Hedian Records Management Experience:
Hedian Records Management has the following experience:
June 2025 – Member of the CDISC + TMF Interchange Agenda Committee
Sarah Hitching became a member of the CDISC + TMF Interchange Agenda Committee.
27 May 2025 – Created International Trial Master File (TMF) Day – 10th June
International Trial Master file was the brainchild of Sarah Hitching who recognised that the TMF deserves its own celebratory day. A day for education, raising awareness and calling all trial team members to action to raise the priority of TMF filing.
The date was inspired by the first time the term ‘Trial Master File’ was used officially in the guideline International Council for Harmonisation of Good Clinical Practice Revision 1 (ICH GCP E6 R1). The date of this publication is 10th June 1996 – the perfect day for International Trial Master File Day!
September 2024 to ongoing – TMF Reference Model Version 4
A member of the Triage Committee working on Zone 2, checking suggested edits conform to Clinical Data Interchange Standards Consortium (CDISC) Guiding Principles before passing on to the Zone 2 team for further appraisal. CDISC TMF Reference Model Version 4 was kicked off at the 2024 CDISC + TMF Interchange US in Phoenix, AZ and is due to be completed by 2027.
January 2024 – May 2025 CDISC TMF Risk Based White Paper and Risk Tool
Sitting on the White Paper and Training Groups for the CDISC Risk Based project, the White Paper and the Risk Tool were launched at the 2025 CDISC + TMF Interchange EU, Geneva on 14May2025. You can find a the publications here on the ‘Risk’ tab.
19 July 2023 – ICH E6 R3 Feedback Provided
As a member of the HSRAA, feedback on the draft ICH GCP E6 R3 draft was provided and added to the HSRAAs feedback and sent to the Medical, Healthcare products and Regulatory Agency (MHRA).
23 February 2018 – TMF Plan Template
TMF Reference Model TMF Plan Template Working Group 2017 – 2018 resulting in the TMF Plan Template V1.0. This is now available to CDISC members and has been updated to V2.0 21Oct2022 (see TMF Resources).
12th April 2017 – 11 July 2017 – Provided feedback to EMA on Guideline on TMFs
Contributed to European Medicines Agency (EMA) consultation on the draft ‘Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials’. This guideline was published on 6th December 2018.
July 2016 – 31st October 2016 – Provided feedback on Data Integrity Guidelines (MHRA)
Contributed to MHRA Consultation on the draft ‘GxP Data Integrity Definitions and Guidance for Industry’. The Guidance on GxP Data Integrity were first published on 9th March 2018 and later updated.
October 2016 to present – Trainer at SAG
Training co-ordinator for Scientific Archivist Group (SAG), renamed Health Sciences Records and Archives Association (HSRAA) on 4th January 2018
24th June 2012 – Destruction of Paper V1.0
Member of the Document and Records Management (DRM) Special Interest Area Community (SIAC) that produced the DIA Framework for the Destruction of Paper Originals v 1.0. Now a resource on the CDISC TMF Reference model website to members (membership is free) and updated to V2.0 18th January 2019 (see TMF Resources).
4th June 2010 – TMF Reference Model V1.0
Worked on the TMF Reference Model v1.0, particularly attending regular teleconferences and contributing to section 11 (Statistics). The current version of the TMF Reference Model is available to members here.
30th June 2009 – Relevant Communications Policy
Lead on workstream for GCP-RMA and main author to produce Relevant Communications Policy. Now available on the Health Sciences Records and Archives Association (HSRAA) as a White Paper from the GCP SIG.
26th to 27th September 2007 – Initial TMF Reference Model
Member of the GCP-RMA Project Team which worked on the original process based fileplan which was later presented at the Drug Information Association (DIA) Document Management conference in Vienna, Austria. This formed the original basis of the TMF Reference Model. This referenced in the Trial Master File Wikipedia article.
For more information about Hedian Records Management and how our services can help your business or for a free no-obligation initial meeting, please contact us at info@hedianrm.com.