Procedural readiness for first-in-human device trials: proctoring, simulation, dry runs and sign-off

The contract is signed, the ethics committee has approved the protocol and the devices cleared customs last week. Then the first patient is on the table, the delivery system is in the physician’s hands for the first time under live fluoroscopy, and the scrub nurse is opening packaging she has only seen in a slide deck. That’s the morning when a first-in-human (FIH) device study is most fragile, and it’s where the early protocol deviations come from.

I am Julio Martinez-Clark, CEO of bioaccess®. We run early feasibility and FIH device studies across Latin America for sponsors who plan to take the data to FDA. This page covers how I build procedural readiness before the first case: benchtop and simulation training, dry runs in the real room, device-placement training logs, proctor sign-off and a monitor check that ties it together. It also sets out what 21 CFR Part 812 actually asks for, and what it leaves to the sponsor. It sits next to our guide on foreign proctors and field engineers at FIH cases in Latin America, which covers the permits the visiting team needs to be in the room.

This is operator guidance, not legal or medical advice. The device’s instructions, the investigational plan and the site’s own credentialing rules always come first.

One-sentence answer

Before the first subject is enrolled, every person who will touch the investigational device should have practiced the procedure on a bench or simulator against written pass criteria, rehearsed the case in the actual procedure room with the actual team, had each training session recorded in a log tied to the device version and protocol version, and been signed off by a qualified proctor, and the monitor should have checked those records against the protocol steps before the site is activated.

What the evidence says about early cases

There is no single number for how many deviations happen in the first cases of a device trial, and I’d be careful with anyone who quotes one without a source. Two published studies are worth knowing, as long as you read them for what they measured.

• Deviations follow a learning curve. A retrospective analysis of the VALIANT trial (Taekman et al., Quality & Safety in Health Care, 2010) looked at 12,367 patients at 931 sites and found that protocol departures were more common for patients enrolled earlier at each site. In the authors’ words, compared with the 30th patient, the first had 47% more departures. Departures were also more common at sites that enrolled slowly. VALIANT was a drug trial in acute myocardial infarction, not a device study, but the pattern is the one every device sponsor sees: the first patients at a site carry the most risk of a departure from the plan.
• Training to a benchmark beats training for time. A randomized study in JAMA Network Open (Mascheroni et al., 2023) compared two simulation curricula for 30 novice cardiac device implanters performing a virtual cardiac resynchronization therapy implant. The group that had to demonstrate a predefined proficiency level before advancing completed 27% more procedural steps and made 73% fewer errors and 84% fewer critical errors than the group that received the same simulation training without the proficiency requirement. That was measured on a simulator, not in patients and not as protocol deviations, so it shouldn’t be quoted as a clinical trial deviation rate. What it does show is that how you gate training matters as much as whether you do it.

FDA’s draft guidance on protocol deviations (December 2024, non-binding and not yet final) draws the operational conclusion. It says sponsors should train investigators on the protocol to help them follow it, and should also train them to identify important protocol deviations. Its list of deviations FDA considers important includes implanting an incorrect device. It also notes that a high number of deviations at a site may suggest that more resources, such as staffing or training, are needed.

What 21 CFR Part 812 requires, and what it doesn’t

Part 812 doesn’t use the words “simulation” or “proctor,” and it doesn’t set a number of training cases. It does set the obligations that a training program has to satisfy, and an FDA reviewer or inspector will look for evidence of them.

• Qualified investigators. Under § 812.43(a), the sponsor must select investigators qualified by training and experience to investigate the device. Under § 812.43(c), the signed investigator agreement includes the CV and, where applicable, a statement of relevant experience with dates, location, extent and type. Under § 812.43(d), monitors must also be qualified by training and experience.
• Informed investigators. Under § 812.45, the sponsor must give every participating investigator the investigational plan and the report of prior investigations, which under § 812.27 covers the prior clinical, animal and laboratory testing of the device.
• Written monitoring procedures. Under § 812.25(e), the investigational plan includes the sponsor’s written monitoring procedures. Under § 812.46(a), a sponsor who finds an investigator not complying with the agreement or the plan must promptly secure compliance or stop shipments and end that investigator’s participation.
• Supervised device use. Under § 812.110(c), the investigator may let the device be used only with subjects under the investigator’s supervision, and may not supply it to anyone not authorized to receive it. That’s the basis for keeping the local investigator, not the visiting proctor, responsible for each case.
• Deviation records and approvals. Under § 812.140(a)(4), the investigator keeps the protocol with documents showing the dates of and reasons for each deviation. Under § 812.150(a)(4), a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency must be reported to the sponsor and the reviewing IRB as soon as possible, and no later than 5 working days after the emergency. Outside an emergency, changes in or deviations from the plan need the sponsor’s prior approval, and, if they may affect the scientific soundness of the plan or the rights, safety or welfare of subjects, FDA and IRB approval as provided in § 812.35(a).
• Data from outside the US. When data from a study run outside the US, such as an FIH study in Latin America, supports an IDE or a marketing submission, § 812.28(a)(1) asks for a statement that the study followed good clinical practice. Section 812.28(b) asks for a description of what the sponsor did to ensure it, including the investigators’ qualifications (b)(2), how the sponsor monitored the study and ensured it followed the protocol (b)(11), and how investigators were trained to comply with GCP and to conduct the investigation in accordance with the protocol (b)(12). That last item is the most direct regulatory hook for everything on this page: you will have to describe the training, so build it so it can be described.

