Inclusion of appendices to clinical study reports in marketing authorisation applications

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/EWP/2998/03
Effective from01/12/2004
KeywordsClinical study report, initial application dossier, study information, protocol, patient data listing, adverse event, case report form (CRF)
DescriptionThis document clarifies which appendices to clinical study reports should be systematically included in marketing authorisation applications and which may be available on request of the competent authorities.

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