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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)

29/06/2023
20/11/2025
EU PAS number:
EUPAS105544
Study
Ongoing
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Documents
Study protocol
Initial protocol

Study_protocols_Real4Reg_2023_June_29

English (1.35 MB - PDF) View document
Updated protocol

Real4Reg_protocols_usecases_1-4_summer_2025.pdf

First published: 10/07/2025
English (2.74 MB - PDF) View document

Study_protocols_Real4Reg_2024_April_11.pdf

First published: 09/04/2024
English (1.48 MB - PDF) View document
Study results
Study report
Other information
Study, other information

WP leaders R4R_2025.pdf

English (407.74 KB - PDF) View document

Checklists protocols UC1-4_signed.pdf

English (9.2 MB - PDF) View document

Declarations_of_Interest_Real4Reg_2025.pdf

English (2.35 MB - PDF) View document
Publications
Study publications
The EU project Real4Reg: unlocking real-world data with AI Background The u…
Supplementing Single-Arm Trials with External Control Arms—Evaluation of German…
ENCePP Seal
This study has been awarded the ENCePP seal
Conflicts of interest of investigators

Declarations_of_Interest_Real4Reg_2024.pdf

English (2.27 MB - PDF) View document
Composition of steering group and observers

WP leaders R4R_2024.pdf

English (77.94 KB - PDF) View document
Signed code of conduct

ENCePPCoCAnnex3_DeclarationofcompliancewiththeENCePPCodeofConduct_Real4Reg.pdf

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Signed code of conduct checklist

Checklist_Code_of_Conduct_Real4Reg.pdf

English (2.64 MB - PDF) View document
Signed checklist for study protocols

Checklist_study_protocols_Real4Reg_spring_2024.pdf

English (1.52 MB - PDF) View document