Publications

• The Decommissioning of Computerised Systems Used in Clinical Trials (April 2023)
• Nature of a Distributed Trial Master File TMF) ‐ Practical Aspects (April 2023)
• Data Formats Used in Clinical Trials (April 2023) 

The three white papers above were written by a joint task force from EUCROF and the eClinical Forum: They provide details of the positions described in a position paper titled “Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials” released on 26 February 2021 (below).

• Propositions on Remote Source Data Verification and Remote Source Data Review - A Proposition Paper from EUCROF’s rSDV/rSDR Task Force (March 2023)
• CRO Insights and Experiences: How to solve challenges on the implementation of DCT elements in clinical research (Fiona MAINI, Yoanni Th. MATSAKIS)
• "Implementing Decentralised Clinical Trials in Italy-Why and How" (June 2022) - Dr Stefano Marini is co-author of chapter at page 205. The other authors are very well know people of the AIFA agency, MoH, academy, hospitals, institutions etc.. -  Implementing Decentralised Clinical Trials in Italy - Why and How.
• "Combination Products" - article written by the EUCROF Medical Devices WG (June 2022) - Combination Products - article by EUCROF MDWG (June 2022)
• Clinical Evaluation vs. Clinical Investigation Document (EUCROF Medical Device Working Group) - Clinical Evaluation vs. Clinical Investigation Document
• Propositions Paper on Remote SDV/SDR (endorsed by EFPIA - 2 June 2022) - rSDV Propositions Paper Version 3 Dated 16Jun2022
• AI in PV EUCROF Part 1
• AI in PV EUCROF Part 2
• EUCROF Publication list (19 March 2021) - EUCROF Publications List
• eConsent Implementation Guide - Electronic Informed Consent Implementation Guide - Practical Considerations
• Archiving Position Paper (26 February 2021) - Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials