The Delegation of Authority Log: Who Did What, and Whether They Were Qualified To

At a glance

• The delegation log is the evidence that every study task was performed by someone the investigator authorized and judged qualified to do it.
• The investigator can delegate the work, but not the responsibility. Delegation transfers tasks, not accountability.
• Delegatees must be both appropriately qualified and adequately informed about the protocol and the investigational product before they act.
• The log has to agree with the Form FDA 1572 sub-investigator listing and with the CVs and training records. Inspectors read all three against each other.
• The depth of documentation is proportionate to the significance of the task, so the log is a real control, not a formality.

What the delegation log is, and what it proves

A clinical trial is run by a team, but the regulations hold one person answerable for it. The delegation of authority log is how that one person, the investigator, shows that each task was assigned to a named, qualified individual and performed under their oversight. ICH E6(R3) is explicit that delegation is allowed: the investigator may delegate trial-related activities to other persons or parties, and the investigator retains the ultimate responsibility and should maintain appropriate oversight (ICH E6(R3) §2.3.1). The log is the contemporaneous record of who was authorized for what, from when to when.

That last clause of §2.3.1 is the one teams under-read. Delegation moves the work; it does not move the accountability. The federal rule says the same thing from the US side: the investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations, and for protecting the rights, safety, and welfare of subjects (21 CFR Part 312 §312.60). You can delegate drawing the blood; you cannot delegate being the person FDA holds responsible if it was drawn wrong.

Qualified and informed, before they act

A name on a log is not enough. E6(R3) attaches two conditions to anyone the investigator delegates to. The investigator should ensure that persons or parties to whom trial-related activities are delegated are appropriately qualified and are adequately informed about relevant aspects of the protocol and the investigational product (ICH E6(R3) §2.3.2). “Appropriately qualified” is what the CV or training record behind each delegatee evidences. “Adequately informed” is what protocol training and the trial-specific onboarding evidence. A delegation log entry with no qualification trail behind it is an assertion, not proof.

This is why the start date on the log matters. A person should not be performing a delegated activity before the date they were trained and authorized for it. An entry that shows someone running procedures a week before their documented training is a finding, because it means a task was done by someone not yet shown to be qualified.

The record itself, sized to the task

E6(R3) requires the record and ties its depth to risk. The investigator should ensure a record is maintained of the persons and parties to whom trial-related activities have been delegated, and the documentation of delegation should be proportionate to the significance of the trial-related activity (ICH E6(R3) §2.3.3). Proportionate cuts both ways: a high-stakes activity like assessing eligibility or administering the investigational product warrants careful documentation; a trivial administrative task warrants less. The log is a control, not a bureaucratic reflex, so the effort follows the significance.

Where activities are delegated outside the site, the paperwork extends. Agreements made by the investigator or institution with service providers for trial-related activities should be documented (ICH E6(R3) §2.3.4). The principle is consistent: whoever does a trial activity, the chain from the responsible investigator to that actor must be documented.

It has to agree with the 1572 and the CVs

The delegation log does not live alone. It is one corner of a triangle with the Form FDA 1572 and the qualification records, and inspectors read the three together. Anyone running protocol procedures or collecting data who appears on the delegation log should also be accounted for on the 1572’s sub-investigator listing, and each should have a CV or training record that supports the qualification claim. When the three disagree, when the log shows a coordinator the 1572 never listed, or a delegatee whose training postdates their first delegated task, the discrepancy is the finding.

Inspection readiness is the point

The delegation log is one of the first documents an inspection reconstructs, because it answers the foundational question: was every task done by someone authorized and competent. FDA’s bioresearch monitoring program inspects clinical-investigator conduct with attention to exactly the failures a weak delegation log hides: if an inspector observes or suspects regulatory deviations that may affect data reliability or endanger subjects’ rights, safety, or welfare, the inspection escalates (FDA BIMO Compliance Program 7348.811, inspectional conduct). And the investigator’s duty to make the records available is explicit: the investigator and institution should permit monitoring and auditing by the sponsor and inspection by the appropriate regulatory authorities (ICH E6(R3) §2.3.5). A delegation log that is current, complete, and consistent with its supporting records is a quiet, strong answer to the first question an inspector asks.

The investigator supervises, and the log is the proof

Delegation does not dilute supervision; it documents it. The Form FDA 1572 commitments make the supervision duty explicit. By signing, the investigator commits to personally conduct or supervise the described investigation (21 CFR §312.53(c)(1)(vi)(c)), and to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about their obligations in meeting the investigator’s commitments (21 CFR §312.53(c)(1)(vi)(g)). The delegation log is where “I supervised” stops being an assertion and becomes a record. It names who acted under the investigator’s authority, for which tasks, across which dates.

That is why the log’s anatomy matters. A defensible log carries, at minimum, each delegatee’s name and role, the specific trial-related tasks delegated to them, the start date the delegation took effect, the end date when it stopped, and signatures, including the investigator’s, authorizing the assignment. Each column answers an inspection question. The task list answers “was this person allowed to do what they did.” The start date answers “were they authorized and trained before they did it.” The end date answers “who was responsible on the day a given entry was made.” A log with names and roles but no dated, task-by-task authorization cannot answer the questions that decide an inspection.

The proportionality rule from ICH E6(R3) §2.3.3 governs the depth of these entries, not their existence. Critical activities, such as eligibility assessment, consent, investigational product handling, and primary-endpoint data collection, earn precise, dated authorization; a one-off administrative task earns less. What no activity earns is silence: if a person performed a trial task, the chain from the responsible investigator to that person should be documented, and the log is where that chain is kept. This is also why the log is not a start-of-trial artifact you file and forget. As staff join, change roles, or leave, the log has to track them in real time, because an entry added retrospectively cannot honestly attest to who was authorized on the day the work was done.

Where teams get it wrong

• Treating it as a formality. The log is the proof that tasks were done by qualified, authorized people. Filling it casually defeats its purpose.
• Delegating before training. A start date that precedes documented training and authorization means an unqualified person performed a study task. Sequence the dates correctly.
• Letting it drift from the 1572 and CVs. The three must tell the same story. Inspectors cross-read them.
• Confusing delegation with transfer of responsibility. The investigator retains final responsibility regardless of what is delegated (§2.3.1, §312.60).
• One-size-fits-all documentation. Depth should be proportionate to the significance of the activity, not uniform.
• Backfilling the log. An entry added after the work was done cannot honestly attest to who was authorized on the day it happened. The log has to be contemporaneous, updated as staff and roles change.
• Reading supervision as hands-off. The investigator signs up to personally conduct or supervise the investigation. A log that lists delegatees but shows no evidence the investigator actually oversaw them describes abdication, not delegation.

A delegation log done well is a clean ledger of who was authorized to do what, from when, with the qualifications to back each entry, agreeing with the 1572 and the CVs. It is the simplest possible proof that the team running the trial was the team allowed to. None of this is busywork. The log is the artifact that converts a diffuse, multi-person effort into a chain of individual accountability the investigator can stand behind and an inspector can follow. When it is current, dated, qualification-backed, and consistent with its sibling records, it quietly closes the first and most basic line of inquiry an inspection opens. When it is stale or contradictory, it opens a dozen more, because every gap invites the question of who really did the work and whether they were ever allowed to.

Sources

• ICH E6(R3) Good Clinical Practice, version R3
• 21 CFR Part 312, Investigational New Drug Application (current as of 4/14/2026)
• FDA Compliance Program Guidance Manual 7348.811, Bioresearch Monitoring: Clinical Investigators (2020)