On-site Access to Electronic Health Records by Sponsor Representatives in Clinical Trials

On 26 November 2020 the UK MHRA published the new guidance for Sponsors, CROs and investigator sites.

This guidance is for Sponsors, Contract Research Organizations (CROs) and investigator sites when considering management of personal data processed in relation to research. It should be read in conjunction with the Heath Research Authority (HRA)/MHRA joint advice on Data Protection Impact Assessments (DPIAs). In this context ‘processing’ also means access to Electronic Health Records (EHRs).

Historically, monitors could be provided with the physical records of individual trial participants, without also providing them access to the records of other patients. Where EHRs have been designed to allow similarly restricted access, access may continue to be provided as it has been. Where EHRs do not have this functionality, additional safeguards are required.

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