A delegation of authority (DoA) log is the site-level record that documents which trial-related tasks the principal investigator has delegated to which staff members, and for what dates. It is required by ICH E6(R2) Section 4.1.5, which obligates the investigator to maintain a list of appropriately qualified persons to whom significant trial-related duties have been delegated. This guide walks through an annotated DoA log template field by field so site staff and study coordinators can build or audit one correctly.
For the underlying definition and regulatory framing, see the Delegation of Authority (DoA) Log dictionary entry. This guide focuses specifically on the template structure: the columns a compliant log needs, how to complete each one, and the documentation gaps that most commonly surface in monitoring visits and FDA inspections.
Why a DoA log exists: the regulatory basis
ICH E6(R2) Section 4.1.5 places the delegation obligation on the investigator: significant trial-related duties may be delegated to appropriately qualified staff, but the investigator remains accountable for the conduct of the trial at that site. Delegation transfers performance of a task, not regulatory responsibility for the trial.
In the US, 21 CFR 312.53 and 21 CFR 312.60 reinforce the same principle from the sponsor-selection and investigator-conduct sides: the sponsor must select investigators qualified by training and experience, and the investigator is responsible for the trial’s conduct in accordance with the protocol. The DoA log is the operational instrument that makes delegation auditable — it is the document a monitor or FDA inspector checks first to confirm that whoever performed a given procedure was actually authorized to perform it, on that date.
The DoA log is a distinct document from the FDA Form 1572 (Statement of Investigator). The 1572 is a single pre-trial signed statement naming the principal investigator and listing subinvestigators, amended only for defined triggering events (e.g., a new subinvestigator with FDA-1572-listed responsibilities, a new protocol). The DoA log, by contrast, is a continuously maintained, task-level record covering every delegated staff member — not just subinvestigators — with per-task effective start and end dates. It is a companion to the 1572, not a duplicate of it.
Annotated template structure
A complete DoA log entry needs the following fields. Most sites maintain this as a single table, one row per delegated task per person (a person performing three delegated tasks appears on three rows, or one row with all three tasks listed, depending on the site’s template — either is acceptable as long as each task-level authorization and its dates are unambiguous).
1. Protocol / study identifier
The protocol number and short title, so the log is unambiguously tied to one study. Multi-study sites should never share a single undifferentiated log across protocols.
2. Site name and number
Required for multi-site trials so the sponsor/CRO can match the log to the correct site’s essential documents file.
3. Staff member name (printed)
Full legal name of the delegated individual, matching their CV and training records held in the site’s regulatory binder or Investigator Site File.
4. Role / title
The person’s role on the study team — e.g., Sub-Investigator, Research Coordinator, Research Nurse, Clinical Research Associate (site-employed, not the sponsor’s monitoring CRA), Pharmacist, Data Entry Staff. See the CASRAI guide to clinical trial study team roles for how these roles typically divide responsibility.
5. Delegated task(s)
The specific procedure(s) the person is authorized to perform — for example, “obtain informed consent,” “administer investigational product,” “perform physical exam,” “complete case report forms,” “conduct AE/SAE assessment.” This is the field most frequently cited in inspection findings: vague entries such as “all study procedures” or “per protocol” do not satisfy the requirement and are routinely flagged. Each task should be specific enough that a monitor can look at a source document and immediately check whether the person who performed it was authorized to.
6. Effective start date
The date delegation for that task begins — not the date the person joined the study team in general, but the date they became authorized for that specific task. A person may be added to the team before being delegated every task they will eventually perform.
7. Effective end date
The date delegation ends — role change, task reassignment, staff departure, or study closeout. An open (blank) end date is standard for currently active delegations; it should be filled in promptly when delegation ends, not backfilled months later.
8. Staff member’s signature and date
The delegated individual signs to confirm they have received and accepted the delegated task(s), typically alongside acknowledgment that they have reviewed the protocol and completed required training (GCP training, protocol-specific training) for that task.
