SIV Report

Written on 10/11/2023

Mike Halder

CTMS Site Initiation Visit (SIV) Annotated Report Specification

Document Version: 1.0 | System Configuration: Revision B, 10 June 2026 | Primary Target System: Clinical Trial Management System (CTMS)

1. Visit Information

Field Name	Entry Type	Value / System Instruction / Default
Study Name	Auto-populate	CTMS: PHILFIRST
Protocol Number	Auto-populate	CTMS: CL1108390
Protocol Version	System-configured	Revision B, 10 June 2026
Site Number	Auto-populate	Derived from CTMS Site Record
Site Name	Auto-populate	Derived from CTMS Site Record
Principal Investigator	Auto-populate	Derived from CTMS Site Record
Visit Date(s)	Auto-populate	Derived from CTMS Visit Schedule
Visit Method	CRA Manual Selection	On-site Remote Hybrid
CRA/Monitor	Auto-populate	Derived from CTMS User Profile
SIV Training Material Version/Date	CRA Manual Entry
Visit Summary	CRA Manual Entry

CRA Annotation (System Guidance):
For remote or hybrid visits, briefly document any materials or technology used to conduct the visit, and confirm how physical documents/signatures were verified.

2. Personnel Present

Name	Role	Attendance Status	Comments
		Present Absent Partial

3. SIV Checklist Requirements

A. Protocol and Study Design

ID	CTMS Question	Checklist Response	CRA Guidance / Comment Prompt	Comment Rule	Action Item Trigger
A01	Were site personnel trained on Protocol CL1108390, Revision B dated 10 June 2026?	Yes No N/A	Record training date, trainer, attendees, and training-slide version.	Required for No or N/A	Recommended for No
A02	Were the study objective and investigational purpose reviewed?	Yes No N/A	Confirm the site understands that PHIL™ is compared with Onyx LES, each as an adjunct to surgical evacuation.	Required for No or N/A	Recommended for No
A03	Was the prospective, randomized, controlled, open-label, blinded-endpoint design reviewed?	Yes No N/A	Confirm understanding of the PROBE design.	Required for No or N/A	Recommended for No
A04	Were both randomized treatment arms and the 1:1 randomization ratio reviewed?	Yes No N/A	Investigational arm: surgical evacuation plus PHIL™ MMAE. Control arm: surgical evacuation plus Onyx LES MMAE.	Required for No or N/A	Recommended for No
A05	Were planned enrollment and site enrollment limits reviewed?	Yes No N/A	Up to 350 subjects at up to 40 sites. No site may randomize more than 20% of the total.	Required for No or N/A	Recommended for No
A06	Were the primary effectiveness and safety endpoints reviewed?	Yes No N/A	Record any endpoint definitions requiring clarification.	Required for No or N/A	Recommended for No
A07	Were the secondary endpoints and follow-up through 180 days reviewed?	Yes No N/A	Include deaths, neurological events, device/procedure-related SAEs, and retreatment.	Required for No or N/A	Recommended for No
A08	Did site personnel demonstrate adequate understanding of the study design?	Yes No N/A	Summarize any knowledge gaps or additional training required.	Required for No or N/A	Recommended for No

B. Screening, Consent, and Eligibility

ID	CTMS Question	Checklist Response	CRA Guidance / Comment Prompt	Comment Rule	Action Item Trigger
B01	Was the site’s process for identifying and pre-screening potential subjects reviewed?	Yes No N/A	Briefly describe referral sources and responsible personnel.	Required for No or N/A	Recommended for No
B02	Were screening-log requirements reviewed?	Yes No N/A	Confirm reasons for exclusion will be recorded to the extent feasible.	Required for No or N/A	Recommended for No
B03	Were the point of enrollment and screen-failure definition reviewed?	Yes No N/A	Enrollment occurs when the study-specific ICF is signed. A randomized subject cannot be classified as a screen failure.	Required for No or N/A	Recommended for No
B04	Was the informed consent process reviewed?	Yes No N/A	Confirm use of the current IRB/EC-approved ICF, appropriate signatures and dates, adequate discussion time, and provision of a signed copy.	Required for No or N/A	Recommended for No
B05	Were LAR and impartial-witness processes reviewed, where applicable?	Yes No N/A	Note applicable site procedures.	Required for No or N/A	Recommended for No
B06	Were all inclusion and exclusion criteria reviewed?	Yes No N/A	Record any criteria requiring additional clarification.	Required for No or N/A	Recommended for No
B07	Was the site’s eligibility-confirmation process reviewed?	Yes No N/A	Confirm investigator documentation before randomization.	Required for No or N/A	Recommended for No
B08	Was baseline clinical-assessment timing reviewed?	Yes No N/A	Assessments should be completed within 24 hours of randomization.	Required for No or N/A	Recommended for No
B09	Were baseline imaging requirements reviewed?	Yes No N/A	CT/MRI within 72 hours before the first procedure. CT slice thickness must be less than 5 mm for hematoma measurement.	Required for No or N/A	Recommended for No
B10	Was target cSDH designation reviewed?	Yes No N/A	Confirm unilateral and bilateral target-side selection.	Required for No or N/A	Recommended for No
B11	Was the surgery-before-consent scenario reviewed?	Yes No N/A	Consent and randomization must occur before MMAE. MMAE must occur within 7 days of surgery and during the same hospitalization.	Required for No or N/A	Recommended for No

