EU Clinical Trials Regulation (CTR 536/2014)
CTR - CTIS, Cooperation and Final Provisions (Ch XIV-XIX)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.93: Data protection (Article 93)

Article 93(1) provides that the Regulation applies without prejudice to GDPR for the processing of personal data carried out in the Union for the purposes of the Regulation. Article 93(2) requires Member States to apply the GDPR national-derogation rules to the processing of personal data in clinical trials. Article 93(3) governs the processing of personal data within the EU portal and the EU database. The sponsor and the investigator process subject personal data (including special-category health data) under Article 6 + Article 9(2)(i) (public health) or Article 9(2)(j) (scientific research) GDPR.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 4 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

GDPR · 4 controls

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in CTR - CTIS, Cooperation and Final Provisions (Ch XIV-XIX)

Query this from an agent

The graph holds this control, the 4 it maps to, and the evidence behind each claim, over MCP and REST.