Training records that sit next to the delegation they support.
Training and delegation are two halves of one claim: this person is permitted to do this task, and is competent to do it. Split across an LMS and a signed PDF, nothing checks that the two agree.
- Site staff
- CRO staff
- Version-aware
- Gates delegation
- Assigned
- 96
- Complete
- 86
- Retraining after amendment
- 8
- Blocking a delegation line
- 2
The CRO team is tracked in its own separate LMS.
Stop tracking training on paper and in your own spreadsheet.
Site and CRO training are separate obligations with separate owners, so they stay two separate systems. What goes away is the paper: attendance sheets at the site, and the spreadsheet a CRO keeps for its own team.
Site LMS
Protocol, ICF and equipment training per site and per person, with its own status view.
CRO LMS
Monitoring plan, SOP and system training for your CRAs — without building an internal tool.
No attendance sheets
Recorded against the individual, not a signed sheet scanned in at month end.
No tracking spreadsheet
The hand-kept matrix, and the copy that goes stale after the first amendment, both go.
Separate by design
Site staff are not your staff. Separate systems keep permissions honest.
Both gate delegation
Training required for a delegated responsibility shows unsatisfied on the delegation log.
The site LMS, and where it blocks delegation.
One site, its own people, and the training gaps that stop a delegation line being signed. The CRO team has a separate LMS of its own. Illustrative data.
| Person | Role | Course | Version | Status |
|---|---|---|---|---|
| Dr. A. Weber | Principal investigator | Protocol training | v4.0 | Complete |
| Dr. K. Hoffmann | Sub-investigator | Protocol training | v4.0 | Complete |
| S. Müller | Study coordinator | Protocol training | v3.0 | Retraining |
| S. Müller | Study coordinator | ICF administration | v2.1 | Overdue |
| M. Vogel | Sub-investigator | Protocol training | v4.0 | Not started |
| J. Becker | Pharmacist | IP handling | v1.2 | Complete |
Assignment, completion, consequence.
Curricula by role
What a coordinator, sub-investigator or monitor must complete, per study.
Version-aware
Records carry the version completed against. Amendments trigger retraining.
Gates delegation
Responsibilities requiring training show unsatisfied until it is complete.
Two separate LMS
One for site personnel, one for your own monitoring team. They stay apart.
Overdue visible
Outstanding training surfaces in monitoring preparation, not a monthly report.
Files automatically
Completion records file to the site file and eTMF personnel sections.
Common questions
Is this for site staff or for CRO staff?
Both, but in two separate systems. Site training and CRO training have different owners, different curricula and different auditors, so they are kept apart rather than merged into one catalogue. The site LMS covers site personnel; the CRO LMS covers your own monitoring team.
What happens when the protocol is amended?
Training is versioned against what it teaches. When the protocol moves to a new version, everyone trained on the old one is marked as requiring retraining, and the delegation records that depend on that training show the gap.
Can training gate someone's ability to work?
It can gate delegation. A responsibility that requires specific training shows as unsatisfied on the delegation log until that training is complete, so the conflict is visible to the PI signing it rather than discovered at an audit.
Do training certificates file to the site file automatically?
Yes. Completion records file to the investigator site file and, where required, the eTMF, against the personnel section for that individual.
Connected in the same platform
Bring a training matrix you maintain by hand.
30 minutes with a founder. We'll load it, version it against a protocol amendment, and show what happens to the delegation log.