Panel · Use case · Clinical Operations
Investigator Sites Rehearsal.
LiveStakeholder RehearsalRehearse a protocol amendment briefing to investigators with simulated site, safety, quality and coordinator voices.
Investigator Sites Rehearsal is a ready-made use case for Clinical Operations. It ships under the Stakeholder Rehearsal template.
For clinical operations leads. You get each simulated constituency's position, where they conflict, the objections with proposed responses and what each would need to move. The constituencies are simulated, not consulted. Claims are cited or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
How will a principal investigator, a study coordinator, a safety physician and a quality lead react when briefed on a protocol amendment that tightens visit schedules?
Who is simulated
Investigators and coordinators carry the workload of a visit schedule. ICH E6(R3) places responsibilities on sponsor and investigator alike, and the seats are briefed on it.
| Constituency simulated | What it is asked | What it works from |
|---|---|---|
| Principal investigator | Whether the amendment is clinically justified and what it does to patients’ burden.1 | ICH E6(R3) investigator responsibilities. |
| Study coordinator | Scheduling, staffing and the practical cost of tighter visits. | Site practice. |
| Safety physician | Whether the tighter schedule serves safety monitoring and what it needs. | Safety monitoring plans. |
| Quality lead | Deviation risk, training and documentation.1 | ICH E6(R3) and deviation practice. |
What the rehearsal does
Burden is the first objection. Sites will ask what the amendment costs them and whether they are compensated. The report lists the burden objections and a response for each.
Deviations rise with complexity. The quality seat expects more visit window deviations if the schedule tightens, and says how the sponsor would train and monitor. It asks whether each added visit is needed for the decision the trial serves.1,2
Engage in order. At Full depth the report suggests an order: the lead investigators first, then coordinators, so the plan is tested before it is announced.
Recommended length
Standard
Four constituencies are in the room. Standard depth gives each a seat and ends with what a rehearsal cannot tell you, in about four pages.
You can pick another length on the form. The other two stay available.
Assumptions the rehearsal checks
The rehearsal states the assumptions it makes about each constituency, and says what each gap limits. Examples for this meeting:
- Sites have staff to deliver the added visits.
- The safety rationale for the amendment is documented.
- Participants will accept the added visits.
Standards, guidance and sources
Frame
The decision practice behind the memo itself is on the template page.
What gets flagged
Any compensation claim not supplied by the sponsor, any site capacity assumption not checked with operations, and any objection no response was prepared for.
What arrives
- The question put, and who was simulated
- The stakeholder map
- Each constituency's position
- Where they conflict
- Objections and responses
- What each would need to move, and the order to engage
- What a rehearsal cannot tell you
What it will not do
The constituencies are simulated by AI specialists and are not the real people. The rehearsal prepares you for objections you can anticipate and does not predict the live room.
It does not replace a site feasibility survey.
It is not research with real stakeholders. The constituencies are simulated by AI specialists from stated sources, and they are not the real people.
It does not predict what the live room will say. It prepares you for the objections you can anticipate.
It does not script a response to be repeated. The responses are for you to test and to adapt.
References
- [1] International Council for Harmonisation. ICH E6(R3): Guideline for good clinical practice. Dates differ between listings; the guideline was not read in full.
- [2] International Council for Harmonisation. ICH E8(R1): General considerations for clinical studies. Not read.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Panel service
Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.
To edit a saved template, open New → Panel → From template, or the library rail on the service form.