In other words, the regulation tells you to use qualified people, monitor them and document deviations. Benchtop work, dry runs, logs and proctor sign-off are how I make “qualified by training and experience” something I can show to a reviewer rather than something I assert.

The readiness stack I use

1. Benchtop and simulation training with pass criteria

The physician’s general experience with similar procedures is the starting point, not the finish line. A novel delivery system, a new anchoring step or an unfamiliar sizing tool needs hands-on time before it goes near a patient.

• Train on the bench model, anatomical phantom or simulator the engineering team used to verify the device, with the same device configuration and instructions for use that the site will receive.
• Write the pass criteria before training starts: the steps that must be completed in order, the errors that fail a run, and the critical errors that fail it outright. Agree them with the lead investigator and the proctor.
• Train the whole team, not just the implanter. The scrub nurse prepares and hands off the device, the technologist sets up imaging, the anesthesia team needs to know the expected procedure time and the points where the patient must not move.
• Repeat until the criteria are met, and record each attempt. Hours spent at the bench prove attendance. A passed run against written criteria shows competence.

2. A dry run in the real room

The bench teaches the device. The dry run teaches the room. I schedule it at the site, in the procedure room where the first case will happen, with the people who’ll be on that case’s schedule.

• Walk the case from patient arrival to recovery. Who checks eligibility on the day, who confirms consent, who opens which package and when, where the device and its backups sit.
• Rehearse the handoffs on the sterile field and the imaging set-up for each step of the protocol.
• Rehearse what happens when something goes wrong: the bailout plan in the protocol, who decides to stop, which backup devices are open, how the case is documented.
• Check that the protocol-required measurements and images can actually be captured and saved the way the case report form expects.
• Run it in the team’s working language. In most of our sites that’s Spanish or Portuguese, and the training materials and procedure checklist should be in that language too, approved under the site’s document control.

Much of what a dry run catches isn’t clinical skill. It’s a missing extension cable, an imaging protocol that wasn’t loaded, a step in the case report form that nobody knew how to capture, or a device box stored where the sterile nurse can’t reach it.

3. Device-placement training logs

If it isn’t in the log, it didn’t happen. I set up the training log before training starts, so every session is recorded the same way. For each entry the log records:

• The trainee’s name and study role, and the trainer’s name.
• Date, location and training format (bench, simulator, dry run, proctored case).
• Device model and version, and the revision of the instructions for use and of the protocol used for training.
• The specific steps practiced, the pass criteria used and the result.
• Signatures of trainee and trainer.

The log goes into the investigator site file and the sponsor’s trial master file, alongside the delegation log. Two checks I run every time: nobody is delegated a device task on the delegation log without a matching training entry, and when the device or the instructions change, everyone affected is retrained and the log shows it. That record is also what lets the device receipt, use and disposition records under § 812.140(a)(2) match the people who actually handled the device. We cover the accountability side in our post on investigational device accountability in FIH studies.

4. Proctor sign-off

Proctoring is where the device’s most experienced operator watches, coaches and, when the plan allows it, steps in. Sign-off is the documented decision that a trainee can do the next case without that support, or with less of it.

• Define in advance who can proctor, what qualifies them and how many proctored cases the plan calls for. Write it in the training plan, not in an email.
• Use a sign-off form with the same criteria as the bench training: steps completed, errors, how the operator handled anything unexpected. The proctor signs, and the lead investigator acknowledges.
• Keep the roles clear. The local investigator stays responsible for the subject under § 812.110(c). The proctor advises and, where the local authorization and the plan permit, assists.
• Get the permits sorted before you book flights. In Colombia and Brazil, a foreign physician who takes part in a procedure needs an authorization requested by the host institution, and in Panama medicine is a profession reserved for nationals, with case-by-case routes. In Brazil the medical council asks for the request at least 30 days in advance. The details for Colombia, Brazil and Panama are in our foreign proctors guide.

