Details of person submitting   
Name Jagat Mishra
Organisation Parexel
Details of abstract   
Title of abstract  GDPR plus Blockchains- A Novel approach in Clinical Data Management

Exponential growth of digital data has led to substantial increase in data breaches, to meet the privacy concerns and safeguards of personal data, the EU Parliament adopted the General Data Protection Regulation (GDPR) in 2018 it is latest development of the EU’s efforts to protect the personal data of its citizens & its main purpose is to give individuals more power to protect their personal data and to understand how their information might be utilized by the Sponsor or CRO collecting that data, Personal data should be ‘processed lawfully, fairly and in a transparent manner’ & must be ‘kept in a form which permits identification of data subjects for no longer than is necessary for the stated purposes, failure to comply GDPR fines will be up to €20 million or 4% of annual turnover of organizations. Clearly GDPR compliance is mandatory in clinical trial data collection which could be achieved by adoption of BLOCKCHAINS which is a decentralized database where all data is encrypted and hashed using pseudo anonymization adding the trinity of T’s (trustability, transparency and traceability) to data, allows subjects’ personal & other metadata, when stored in Blockchain itself cannot be modified, Clinical trials data could be collected in private, permissioned blockchain networks With smart contracts options, allowing ultimate security and data sharing capabilities and offers competitive edge over legacy data collection and management practices along with high scalability, GDPR amalgamation with Blockchain brings a new paradigm of data management, storage & governance in clinical trials and offers novel approach for managing subject’s data and shortening lab to market time span. GDPR empowers data subjects by introducing new rights to existing data protection directives.


First learning objective GDPR in Clinical trials
Second learning objective Blockchains
Third learning objective
Presenter Details  
Name  Jagat Mishra 
Organisation Parexel
Job title Clinical Data Analyst