EU Clinical Trials Regulation (CTR 536/2014)
CTR - Conduct, Manufacturing and Labelling (Ch VIII-X)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.47: Compliance with the protocol and Good Clinical Practice (Article 47)

Article 47 requires the sponsor and the investigator to ensure that the clinical trial is conducted in accordance with the protocol and the principles of good clinical practice (GCP). The reference document for GCP in the EU is the ICH GCP guideline (currently E6(R3)) as adopted by the Commission. Sponsors and investigators must comply with the protocol, GCP and the applicable scientific guidelines.

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

What else in your programme already covers this

This control maps to 2 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.

ICH E6(R3) - Good Clinical Practice · 2 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 - Conduct, Manufacturing and Labelling (Ch VIII-X)

Query this from an agent

The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.

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