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)

Documents

Study protocol

Initial protocol

Study_protocols_Real4Reg_2023_June_29

Updated protocol

Real4Reg_protocols_usecases_1-4_summer_2025.pdf

First published: 10/07/2025

Study_protocols_Real4Reg_2024_April_11.pdf

First published: 09/04/2024

Study results

Study report

Other information

Study, other information

WP leaders R4R_2025.pdf

Checklists protocols UC1-4_signed.pdf

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

The use of the ENCePP Seal has been discontinued since February 2025. The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

Declarations_of_Interest_Real4Reg_2024.pdf

Composition of steering group and observers

WP leaders R4R_2024.pdf

Signed code of conduct

ENCePPCoCAnnex3_DeclarationofcompliancewiththeENCePPCodeofConduct_Real4Reg.pdf

Signed code of conduct checklist

Checklist_Code_of_Conduct_Real4Reg.pdf

Signed checklist for study protocols

Checklist_study_protocols_Real4Reg_spring_2024.pdf