International Trial Master File (TMF) Day

Founder of International TMF Day

Founded in 2025 by Sarah Hitching who set up Hedian in 2019 after many years of clinical trial and TMF experience.

Why International TMF Day Matters

It is a time each year to celebrate the role of TMFs in protecting clinical trial integrity, patient safety, inspection readiness as well as TMFers.

Community Participation

How to get involved:

  • Post using #InternationalTMFDay
  • Celebrate with colleagues
  • Recognize TMF professionals
  • What will you do to celebrate in 2027?

TMF Statistics

  • 100% of trials require a TMF
  • Most inspection findings are identified in the TMF
  • There are 250 artefacts in the TMF Reference Model

The Timeline

10 June 1996

ICH E6 (R1) published

Step 4 of the ICH process was published on 10th June 1996. The final step 5 version approved by the Committee for Propriety Medicinal Products (CPMP)was published in July 1996.
10 June 2010
TMF Reference Model V1.0 released
Hedian sat on the working group within DIA for this initiative and contributed to zone 11 (Statistics). The DIA presentation for TMF Reference Model V3.1 shows the timeline for the TMF Reference Model.
march – May 2025
initial Idea for international TMF Day
The idea was inspired by:
27 May 2025
International TMF day launched
The first mention of this celebratory day was on LinkedIn. It received over 70 reactions and 16 reposts.
10 june 2025
International TMF Day first celebrated
Celebrated on the day in LinkedIn by Sarah HitchingKaren Roy and Jamie Toth. Both Karen and Jamie sit on the CDISC TMF Steering Committee.

The TMF is the evidence of what happened in the trial.


A TMF is the collection of essential documents for a clinical trial. These provide evidence the clinical trial was conducted in accordance with regulatory requirements, Good Clinical Practice (GCP) and lastly the approved study protocol. But it is also so much more…..

Inspection Readiness

Ensuring TMF records supports regulatory inspections as well as client and internal audits.

Patient Safety

Providing evidence that patient safety remained a priority throughout the trial.

Data Integrity

Maintaining confidence in clinical trial outcomes.

Operational Excellence

Supporting effective trial management, decision making and oversight.

Find out about our services

Click the buttons below to find out about the TMF Services we offer.

Get in touch

For more information about how Hedian can help you with your TMF challenges and how our services can help your business, please get in touch.

We offer a free no obligation initial meeting.