14.3 Delegation, Qualifications and Task Authority
Key Takeaways
Investigator oversight remains when qualified staff perform delegated activities.
Delegation documentation should be proportionate to the work.
A late log entry requires investigation of actual authorisation, training and performance dates.
Delegation, Qualifications and Task Authority
For example, a coordinator may transcribe a documented assessment using their own authorised account. That differs from independently making a medical causality decision outside their competence or signing as an investigator. Review who made the assessment, when they reviewed the information, and whether the reported data reflect that decision. A late signature may expose an oversight gap; it does not prove that no clinical review occurred, so investigate the evidence.
The Delegation of Authority (DOA) Log & The Non-Delegable Principle
Because a Principal Investigator cannot personally perform every clinical measurement, pharmacokinetic blood draw, and data entry across dozens of trial participants, tasks are delegated to qualified investigative site personnel. A common documentation tool for this process is the Site Delegation of Authority (DOA) Log (frequently titled the Site Signature and Delegation of Responsibilities Log).
The Cardinal Principle of Site Oversight
Important
The Non-Delegable Principle: The Principal Investigator may delegate the performance of specific study-related tasks to qualified, trained individuals. However, the Principal Investigator CANNOT delegate ultimate legal, regulatory, and ethical responsibility for trial conduct, subject safety, and data integrity. The PI remains fully accountable for all actions performed by delegates.
Documenting delegation proportionately
Maintain evidence identifying the person, delegated activity and relevant period, with qualifications and training appropriate to the work. The investigator retains oversight. A delegation log is a common tool, but E6(R3) uses proportionate documentation and does not require every routine clinical-care activity to appear on one rigid sponsor form.
Authorise and train staff before they perform trial-specific activities. If an entry was added late, determine whether authorisation, qualifications and training actually existed at the time. Record the facts and current correction date; never backdate. The risk differs between missing paperwork for an already qualified routine activity and an untrained person making a restricted trial decision. Avoid treating a missing log signature as automatic proof of fabrication or trial-wide invalidity.
When responsibilities end or change, update delegations and system access. Verify coverage during leave and turnover so safety reports, review of urgent results and participant communication remain assigned. Training evidence should demonstrate the right person's understanding of the relevant protocol version and task; attendance alone may be inadequate for a specialised rater or product procedure.
Verifying Site Qualifications and Regulatory Documentation
A central responsibility of the CRA during pre-study qualification visits, site initiation visits, and routine monitoring is auditing site qualifications. The monitor must verify:
Qualifications, training and technical capability
Review current CVs or equivalent evidence, relevant professional permissions and restrictions, and task-specific competence. A universal two-year CV expiration or three-year GCP certificate renewal is not an ICH requirement. The investigator and institution should apply relevant regulatory and sponsor/institutional requirements and retain appropriate evidence.
Protocol and system training should address the person's responsibilities before affected activities. Changes require information/training appropriate to their impact. A new rater scale can require specialised preparation; a corrected phone number ordinarily does not require the same curriculum. Confirm understanding and practical competence rather than collecting attendance signatures alone.
Laboratories and technical services should have appropriate quality evidence, methods and reference ranges for their role. The particular accreditation or licence depends on the jurisdiction and service. Verify that staff have the information needed to interpret results at the relevant time. If ranges change, establish the effective period and assess affected decisions rather than assuming all historical results must be recalculated.
Matching tasks to competence and authority
| Activity | Key verification question |
|---|---|
| Medical care and eligibility decisions | Is the person appropriately qualified, permitted under applicable requirements and delegated where appropriate? |
| Consent discussion | Is the designee qualified and trained under the approved consent process? |
| Product management | Is the person permitted to handle/dispense it and trained on the product instructions? |
| Specimen collection or processing | Are qualifications, task training and necessary facilities documented? |
| Data entry and query response | Is access attributable and consistent with delegation and the documented workflow? |
| Investigator endorsement | Did an authorised investigator personally review and endorse the data under their own identity? |
Delegation must reflect real work, not a form signed to excuse unauthorised activity later. A sponsor monitor can explain a discrepancy and request clarification but should not take over site medical decisions or impersonate site staff.
Onboarding a replacement team member
When a coordinator joins mid-study, identify the activities they will perform and the active protocol, system and manual versions. Verify relevant qualifications and training before those tasks begin, and establish access under the person’s own identity. Review coverage for urgent results and reports while the replacement is learning the workflow. A predecessor’s certificates and shared account cannot establish the new person’s competence or attribution. Document actual training and authorisation dates and verify the first relevant activities under the oversight plan; do not backdate the log to the previous employee’s departure.
Official sources
Checked October 18, 2026: ICH E6(R3), Principles and Annex 1, ACRP CCRA Exam Content Outline.
A delegation entry was recorded late. What should be established before drawing conclusions?
Assume a late signature proves criminal intent.
Whether appropriate authorisation, qualifications and training existed when the activity occurred.
Assume the activity never occurred.
Backdate the log to avoid a finding.
Sections you finish are checked off in the contents.