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Establishing Metrics and Standardization for Non-CRF Data in EDC

 

Dr. Ashish Indani

Head-Research & Innovation, TCS ADD Platforms

Sharad Sharma

Domain Consultant-Clinical Data Management, Life Sciences & Healthcare

Shivaji Bote

Domain Consultant-Clinical Data Management, Life Sciences

Adopting a metric-based approach to monitor data on EDC platforms

The objective nature and confirmatory value of non-CRF data make it an essential source of information in any clinical study. However, the non-CRF data transfer process lacks parameter-based metrics critical to determining its efficacy and efficiency. In addition, there are several complexities in the data transfer process due to the absence of standard procedures and industry-wide conventions, coupled with the failure of non-CRF data to add to the quality and completion issues. Through this article, industry experts from TCS ADD Platforms highlight a few key approaches to iron out these inefficiencies including standardization of DTAs to a protocol, automation of data transfers and metric-based monitoring of incoming data. This article reimagines the entire data transfer process and highlights how technology would prove to be instrumental in unlocking pathbreaking capabilities.