site due to site closure.
The CDISC guidance also offers data structuring recommendations for trials of COVID-19 vaccines and treatments that include patients with pre-existing medical conditions. The guidance provides recommendations on how to record whether healthcare workers wore personal protective equipment and/or if they came into contact with infected people or facilities that contained the coronavirus. Recommendations on how to record onset of disease, signs and symptoms, laboratory test results, and hospitalizations are also provided.
A CDISC task force of industry researchers, data standards experts and academic researchers formed in March developed the user guide in just under a month. “Because so much relies on our standards, CDISC teams are very meticulous, and we take our time to build these standards carefully,” says David R. Bobbitt, CEO of CDISC.
Find the full CDISC User Guide here: https://bit.ly/2Y5mt4m.