The investigator can delegate trial tasks, but not responsibility. The delegation log records who may do what, from when, and it should agree with who can actually do those things in your systems.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Staff
7
Signed off
6
Training
7/7
Key points
Template
| Column | Content |
|---|---|
| Name | Full name of the staff member. |
| Role | Sub-investigator, research nurse, coordinator, pharmacist, etc. |
| Delegated tasks | Task codes from the list below. |
| Start date | Date delegation starts; not before training is complete. |
| End date | Date delegation ends; the row is kept. |
| Signature and initials | Specimen signature and initials of the staff member. |
| Investigator sign-off | PI initials and date authorising the delegation. |
Task codes
| Code | Task | Typically delegated to |
|---|---|---|
| 1 | Obtain informed consent | Investigators, trained research nurses (per local rules) |
| 2 | Confirm eligibility | Investigators |
| 3 | Collect medical history and con meds | Coordinators, nurses |
| 4 | Physical examination | Medically qualified staff |
| 5 | Assess adverse events and causality | Investigators |
| 6 | Sign eCRFs and SAE reports | Investigators |
| 7 | eCRF data entry | Coordinators, nurses |
| 8 | Query resolution | Coordinators, investigators |
| 9 | Investigational product dispensing and accountability | Pharmacists, trained staff |
| 10 | Sample collection and processing | Nurses, lab staff |
Adapt codes to your protocol and local regulations.
In Capture
Each site passes an activation checklist before it opens, including the delegation log. Team members acknowledge SOP training, roles control what each person can do, and electronic signatures made under delegation are recorded as such. The delegation log can be exported for the investigator site file.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Invite a test team in the free sandbox and activate a site.
Inspection view
Inspectors compare the delegation log with what actually happened. The findings are predictable: a coordinator obtained consent without being delegated the task, a sub-investigator signed eCRFs before the PI signed off their entry, a staff member started work before their training was complete, or someone who left months ago still has an open row and an active login.
Most of these come from treating the log as a document filled in once at site initiation. It works better as a living record reviewed at every monitoring visit: new staff added before they start, tasks changed when roles change, and end dates entered the day someone leaves, together with removal of their system access.
Compare consent form signatures with the staff delegated consent; eCRF signatures with those delegated signing; dispensing records with pharmacy delegation; and training records with start dates. In an electronic system, the audit trail shows who entered and signed what, which makes the comparison much faster than paper.
At every monitoring visit
Compare with the site team and system users.
No task performed before the sign-off date.
Protocol and system training dated before start.
Medical tasks with medically qualified staff.
End date entered and access removed the same day.
Specimen signature and initials for everyone listed.
Each staff member signs or initials their own entry, and the principal investigator authorises each delegation, usually with initials and date.
The original is kept in the investigator site file. Monitors review it, and sponsors often keep a copy in the trial master file.
A record kept by the investigator of which qualified staff are authorised to perform which trial tasks, from which dates.
ICH GCP requires the investigator to maintain a list of qualified persons to whom significant duties are delegated; the delegation log is the usual format.
No. Tasks can be delegated, but the investigator remains responsible for the trial at the site.
Add an end date to their entry and remove their system access; do not delete the row.
Yes. The delegation log can be exported, and it is part of the site activation checklist.
Keep exploring
Clinical trial study start-up software
Site activation.
FDA inspection checklist
Delegation is inspected.
Data management plan template
The other key study document.
Good clinical practice
Where the requirement comes from.
Electronic signatures
Signing under delegation.
Software for research coordinators
The people on the log.
Site activation, training and roles. Free sandbox.