[INFOGRAPHIC] General Data Protection Regulation (GDPR) and Health Data Challenges

GDPR will entry into force in the 25 May of 2018. CROS NT proposes an infographic about with a focus on health data. De-identification involves removing or recoding health information that could identify and individual such as patient identifiers, free text verbatim terms or references to dates. Subsequently, data anonymization involves destroying all links between the de-identified…

Medical Coding in Data Management: Manual vs Auto-Coding

Medical coding is an important step in data cleaning activities within data management. The main objective of performing medical coding is to have the medical terms interpreted uniformly and in a standardized format; hence medical coding is required to be completed by using standardized medical dictionaries. In CROS NT coding is usually performed within the…

Pathway to a Statistical Risk-Based Monitoring Approach

With the onset of the new ICH E6 R2 regulatory guidelines in mid-June this year, clinical trial sponsors and CROs are gearing up and tightening the framework for launching new risk-based management approaches to onsite monitoring activities. The new addendum represents the largest revision to ICH guidelines in 20 years and places all responsibility of…