5. The monitor closes the loop

Before site activation, the monitor checks the training log, the sign-offs and the delegation log against the protocol steps. After each of the early cases, I want a short debrief within days, not at the next routine visit: what deviated from the plan, why, and whether the cause was training, the device, the protocol or the room. My rule is that if the same deviation shows up twice, it gets a root-cause analysis and, if needed, retraining or a protocol clarification. FDA’s draft guidance, which is non-binding, recommends a root-cause analysis when similar deviations recur.

A readiness gate before the first subject

I don’t let a site enroll until these are true and filed:

1. Every person on the delegation log for a device task has a passed bench or simulator run against written criteria.
2. A full dry run has been done in the actual procedure room with the first-case team, and the issues it found are closed.
3. The training log is complete, signed, and tied to the current device version, instructions for use and protocol.
4. Proctor qualifications, the number of proctored cases and the sign-off criteria are written into the training plan.
5. Any visiting proctor or field engineer has the local authorization the country requires, or a documented reason none is needed.
6. The monitor has reviewed the training records against the protocol and signed off on activation.
7. The deviation reporting route is clear to the site team: what goes to the sponsor, what goes to the ethics committee and in what time frame.

This gate sits after the regulatory and ethics gate we describe in our cross-functional FIH readiness gate and the investigator selection steps in how we qualify FIH sites and investigators.

Common mistakes

• Treating a slide deck at the site initiation visit as device training.
• Training only the implanting physician and not the nurses, technologists and anesthesia team.
• Measuring training in hours instead of against pass criteria.
• Skipping the dry run because the team “does this procedure every week” with a different device.
• Training on one device version and shipping another, without retraining or a log entry.
• A proctor who arrives without the local authorization, so the first case moves or the proctor watches from outside the room.
• Waiting for the next scheduled monitoring visit to review the first case’s deviations.

How bioaccess® runs this

On our FIH and early feasibility studies, we build the training plan with the sponsor’s clinical and engineering team, translate and control the site materials, schedule the bench sessions and the dry run around the site’s procedure calendar, file the logs and sign-offs, and handle the visiting team’s local authorizations. Our monitors review the training records before activation and debrief the site after each of the early cases. If you are planning a first-in-human device study in Latin America, you can contact us.

FAQ

Does 21 CFR Part 812 require proctoring or simulation training?

Not by name. Part 812 requires investigators and monitors qualified by training and experience (§ 812.43), written monitoring procedures (§ 812.25(e)) and records of deviations (§ 812.140(a)(4)). Proctoring, simulation and training logs are the usual way sponsors meet and document those requirements for a novel device.

How many proctored cases should a site do?

There’s no regulatory number. It depends on the device, the procedure and how close it is to what the team already does. Set it in the training plan before the first case, and base sign-off on criteria rather than a count alone.

Can the visiting proctor be the operator?

Only if the plan allows it and the country authorizes it. Under § 812.110(c) the device can only be used with subjects under the investigator’s supervision, and in Colombia and Brazil a foreign physician needs a local authorization, requested by the host institution, to take part in a procedure. See our foreign proctors guide.

What happens if there’s a deviation in the first case?

Record it with the date and reason, as § 812.140(a)(4) requires. If it was an emergency deviation to protect the subject, notify the sponsor and the IRB as soon as possible and within 5 working days under § 812.150(a)(4). Any other deviation should have had the sponsor’s prior approval, so treat it as a compliance finding and report it the way the protocol and the ethics committee require. Then debrief the team before the next case and decide whether the cause calls for retraining, a protocol clarification or a change to the room set-up.

Sources: 21 CFR Part 812, §§ 812.25(e), 812.27, 812.28(a)(1) and (b)(2), (b)(11) and (b)(12), 812.35(a), 812.43(a), (c) and (d), 812.45, 812.46(a), 812.110(c), 812.140(a)(2) and (a)(4) and 812.150(a)(4) (eCFR, current as of October 2026); FDA, Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices, draft guidance for industry (December 2024); Taekman JM et al., “Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve,” Quality & Safety in Health Care, 2010 (doi:10.1136/qshc.2008.028605); Mascheroni J et al., “Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters,” JAMA Network Open, 2023;6(8):e2322750 (doi:10.1001/jamanetworkopen.2023.22750).