Article 80 establishes the EU portal as the single entry point for the submission of data and information relating to clinical trials in the Union (the public-facing layer of CTIS). Article 81 establishes the EU database for clinical trials (the regulatory-facing layer of CTIS). Article 82 governs the functionality of the EU portal and the EU database: data quality, public access to the public layer, confidentiality of commercially confidential information (CCI), personal data protection, and data redaction rules. The Agency operates the EU portal and EU database in collaboration with the Member States and the Commission.
This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
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.
The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.