Delegation that stays current, evidenced and provable on any date.
For NHS R&D offices, Principal Investigators and research units. AQ Digital DoA records who is authorised to do what, from which date and on which evidence — and the same record decides what each person can do inside the platform.
Illustrative study delegation matrix. Red: delegated and in date. Amber: evidence expiring, review due. Grey: not delegated. Each cell links to the CV, GCP certificate and training record that support it.
Delegation logs fail at the moment they are tested.
A delegation log records who the Principal Investigator has authorised, for which tasks, and from when. Paper logs, spreadsheets and PDFs share one weakness: the record sits apart from the training evidence, the system access and the study activity it is supposed to govern. NHS trust SOPs require PI sign-off before any activity, start and end dates for every person, and current CVs and GCP certificates for every name on the log. A static document cannot hold those conditions on its own.
“Tasks performed outside of the delegation period”, and “discrepancies between documented delegation of trial related tasks and actual activities performed”.
Activity before authorisation
Staff begin work weeks before the log is signed, and the PI signs after the first participant visit. The gap between first activity and effective date is the finding; a later signature cannot close it.
Evidence that lapses without warning
A GCP certificate or CV expires mid-study and the delegation stays on the log. Nobody is prompted, so the person continues to consent, dispense or assess on evidence that no longer supports it.
Access that does not match the log
Leavers retain system access and joiners act before their delegation is live. Access and delegation are administered in different places, so the two records drift apart.
History that must be reconstructed
A monitor asks who was authorised to take consent eighteen months ago. Superseded versions are missing and end dates were never entered, so the answer takes an afternoon of reconciliation.
Core capabilities of AQ Digital DoA.
Built for the way NHS research offices, Phase 1 units and site networks run delegation across many studies at once.
Study delegation log
A study-specific log built from a task library, with role profiles that pre-fill the usual tasks.
Linked qualifications and training
Each delegation is tied to the CV, GCP certificate, protocol training and SOP acknowledgements behind it.
Staff acceptance and PI signature
The delegate accepts the tasks, then the PI approves and signs electronically.
Permissions follow delegation
The delegation record decides what a person can do in the platform, from the effective date.
Checks before the action
Connected Intelligence checks delegation, training and evidence at the point of action, and flags the gap.
Cross-study delegation view
Every study a person is delegated on, every person on a study, and every gap across a site or network.
Version history and audit trail
Each change creates a new version with the actor, the time and the reason for change.
Monitor and inspector access
Read-only access to the log, its history and the linked evidence, scoped to one study for a defined period.
Leavers, role changes and close-out
End dates close access the same day, an incoming PI re-approves, and the final log is locked and filed.
Every delegate, every task, and the evidence behind each one.
Open a delegate to see what they are authorised to do, from which date and on which evidence — or follow one person from study set-up through to close-out.
ONC-2291 · Site 07 · Delegation of authorityCycling · select to stop21 CFR Part 11 signedEvidence held once, checked against every study.
Staff work across a portfolio, not a study. One certificate sits behind delegations on four studies at once — so one renewal clears all four, and until it is filed each affected delegation is flagged where it stands.
Research teams that hold many delegations across many studies.
One view of completeness, expiring evidence and pending PI approvals across every study.
Approve and sign from a phone between clinics, with every event dated by the system.
Role profiles make a new delegation a short, evidenced action rather than a rewrite.
Standard task libraries and role profiles applied across every site.
Read-only, study-scoped, time-boxed access to the live log and its history.
Built around what the regulations ask of delegation.
ICH E6(R3) 2.3.3 requires the investigator to maintain a record of the persons and parties to whom trial-related activities have been delegated; 2.3.1 requires proportionate oversight, and 2.3.2 ties training to the delegated activity. Since 28 April 2026 compliance with the ICH E6 conditions and principles has been a legal requirement for UK trials of investigational medicinal products, and NIHR guidance states the log must be completed before the delegated individual commences any study-related activity.
AQ Digital DoA is structured to support those expectations: a dated, attributable record, evidence linked to each delegated activity, and a history retained for the required period.
A task nobody is delegated to do cannot be booked, filed or dispensed.
The effective date is the control and the signature is the confirmation. Why effective dates matter more than signatures.
The person is on the team and their evidence is on file, but the delegated task is not available to them.
PI approval sets the date, and the platform grants the matching permission that day. Start dates are locked at approval.
Access is withdrawn the same day, and the log still answers who was authorised on any date in the study.
Questions sites, sponsors and monitors ask.
Anything not covered here, ask us directly at enquiries@aq-trials.com.
A delegation of authority log, also called a delegation log or delegation of duties log, records the people the Principal Investigator has authorised to perform trial-related activities. Each entry holds the name, role, delegated tasks, effective start and end dates, the delegate’s signature and the PI’s signature and date. ICH E6(R3) requires a record of delegation proportionate to the significance of the activity.
See a delegation go live, lapse and close, in one demo.
Thirty minutes, on your own study structure: a new study log from the task library, an evidence check, a PI signature from a phone, a permission switching on, an expiring GCP certificate raising a flag and a leaver closed off the same day. Then the same log opened as a monitor would see it.
