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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

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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.

Read the full article here

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