Field notes
Trained first, or delegated first? What an inspector actually checks
The question coordinators ask, what FDA, ICH E6(R3) and the MHRA actually require, and the day-of-visit check that proves you are covered.
Short answer: both dates have to be on or before the first day the person performs the task, and training should come first. The delegation date is the day the PI signed the row, not the day you typed it. If the training log says Sept 15, the PI signed the delegation log Sept 16, and the person drew their first study blood on Sept 22, you are fine. If the blood draw was Sept 14, no paperwork afterward fixes it. The rest of this post is where that comes from, how a monitor checks it on a visit day, and what to do when someone new starts mid-study.
The question as coordinators ask it
It comes up the week a new person starts. The PI is in clinic, the new MA is ready to take vitals, and someone asks: does the delegation log date have to be after the training date, or just before they do anything? If the PI signs today and the training certificate says tomorrow, is that a finding?
The threads where coordinators argue this out land in the same place every time: trained and delegated, both dated before the task, one of them quoting an FDA inspector who said both need to be in place first. That matches the rules.
What the regulations actually require
FDA. The 2009 guidance Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects says the investigator "should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task," and should keep a list of the people delegated significant duties that "should also describe the delegated tasks, identify the training that individuals have received that qualifies them to perform delegated tasks (e.g., can refer to an individual's CV on file), and identify the dates of involvement in the study." Names, tasks, training, dates: that is your delegation log.
ICH E6(R3). Section 2.3 of the final guideline says the investigator may delegate but "retains the ultimate responsibility and should maintain appropriate oversight" (2.3.1), should ensure delegates "are appropriately qualified and are adequately informed about relevant aspects of the protocol, the investigational product(s) and their assigned trial activities" (2.3.2), and "should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities" (2.3.3). R3 adds that ordinary clinical-practice activities may not need delegation documentation, which matters for the standard-of-care question in who can do what at a study visit.
MHRA. The UK inspectorate says the timing part out loud. Its GCP Guide, quoted on the MHRA's GCP forum, says the log should be "signed and dated by the PI prior to the activity being undertaken by the individual. It is not acceptable for the PI to simply sign-off the delegation log at the end of the trial." In the same thread a monitor names the two problems found at close-out again and again: staff performing tasks for weeks before they were delegated, and staff never on the log at all.
None of the three say the delegation date must be after the training date. They say the person must be qualified and trained, and the delegation documented before the work. The order between the two dates is about defensibility, not regulation.
The practical answer, and why training first
Both dates on or before the first task. Training first.
The PI's signature on the delegation log is an attestation: I have judged this person qualified to do these tasks on this study. If the signature is dated the 16th and the protocol training the 17th, the PI attested to training that had not happened. A monitor may let that pass if the first task came later; an inspector reading the binder cold will ask. The NIAID Division of AIDS manual states it plainly for its sites: the PI records delegated duties "only after completion of all protocol-specific training" (DAIDS SCORE manual, 2023). Every sponsor's monitor will nod at it.
Two details that trip people up:
- The delegation date is the PI's signature date. Not the day you filled in the row. A start date of Sept 16 with a PI signature on the 18th says the PI authorized something two days before signing. Leave the start date blank until the PI signs.
- The training has to be for this task. A GCP certificate is not protocol training. The entry that backs a delegation row is the protocol-specific one.
The check a monitor runs on the day of a visit
Take the sample schedule I use on this site: Subject 012 randomized 2026-09-08, so Week 4 is Day 28, target 2026-10-06, window 10-03 to 10-09. She comes in on the 6th for vitals, a 12-lead ECG, a urine pregnancy test, safety labs, an AE review and study drug dispensing (the order is its own post: what happens at Week 4, in what order).
For every line, a monitor reads the source for whose initials are on it, then asks four questions:
- Is this person on the log for this task? Not "on the log": on the log for vitals, or for ECG, or for dispensing.
- Is their start date on or before 2026-10-06?
- Is their end date blank, or after 2026-10-06?
- Is the qualification behind it current on 2026-10-06: protocol training documented, GCP and license unexpired, CV within the sponsor's window?
Four yeses per line, six lines, and the visit is clean. A monitor needs ten minutes per subject; you need ninety seconds, if you already know who is doing what.
The three findings this produces
Task performed before delegated. The initials on the vitals are the new MA's, dated 2026-09-14; her row is signed 2026-09-16. Two days of undelegated vitals on every subject who came through. The most common finding, because the easiest to cause: the person started before the PI got to the binder.
Delegation without documented training. The row is signed and the dates line up, but nothing in the training file shows protocol training before the start date. The log says qualified; the file cannot prove it.
Lapsed qualification. Right on day one, then time passed. GCP training is typically refreshed every three years (DAIDS requires it "before delegating staff to any clinical trial-specific duties, and every three years thereafter"; most sponsors follow that cadence, a few want two). CVs are commonly re-signed every two years. A license renews on the state's schedule, not the study's. Someone validly delegated in March can be unqualified by October without anyone changing a row.
When someone new starts mid-study
The order of operations, which is also the order the paper should be dated:
- Qualifications on file. Signed and dated CV, license copy if the role needs one, GCP certificate checked against the sponsor's window.
- Training. Protocol training on the study-specific training log, any equipment or vendor training the tasks need (ECG machine, IWRS, ePRO), site SOPs. Dated and signed.
- PI signs the delegation log. The row lists the specific tasks; both sign and date. Start date is the PI's signature date.
- They may perform. From this date forward, their initials can go on source for the delegated tasks.
Until step 3 is done, they shadow: in the room, watching, not touching the subject, the device, the drug or the source. A trained MA watching you take vitals for a week is awkward. The finding is worse. If the PI is hard to pin down, bring the log and the training file together, so signature and evidence happen in the same sitting.
Who is usually delegated what
Typical, not required. The protocol can specify qualifications (FDA is explicit that a protocol requiring a physician for physical exams overrides state law allowing a PA), your PI decides who they trust, and state scope-of-practice law sets the floor.
| Task | Usually delegated to | Notes |
|---|---|---|
| Vital signs | CRC, MA, RN | Protocol may require a position or rest period |
| Phlebotomy | CRC, MA, RN, phlebotomist | State law and site policy on who may draw |
| 12-lead ECG | CRC, MA, RN | Machine training documented; interpretation stays with an investigator |
| Urine pregnancy test | CRC, MA, RN | Point-of-care testing may need a CLIA waiver on file |
| IP dispensing and accountability | CRC, pharmacist, RN | Some protocols restrict to pharmacy |
| AE assessment (severity, causality) | PI, sub-I only | FDA lists AE evaluation among tasks found inappropriately delegated |
| Eligibility confirmation | PI, sub-I only | Coordinators collect; an investigator confirms and signs |
| Informed consent | PI, sub-I; CRC where protocol and IRB allow | The consent discussion is the delegated act, not just the signature |
Your PI's column may differ; fine, as long as the log says so and the training file backs it.
Where the run sheet comes in
The window tells you when Subject 012 has to be seen, and nothing about who may do each line once she is in the chair. A visit run sheet that names, per procedure, the person delegated to it on the signed log, with certification status beside the name, turns the monitor's four questions into a glance the morning of the visit. Vitals: the MA, delegated since Sept 16, GCP good through 2028. ECG: you. AE review: Dr. K. Anything red, you swap before the subject arrives instead of explaining after. That is the whole check on a well-run day, and what I wish I had had the year the log lived in a binder, the schedule in a spreadsheet, and I hoped they agreed.