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Étiqueté : Confidentiality

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Health Research Authority’s Guidance on the use of the UK template Confidentiality Disclosure Agreements: model Confidentiality Disclosure Agreement (mCDA) and model Master Confidentiality Disclosure Agreement (mMCDA)(Catapult’s regulatory round-up – May 2024)

A study-specific CDA template and its associated guidance have been produced by a UK-wide partnership to help make the early sharing of information, for feasibility and site set-up purposes, clearer and more efficient in line...

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EMA – Publication of the Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

This document gives general guidance to applicants/marketing authorisation holders (MAHs) on the retention/removal of personal data (PD) and identification of commercially confidential information (CCI) when drafting risk management plans (RMPs) in the pre-approval process, and...