Delegation of Authority (DoA) Log

A Delegation of Authority (DoA) log is the site-level record documenting which trial-related tasks a Principal Investigator has authorized named study-team members to perform, and when. Required under ICH E6(R2) Section 4.1.5, each entry is signed by both the delegate and the PI, and it is one of the documents FDA inspectors and monitors check most often.

Regulatory Basis

ICH E6(R2) Section 4.1.5 requires the investigator to maintain a list of appropriately qualified persons to whom significant trial-related duties have been delegated. Under 21 CFR 312.53 and 312.60, the PI retains overall responsibility for the conduct of the trial at the site even when specific tasks are delegated — delegation transfers the performance of a task, not the PI’s accountability for it. The DoA log is the operational document sites use to evidence compliance with both: it is where the who/what/when of every delegation is captured in a single, auditable place.

What a Compliant DoA Log Actually Contains

A DoA log that will hold up under monitoring or inspection review includes, at minimum:

• Named individuals, not job titles alone — every co-investigator, sub-investigator, Clinical Research Coordinator (CRC), research nurse, or research pharmacist who performs trial-related work.
• Specific delegated tasks — stated concretely (e.g., ‘obtaining informed consent,’ ‘administering investigational product,’ ‘source documentation,’ ‘adverse event assessment,’ ‘IP accountability’), not a catch-all like ‘study procedures.’
• Evidence of qualification — the log itself typically just references that training/licensure/CV records exist; the underlying documents (current CV, medical license where applicable, protocol- and GCP-training certificates) are filed alongside it in the Investigator Site File (ISF).
• Signatures or initials — both the delegate (acknowledging the assignment) and the PI (authorizing it).
• Start and end dates — the specific period each delegation was in effect, updated as staff join, change roles, or leave the study — not just a single trial-wide date range.

Where It Lives and What It Relates To

The DoA log is a required element of the Investigator Site File (ISF), the site-level counterpart to the sponsor’s Trial Master File (TMF). It is distinct from FDA Form 1572: the 1572 is a pre-trial statement, signed once (and re-signed only for defined triggering events such as a new protocol), that names the PI and lists subinvestigators who will assist — it does not specify individual task-level authorizations or track ongoing staffing changes the way a DoA log does. The log is typically established or reviewed at the Site Initiation Visit (SIV), before the site begins enrolling subjects, and is then maintained as a living document for the trial’s duration.

Common Inspection and Monitoring Findings

The DoA log is one of the most frequently cited sources of findings in FDA inspections and sponsor audits because it is easy to check against other records and easy to let lapse operationally. Recurring patterns include:

• Undelegated performance — source documentation, informed consent, or an adverse event assessment performed or signed by a staff member who is not listed on the log at all, or whose delegation for that specific task had not yet started (or had already ended) on the date the task was performed.
• Vague task descriptions — entries like ‘all study procedures’ or ‘per protocol’ that cannot be checked against a specific action, because they don’t specify what was actually authorized.
• Stale logs — a log that has not been updated despite documented staffing changes, so it no longer reflects who is actually working on the trial.
• Missing qualification support — a delegated task with no corresponding training record, CV, or licensure documentation in the ISF to establish that the person was appropriately qualified for what they were delegated.

Because the log is cross-checked against source documents and consent records rather than reviewed in isolation, a gap here can call into question the reliability of the data or consent process it is meant to support — which is why sites and monitors treat it as a routine, recurring check rather than a one-time setup task.

Frequently Asked Questions

Who is responsible for maintaining the DoA log?

The PI is ultimately responsible for the log’s accuracy and currency, since delegation transfers the performance of a task, not the PI’s regulatory accountability for the trial’s conduct at that site. In practice, a CRC or regulatory coordinator often maintains the log day to day, with the PI reviewing and signing off on additions and changes.

Does every study team member need to be on the DoA log?

Only those performing what ICH E6(R2) 4.1.5 describes as significant trial-related duties — consent, protocol-specified assessments, IP administration or accountability, source documentation, safety reporting, and similar tasks that affect subject safety or data integrity. Purely administrative support with no trial-specific judgment involved is not typically delegated on the log, though many sites include it anyway for completeness.

How is the DoA log different from FDA Form 1572?

Form 1572 is a single signed statement naming the PI and listing subinvestigators for an IND-regulated drug trial, executed before the site begins and amended only for specific triggering events. The DoA log is a task-level, continuously maintained record covering every delegated staff member (not just subinvestigators) and every specific task, updated throughout the trial as staffing changes.