TMF Risk Based Approaches
Hedian was involved in the CDISC TMF Risk Based Initiative between January 2024 to May 2025.
The White Paper and the Risk Tool were launched at the 2025 CDISC Interchange, Geneva, Switzerland on 14th May 2025.
You can find the publications here under ‘TMF Resources’ and on the ‘Risk’ tab.
TMF Reference Model
Hedian contributed to the TMF Reference Model v1.0 released on the 10th June 2010. The current version of the TMF Reference Model is available to CDISC members here.
Part of the GCP-RMA Project Team in 2007, Hedian helped produce the first process based standard TMF Fileplan. This TMF Fileplan helped to form the original basis of the process based TMF Reference Model as cited in the Trial Master File Wikipedia article.
TMF Working Parties
CDISC Interchange Agenda Committee since June 2025.
CDISC TMF Standard Model V1.0 Triage Committee member from September 2024.
CDISC TMF Reference Model TMF Plan Template V1.0 23Feb2018. This is now available to CDISC members as V2.0 21st October 2022 (see TMF Resources).
DIA Framework for the Destruction of Paper Originals V 1.0, 24th June 2012. This is now a resource to CDISC members as V2.0 18th January 2019 (see TMF Resources).
HSRAA Relevant Communications Policy 30th June 2009 (Lead author), available on the HSRAA website under ’White Papers from the Good Clinical Practice SIG’.
Regulations
ICH Good Clinical Practice (GCP) E6 R3 guidelines – provided feedback on 19th July 2023.
EMA’s Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials – provided feedback 12th April to 11th July 2017.
MHRA’s GxP Data Integrity Definitions and Guidance for Industry – provided feedback July to 31st October 2016.
Get in touch
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*1 Good Clinical Practice – Records Management Association (GCP-RMA) amalgamated with the Scientific Archivists Group (SAG) on 10th March 2016. SAG became HSRAA on 4th January 2018.