Module 5 Presentations

19/07/2024

• Scope of legislation Data Privacy

– Covers processing of information – “Processing” given broad meaning: • Merely holding data

• Altering the form in which data are held • supplying to third parties – Particular restrictions imposed on processing “personal data” and “sensitive personal data” – Information requirements for subjects: • identifying data controller etc • notification of rights (note access rights) – Exemptions (research purposes, further research and subject access) – Transfer outside EU ● NB consent to participate in a trial is different from any consent to process personal data obtained from trial participants .

The Organisation for Professionals in Regulatory Affairs

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GDPR and clinical trials

• Processing of personal data must have a lawful basis under Art 6; in a trial context, likely to be: • Consent • Legitimate interests • Legal obligation • In addition, where the data are special category data, a condition under Art 9 must also be met; in a trial context likely to be: • Consent • Public interest in the area of public health (includes quality and safety of medicinal products).

The Organisation for Professionals in Regulatory Affairs

14

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