Transcription of Guidance for the format and content of the protocol of non ...
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Guidance for the format and content of the protocol of non ...
26 September 2012. EMA/623947/2012. Patient Health Protection Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies Introduction From 10 January 2013, marketing authorisation holders have the obligation to comply with the format and content of the study protocol for post-authorisation safety studies (PASS), as specified in Art 36 to 38 and Art 40 of the Commission Implementing Regulation (EU) No 520/2012. Use of the format is encouraged for PASS protocols submitted before that date. This document provides Guidance for drafting the study protocols for non-interventional PASS in order to support consistency of the presentation and information provided.
The study protocol should be concise, while providing the information needed to understand how the study will answer the research question and assess the validity of the study design. All headings and sub-headings of the format presented in this guidance should always be included and the same numbering should be used.
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