Free template

Delegation of authority log template

A free delegation log for research sites. It records which study tasks the investigator has delegated to each staff member, from when, and the PI's sign-off.

No sign-up needed to download.

Why sites keep one.

ICH E6 expects the investigator to keep a list of appropriately qualified people to whom significant trial-related duties are delegated.

Monitors and inspectors compare the log with who actually performed each task, so start and end dates matter as much as the task list.

Tips

  • Add a task key at the top: 1 Informed consent, 2 Eligibility, 3 Physical exam, 4 AE assessment, 5 IP dispensing, 6 eCRF entry, 7 Specimen handling, 8 Query resolution.
  • Never delegate a task before training for it is documented.
  • When someone leaves, add an end date; do not remove the row.

What goes in each column

Staff name
Full printed name
Role
e.g. Sub-investigator, CRC, pharmacist
Delegated tasks
Task codes from the key, e.g. 1, 3, 7
Start date
First day authorized (DD-MMM-YYYY)
End date
Last day authorized, or blank if current
Staff signature
Signature of the staff member
Staff initials
Initials used on source documents
PI initials
Investigator's initials authorizing
PI date
Date the PI signed (DD-MMM-YYYY)

When this record is needed

Use delegation of authority according to the protocol, sponsor requirements and your site procedures. ICH E6(R3) describes investigator oversight and essential records; 21 CFR 312.62 addresses applicable investigator records and retention. Neither source mandates this exact downloadable layout for every study.

Agree on the record’s owner, update frequency and filing location before using the template. A form should help reconstruct what happened, not create a parallel tracker with conflicting information. Keep original supporting records and use the approved study convention for identifiers and dates.

Filled example, not real study data

A sample coordinator is authorized for source entry from 27 October 2026 after the required training. The row records the task code, start date, staff signature reference and investigator authorization date. It does not backdate permission to cover earlier work.

The example is deliberately limited. Do not put live identifiers into a public download preview or email request. Adapt the field explanations with your study team, then check that an independent reviewer can identify the responsible person, event, date and supporting evidence without an oral explanation.

Filled example, not real study data
Sample staffRoleTaskStart dateAuthorization
Sample CoordinatorCoordinatorSource entry27-Oct-2026Staff / PI review references

Review risks before monitoring

Common review risks include missing dates, unclear task or criterion references, signatures that cannot be tied to a person, and entries that contradict the source record. These are practical checks, not a claim about the frequency of findings in an inspection dataset. Review one row against its supporting evidence before treating the log as ready.

Do not overwrite an earlier entry to make the file look current. Record changes using your site’s correction procedure and retain the earlier information. A late explanation does not erase the original issue or change whether a deviation must be reported. Confirm reporting requirements with the protocol, sponsor and IRB.

How Kyros Trials handles the related work

The delegation workflow keeps study-related staff responsibilities and review records connected. Confirm training and authorization before a staff member performs the task; electronic storage alone does not authorize a person.

The template remains a free planning and record-format aid. Electronic workflows add record context and access controls, but your team still owns intended-use review, training, investigator oversight and retention. Inspect the corresponding workflow in a demo and compare it with your site’s procedure before switching from paper.

Questions people ask.

Answers to the questions research sites ask most.

Still have questions? Book a demo

Keep these logs in Kyros Trials instead.

Walk through your visit schedule, source records and sponsor billing with our team.

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