celebrating International 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
how was the date chosen?
The Timeline
ICH E6 (R1) published
- International Women’s Day celebrated on 8th March and
- International Clinical Trials Day which takes place on 20th May
Why celebrate TMFs?
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.
