Analysis of pregnancy pharmacovigilance data in spontaneous reports, and literature, (Individual Case Safety Reports originating from published case series, non-interventional studies and patient support programmes); demonstration study 2.5.1 of the ConcePTION project

First published 06/01/2021

Last updated 23/04/2024

EU PAS number:

EUPAS38841

Study

Planned

Documents

Study protocol

Initial protocol

Protocol_ConcePTION_Demo2_5_1_V1.0

English (1.19 MB - PDF)View document

Study results

Study report

Other information

ENCePP Seal

This study has been awarded the ENCePP seal

ENCePP Seal documents

Conflicts of interest of investigators

ENCePP DoIForm_v1.6_EvP

English (890.4 KB - PDF)View document

Composition of steering group and observers

EUPAS38841_steering group

English (317.33 KB - PDF)View document

Signed code of conduct

ENCePPCoCAnnex3_DeclarationofcompliancewiththeENCePPCodeofConduct

English (628.94 KB - PDF)View document

Signed code of conduct checklist

EUPAS38841-38876

English (896.47 KB - PDF)View document

Signed checklist for study protocols

ENCePP Checklist for Study Protocols_YW

English (495.81 KB - PDF)View document

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