9. Delegating investigator’s signature and date (principal investigator authorization)
The principal investigator — or, where local SOPs and the protocol allow it, a formally authorized sub-investigator acting on the PI’s behalf — signs to authorize the delegation itself. This signature is what converts the row from a staffing note into a regulatory authorization.
10. Initials/signature reference column
Many templates include a small initials or signature-specimen block cross-referencing each person’s full signature and initials as they will appear on source documents and case report forms — this lets a monitor match an initialed source note back to a named, delegated individual.
Where the completed log lives
The DoA log is an essential document under ICH E6(R2) Section 8 and is filed in the site’s Investigator Site File (and, in the sponsor’s copy, the Trial Master File) alongside the CVs, training records, and licensure documentation that support each delegated individual’s qualifications. A delegation entry with no corresponding qualification record in the file is itself a common finding — the log and the supporting CVs/training certificates need to agree, not just exist independently.
Delegation for sub-investigators specifically
A Sub-Investigator is named on the FDA Form 1572 but does not sign it; their delegated scope of work is documented on the DoA log, not the 1572 itself. In practice this means a site can add or adjust a sub-investigator’s specific delegated tasks by updating the DoA log without necessarily triggering a 1572 amendment — though adding an entirely new sub-investigator with 1572-listed responsibilities, or a new protocol, are 1572-amendment triggers under 21 CFR 312.53. Confirm the current sponsor/CRO SOP on this distinction, since practice on exactly which sub-investigator changes require a 1572 update can vary.
Common documentation errors monitors and inspectors flag
- Undelegated task performance — a procedure documented as performed by someone who is not on the log, or whose delegation for that task had already ended.
- Vague task descriptions — “all study procedures” or “per protocol” instead of enumerated, specific tasks.
- Stale logs — the log not updated promptly after a staffing change, role change, or departure, so it no longer reflects who is actually authorized to do what.
- Missing supporting qualification records — a delegated task with no CV, training certificate, or licensure documentation on file to support that person’s qualification for the task.
- Missing or late signatures — a task performed before the PI’s authorizing signature date, or before the staff member’s own acknowledgment signature.
Maintaining the log through the study lifecycle
Treat the DoA log as a living document, reviewed at minimum: at study start-up (see the CASRAI guide to study start-up in clinical trials), whenever staffing or roles change, at protocol amendment if the amendment changes required tasks or qualifications, and at each monitoring visit as a standing check item. A log that is only completed once at study start and never revisited is one of the most common gaps a monitor or inspector will surface.
Frequently asked questions
Who is authorized to sign a delegation on the DoA log?
The principal investigator authorizes delegations. Some sites, per local SOP and where the protocol/sponsor agreement permits, allow a designated sub-investigator to co-sign or authorize on the PI’s behalf, but the PI retains ultimate regulatory accountability for the trial’s conduct at the site regardless of who signs a given delegation line.
Does every study team member need to appear on the DoA log?
Only staff performing significant, trial-related, protocol-specified duties need a delegated entry — informed consent, study procedures, investigational product administration, AE assessment, and similar. Purely administrative support with no direct protocol-related task typically does not require a DoA entry, though site SOPs vary on where exactly that line is drawn; when in doubt, document it.
How often should the DoA log be updated?
Whenever a delegation changes — a new task assigned, a staff member’s role changed, or someone leaving the study team — not on a fixed calendar schedule. In practice, most sites also review it at every monitoring visit as a standing check.
What happens if a task is performed by someone not listed on the log for that task?
It is typically documented as a protocol deviation and is one of the most common findings in monitoring visits and FDA inspections. Adding the person’s delegation retroactively does not cure the deviation — the delegation must be authorized before the task is performed, and any gap is addressed through the site’s deviation/CAPA process, not by backdating the log.
Is the DoA log the same thing as the FDA Form 1572?
No. The 1572 is a single, pre-trial, PI-signed statement naming the PI and listing subinvestigators for an IND-regulated drug trial, amended only for specific triggering events. The DoA log is a continuously maintained, task-level authorization record covering every delegated staff member with per-task effective dates. See the FDA Form 1572 entry for the full comparison.
