An investigator site file that tells you what is missing.
Most electronic site files are storage. The useful part is the opposite: knowing which required documents are absent, out of date or superseded, per site and per study, without opening a folder to check.
- Configurable index
- Expiry tracking
- Per-site status
- Feeds monitoring
- Documents expected
- 64
- Filed and current
- 58
- Expiring in 30 days
- 3
- Missing
- 3
The same index, evaluated the same way at every site.
The index, per site.
Configured once for the study, then evaluated continuously against every active site. Illustrative data.
| Document | Section | Version | Status | Expires |
|---|---|---|---|---|
| Signed protocol | Protocol | v4.0 | Current | — |
| ICF — German | Consent | v3.1 | Current | — |
| Delegation log | Personnel | v6 | Current | — |
| CV — Dr. K. Hoffmann | Personnel | — | Expiring | 18 Mar |
| GCP certificate — S. Müller | Training | — | Missing | — |
| Lab certification | Facilities | — | Missing | — |
| IP shipping records | IP | — | Current | — |
| Insurance certificate | Regulatory | — | Expiring | 02 Apr |
A folder cannot tell you what should be in it. Our tracker does.
Storage answers what is here. A tracker answers what should be here, at this site, today — which is the question monitoring runs on.
One index across every site
The same expectation at every site, so completeness is comparable rather than folder-dependent.
Any CRA can pick it up
A replacement CRA opens the same tracker and sees the same status. Handover stops depending on notes.
No spreadsheets in SharePoint
The tracking spreadsheet and its stale copies go away — status is read from the documents.
Embedded in the platform
Gaps surface in visit preparation and become findings inside the monitoring workflow.
Expiry is watched for you
CVs, GCP certificates, licences and insurance, tracked against their dates.
Configured per study
A device study and an oncology study get different indexes, not one generic checklist.
Configuration, status and everything downstream.
Per-study index
Expected documents, scope and completeness rules, defined per study.
Versioned documents
Supersession is explicit. The current version is unambiguous, older ones stay retrievable.
Expiry tracking
Dated documents are watched, with warning before they lapse.
Feeds monitoring
Gaps appear in visit preparation and can be raised as findings in place.
Shared with the eTMF
One document satisfies both indexes without a second upload.
Scoped access
Sites see their own file. Sponsors and CROs see across sites, subject to role.
Common questions
What is the difference between an eISF and an eTMF?
The investigator site file is the site's copy of the essential documents for a trial; the trial master file is the sponsor's. They overlap heavily but are not the same set, they are owned by different parties, and a document can be required in one and not the other. In MonitoHQ they are separate indexes over shared documents, so filing to one can satisfy the other without a second upload.
Can the index be different per study?
Yes — that is the point of it being configurable. Each study defines which documents are expected, whether they are per-site or per-person, whether they expire, and what counts as complete. A device study and an oncology study do not get the same index.
How do missing documents reach the monitor?
A gap in the index is a flag on the site. That flag appears in the CRA's preparation step for the next visit and can be raised as a finding during it, so document chasing happens inside the monitoring workflow rather than by email.
What happens when a document expires?
Documents with expiry dates — CVs, licences, training certificates, insurance — are tracked against those dates. The site and the CRA see what is expiring before it lapses rather than after.
Connected in the same platform
Bring your ISF index.
30 minutes with a founder. Show us the index you use today and we'll configure it live, then show what a missing-document flag does to a monitoring visit.