Responsibilities
The site PI owns eligibility, consent, delegation, operator competency, scheduling coverage, source verification, and safety escalation. Delegated staff may perform these tasks within their qualifications; accountability stays with the PI.
Before enrollment
- Obtain local IRB approval or complete single-IRB reliance. No study procedure begins before approval.
- Name a research coordinator and a backup.
- Name credentialed TCUS operators and backup coverage for inpatient, outpatient, and urgent examinations. Professional role alone does not confer study competency.
- Document each operator's completed central-core training and reviewed demonstration acquisitions before independent study scanning.
- Confirm the site can perform the calibrated acquisition method (3D or tracked planes) required for volumetric endpoints. Under review — protocol appendix item 3 asks every site to confirm feasibility.
Surgical and eligibility decisions
- Implant selection and surgery remain clinical decisions. An implant is never placed or enlarged solely to obtain research eligibility.
- Confirm the index surgical indication is SDH. Patients operated on primarily for intracerebral, epidural, or subarachnoid hemorrhage are not eligible.
- Document window size, location, implant model, and accessibility from operative and device records; confirm at screening. The usable aperture must be ≥ 2.0 cm. A 14 mm window is ineligible; a nominal 2 cm cover does not qualify if fixation reduces the usable aperture; separate smaller windows cannot be added together.
- For bilateral SDH, identify each side and window separately.
- Document burr hole cover placement location. Finalizing 10/29
Consent
- Obtain written informed consent from the patient or a legally authorized representative. Surrogate consent may be used early postoperatively; patient consent is obtained when capacity returns.
- Make clear the ultrasound is additional, all standard imaging still occurs, and participation does not affect care.
During the study
- Confirm each TCUS/CT-MRI pair meets the permitted interval and stability requirements (see Patient Timeline).
- Clinical imaging and care take priority over every study procedure. No treatment decision is based solely on research TCUS.
- Serve as, or designate, the site clinician who receives urgent bedside findings from the operator and contacts the treating team immediately.
- Verify clinical source data entered by the coordinator; resolve clinical and eligibility queries from the data manager.
- Assess every adverse event for severity and relatedness. Report SAEs and unanticipated problems to the IRB on its timeline, and to the manufacturer or regulators where required.
- Serve as an investigator reviewer when adjudication is triggered (TCUS/CT-MRI discordance, or CT/MRI changes management despite a reassuring TCUS).
- Participate in monthly study team safety reviews and IRB continuing review.
Before CNS
Review the protocol draft for anything another site PI would immediately flag. Minor edits are not needed this round.