Use cases for development, optimisation and implementation of artificial intelligence methods for real world data analyses in regulatory decision-making and health technology assessment along the product lifecycle (Real4Reg)

First published 29/06/2023

Last updated 23/04/2024

EU PAS number:

EUPAS105544

Study

Ongoing

Yes

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

Declarations_of_Interest_Real4Reg

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Composition of steering group and observers

WP leaders R4R

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Signed code of conduct

ENCePPCoCAnnex3_DeclarationofcompliancewiththeENCePPCodeofConduct_Real4Reg.pdf

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Signed code of conduct checklist

Checklist_Code_of_Conduct_Real4Reg.pdf

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Signed checklist for study protocols

Checklist_study_protocols_Real4Reg_spring_2024.pdf

English (1.52 MB - PDF)View document

Data sources

Data source(s), other: - Registo Oncológico Nacional (RON) - Portugal;
- Individual-level data collected from the Finnish national healthcare, mortality and population registers and censuses - Finland;
- Health Data Lab - Germany.

Data sources (types): Administrative data (e.g. claims)
Disease registry
Drug dispensing/prescription data
Electronic healthcare records (EHR)
Population registry

Use of a Common Data Model (CDM)

Data quality specifications

Data characterisation

Secondary tabs