EU Clinical Trials Regulation (CTR 536/2014)
CTR - Start, End and Safety Reporting (Ch VI-VII)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.41_42: Adverse-event and SUSAR reporting (Articles 41-42)

Article 41 requires investigators to record and report adverse events and serious adverse events specified in the protocol to the sponsor within specified timeframes. Article 42 requires the sponsor to report SUSARs to the Agency (EMA, via EudraVigilance) without undue delay: fatal/life-threatening SUSARs within 7 days, other SUSARs within 15 days, including follow-up reports within 8 days from the initial report.

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 3 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

ICH E6(R3) - Good Clinical Practice · 2 controls

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) · 1 control

  • IVDR-Art.56_57_58 Performance evaluation, performance studies and additional requirements (Articles 56-58)

EU Medical Devices Regulation (MDR 2017/745) · 1 control

  • MDR-Art.70_74_75_80_82 Clinical-investigation application + CE-marked-device studies + substantial modifications + adverse events + records (Articles 70, 74-75, 80, 82)

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 - Start, End and Safety Reporting (Ch VI-VII)

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.

MCP endpointAll EU Clinical Trials Regulation (CTR 536/2014) controls