A trial master file that fills itself from the work already happening.
Most TMF effort is not filing, it is catching up on documents produced weeks ago by people who considered the job done when they signed them. If signing and filing happen in the same platform, the gap closes on its own.
- DIA TMF Reference Model
- Continuous completeness
- Version control
- Audit export
- Artefacts expected
- 412
- Filed and current
- 381
- Placeholder only
- 17
- Missing
- 14
Measured continuously, not reconstructed before an audit.
What filing looks like when it is not a separate task.
A monitoring report is signed. Nobody uploads anything.
- eTMFFiled to the monitoring artefact for Site 04
- Site fileSite's own copy indexed at the same version
- CompletenessSite 04 monitoring artefact marked current
- FindingsOpen actions carried to the next visit
- Audit trailSignature, actor and timestamp recorded
Structure, status and evidence.
Reference Model structure
Zones, sections and artefacts per the DIA TMF Reference Model, tailorable per study.
Version control
Supersession is explicit and prior versions stay retrievable with their dates.
Live completeness
Missing, placeholder and superseded distinguished continuously, per artefact and per site.
Shared with the site file
One document satisfies both indexes rather than existing as two uncoupled copies.
Role-scoped access
Sponsor, CRO and site boundaries applied to documents as to everything else.
Audit export
Export the structure, the documents and the trail behind them for inspection.
Common questions
Is the structure based on the DIA TMF Reference Model?
Yes. Zones, sections and artefacts follow the DIA TMF Reference Model, and the structure can be tailored per study — artefacts that do not apply to a study are not counted against its completeness.
What does 'fills itself' actually mean?
Documents produced by work elsewhere in the platform — signed delegation logs, monitoring reports, ICF versions, training records, safety letter acknowledgements — file to their TMF artefact at the moment they are completed. It does not mean documents created outside MonitoHQ appear on their own; those are uploaded like anywhere else.
How is completeness measured?
Against the study's configured expectation, per artefact, and continuously rather than at milestones. What is missing, what is placeholder-only and what is superseded are distinguishable at any moment, not just before an inspection.
Does this replace the investigator site file?
No — they are different files with different owners. MonitoHQ keeps both indexes over shared documents, so a document required in both is filed once and satisfies both, without the copies drifting apart.
Connected in the same platform
Bring a TMF you had to prepare for inspection.
30 minutes with a founder. We'll show what completeness looks like when it is measured continuously rather than reconstructed in the eight weeks before an audit.