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Log Plug-and-play starting point Clinical & GCP

Log: Delegation of Authority (Site Delegation Log)

A plug-and-play site delegation of authority log for a clinical trial: who is delegated to do which trial tasks, from and to dates, PI authorisation, and the training that backs each delegation, with field definitions and a filled specimen.

Document type: Log

Read and copy the template below into your own quality system. It is a generic starting point for your own internal use, provided as is, with no warranty; see the Terms and License. Adopting it does not by itself create compliance.

This is a ready-to-use delegation of authority log for a clinical trial site. It records who the principal investigator has delegated each trial-related task to, that each person was qualified and trained before doing the task, and the dates the delegation was active. When an inspector asks “who did this, and were they allowed and trained to,” the delegation log plus the training records behind it is the answer. Replace every <<FILL: ...>> placeholder with your specifics and route it through your site filing. A filled specimen follows. Verify cited regulations against the current source. This is general guidance to adapt, not legal or regulatory advice.

FieldEntry
Study / protocol<<FILL>>
Site number / name<<FILL>>
Principal investigator<<FILL>>
Log version / page<<FILL>>

Delegated tasks legend

Define the task codes used in the log so a reviewer can read it without guessing. Adapt to your protocol.

CodeDelegated task
AInformed consent discussion and documentation
BEligibility assessment / medical decisions (qualified physician)
CInvestigational product dispensing / accountability
DSource documentation / eCRF entry
EAdverse event assessment and reporting
FSample collection / processing
GRandomisation / unblinding per protocol
<<FILL>><<FILL: add study-specific tasks>>

Delegation log

NameRoleDelegated tasks (codes)Qualified/trained confirmedFrom dateTo datePI signatureDelegate signature
<<FILL>><<FILL>><<FILL>><<FILL: Yes + training ref>><<FILL>><<FILL: or "ongoing">>
<<FILL>><<FILL>><<FILL>><<FILL>><<FILL>><<FILL>>

Field definitions

FieldFormatRequiredWhoWhen
Name / roletextYesCoordinatorOn delegation
Delegated taskstask codesYesPIOn delegation
Qualified/trained confirmedYes + referenceYesPI/coordinatorBefore task performed
From datedateYesPIOn delegation
To datedateYes (when ended)PIWhen delegation ends
PI signaturesignatureYesPIOn delegation and on change
Delegate signaturesignatureYesDelegateOn delegation

Rules

  • No one performs a delegated task before their From date, or after their To date.
  • The delegation must match what the person is qualified and trained to do; the training record has to predate the first performance of the task.
  • The PI signs to authorise each delegation and each change; changes are new dated lines, not edits over old entries.
  • Keep the log current throughout, not reconstructed before a monitoring visit or inspection.

Filled specimen

Illustrative, values invented. Study ABC-301, Site 04, PI Dr. L. Fernandes.

NameRoleDelegated tasksQualified/trained confirmedFromToPI sigDelegate sig
Dr. L. FernandesPrincipal investigatorA, B, C, D, E, GYes, CV + GCP 2026-04-302026-05-01ongoingsignedsigned
Dr. P. NairSub-investigatorB, EYes, CV + GCP 2026-05-052026-05-10ongoingsignedsigned
S. MehtaStudy coordinatorA, D, FYes, protocol + consent SOP 2026-05-062026-05-10ongoingsignedsigned
R. CostaPharmacistCYes, IP manual 2026-05-082026-05-12ongoingsignedsigned
T. AlvesCoordinator (temp)D, FYes, protocol 2026-06-152026-06-202026-07-31signedsigned

Reading it: when the monitor verifies participant 3012’s consent taken by S. Mehta on 2026-06-02, the log shows S. Mehta delegated task A from 2026-05-10 with consent-SOP training dated 2026-05-06, so the consent was taken by a delegated, trained person, which is exactly the acceptance criterion the consent checklist tests. T. Alves has a To date of 2026-07-31, so any eCRF entry by T. Alves after that date would be a finding.

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