TMF Classes

Study teams invest years of work into a clinical trial. The Trial Master File (TMF) is how that work is proven.

And TMF knowledge is no longer limited to TMF roles. Clinical functional leads are increasingly expected to understand their responsibilities for TMF content, oversight and inspection readiness.

This four-session live masterclass is for experienced TMF professionals and clinical team members ready to move beyond the basics and think in terms of evidence: what a process should create, whether the plan is being followed, and what your metrics are really telling you.

This isn’t an introduction to the TMF. It’s designed to help you level up.

Course Details

When: Tuesdays, 11:00 a.m.–1:00 p.m. Central USA

(12:00 p.m.–2:00 p.m. Eastern, 9:00–11:00 a.m. Pacific)

Format: Live and virtual, limited to 8 participants

Includes:

• A session takeaway sheet after each session

• Recordings for 60 days

• A 30-minute 1:1 follow-up

• A certificate of completion

Who It’s For

TMF professionals ready to level up their knowledge, expertise, and career, as well as clinical team members who want to go beyond the basics and strengthen their understanding of TMF oversight and expectations. Hands-on TMF experience or foundational TMF knowledge is recommended.

The Sessions

1. Plan with the End in Mind · Feb 9, 2027

Most TMF problems start long before anyone notices them. This session treats the TMF Plan and TMF Index as planning tools, not filing guides.

• Building a TMF Plan that reflects the sponsor’s role, even when a service provider manages the TMF

• Setting sponsor standards and adapting them to each study

• Using the TMF Index to define expected records, ownership and where records live, inside and outside the electronic TMF (eTMF)

• Fit-for-purpose planning under the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice guideline

You’ll leave able to: build a plan and index that anticipate the evidence your study will need.

2. Following the Process · Feb 23, 2027

A complete TMF isn’t the same as a TMF that proves the study was run as planned.

• Reading study plans (monitoring, data management, statistical analysis) to determine expected evidence

• Running cross-functional completeness reviews

• Telling a missing record apart from a process that wasn’t followed

You’ll leave able to: review a TMF against what the study said it would do.

3. Reading TMF Health · Mar 9, 2027

Metrics should raise questions, not just fill a dashboard.

• Key Performance Indicators (KPIs) vs. Key Risk Indicators (KRIs)

• Spotting trends across sites, countries and functions

• Root cause thinking and deciding what to act on

• A real-world case study: what do 80 findings at two sites tell you about the rest?

You’ll leave able to: turn TMF metrics into the right questions and next steps.

4. Leading an Inspection-Ready TMF · Mar 23, 2027

The TMF is a team effort, and someone has to lead it.

• Engaging study teams and building shared ownership

• Overseeing service providers

• Escalating issues and communicating TMF health to leadership

• Capstone: responding to a mock inspection request using everything from Sessions 1–3

You’ll leave able to: lead the TMF and the people behind it with confidence.

Founding Cohort

$995 through December 18

$1,195 beginning December 19

Registering 2 or more people from your organization? Use code TEAM10 for 10% off each seat.

What I’ll ask of you

As a founding participant, you’re helping shape this course for future cohorts. In return for the founding rate, I’ll ask you to:

• Come ready to participate. Join live when you can, share your experiences (anonymized, of course), and bring your questions.

• Try the between-session tasks. Each one is short and applies the topic to your own work.

• Share honest feedback through a brief survey after each session and at the end of the course.

• Consider a short testimonial if the course was valuable to you. It’s completely optional, and nothing is shared without your permission.

All registrations are subject to the Course Terms. By registering, each participant agrees to comply with them. Need an invoice for your company? Email info@iceconsultingllc.com.