C. Randomization and Blinding

ID	CTMS Question	Checklist Response	CRA Guidance / Comment Prompt	Comment Rule	Action Item Trigger
C01	Was the requirement to confirm eligibility before randomization reviewed?	Yes No N/A	Confirm the site has a process preventing premature randomization.	Required for No or N/A	Recommended for No
C02	Was the requirement to randomize before MMAE reviewed?	Yes No N/A	Applies whether surgery occurs before or after randomization.	Required for No or N/A	Recommended for No
C03	Was the IWRS/randomization process reviewed?	Yes No N/A	Record trained users and any pending access.	Required for No or N/A	Recommended for No
C04	Were allocation-concealment expectations reviewed?	Yes No N/A	Treatment assignment remains concealed until generated by the randomization system.	Required for No or N/A	Recommended for No
C05	Was the open-label nature of treatment reviewed?	Yes No N/A	Subjects and treating investigators will know treatment assignment.	Required for No or N/A	Recommended for No
C06	Were blinded endpoint-assessment requirements reviewed?	Yes No N/A	Confirm protocol-required mRS/RFA and cSDH symptom assessments are performed by a blinded assessor.	Required for No or N/A	Recommended for No
C07	Was a qualified blinded independent assessor identified and trained?	Yes No N/A	Record the assessor and any pending training.	Required for No or N/A	Recommended for No
C08	Was the process for maintaining assessor blinding reviewed?	Yes No N/A	Describe separation from procedure reports, treatment assignment, and unblinded discussions.	Required for No or N/A	Recommended for No

D. Study Procedures and Follow-Up

ID	CTMS Question	Checklist Response	CRA Guidance / Comment Prompt	Comment Rule	Action Item Trigger
D01	Was the index procedure identified as MMAE?	Yes No N/A	Confirm all randomized subjects also undergo surgical evacuation.	Required for No or N/A	Recommended for No
D02	Was timing of MMAE relative to surgical evacuation reviewed?	Yes No N/A	MMAE should occur as soon as clinically feasible after randomization.	Required for No or N/A	Recommended for No
D03	Was the 7-day and same-hospitalization requirement reviewed?	Yes No N/A	Applies when surgery occurs before MMAE.	Required for No or N/A	Recommended for No
D04	Were permitted surgical techniques and the requirement to preserve the MMA reviewed?	Yes No N/A	If full or mini-craniotomy is performed, the MMA must remain intact.	Required for No or N/A	Recommended for No
D05	Were key MMAE procedural requirements reviewed?	Yes No N/A	Include preferred femoral access, DMSO-compatible microcatheter, target branches distal to the foramen spinosum, and assigned embolic agent.	Required for No or N/A	Recommended for No
D06	Was the restriction on adjunctive target-vessel embolization devices reviewed?	Yes No N/A	Other embolic devices are not permitted for target-vessel embolization.	Required for No or N/A	Recommended for No
D07	Was the Schedule of Events reviewed?	Yes No N/A	Use final protocol Table 4.	Required for No or N/A	Recommended for No
D08	Was the within-36-hours post-surgery assessment reviewed?	Yes No N/A	Adverse events, concomitant medications, and CT/MRI.	Required for No or N/A	Recommended for No
D09	Were the 48-hour visit requirements reviewed?	Yes No N/A	±6 hours. HIT-6 should be completed before pain medication and before early discharge when applicable.	Required for No or N/A	Recommended for No
D10	Were discharge assessments reviewed?	Yes No N/A	cSDH symptoms, mRS/RFA, adverse events, and medications.	Required for No or N/A	Recommended for No
D11	Were the 30-, 90-, and 180-day visits and visit windows reviewed?	Yes No N/A	30 days ±7 days; 90 days ±4 weeks; 180 days ±6 weeks.	Required for No or N/A	Recommended for No
D12	Was the follow-up visit-window anchor reviewed?	Yes No N/A	Windows are calculated from completion of the second procedure.	Required for No or N/A	Recommended for No
D13	Were retreatment-assessment requirements reviewed?	Yes No N/A	Required assessments should be completed before retreatment whenever possible.	Required for No or N/A	Recommended for No
D14	Were withdrawal and lost-to-follow-up requirements reviewed?	Yes No N/A	At least three telephone attempts and documentation of all efforts.	Required for No or N/A	Recommended for No

E. Device Training and Accountability

ID	CTMS Question	Checklist Response	CRA Guidance / Comment Prompt	Comment Rule	Action Item Trigger
E01	Was the PHIL™ Instructions for Use reviewed?	Yes No N/A	Record IFU version, trainer, trained operators, and training date.	Required for No or N/A	Recommended for No
E02	Were qualified PHIL™ operators identified?	Yes No N/A	Identify any operators requiring additional training.	Required for No or N/A	Recommended for No
E03	Were PHIL™ formulations and kit components reviewed?	Yes No N/A	LV, 25%, 30%, and 35%; PHIL™ syringe, DMSO syringe, and adaptor.	Required for No or N/A	Recommended for No
E04	Were device preparation, administration, warnings, and precautions reviewed?	Yes No N/A	Note whether hands-on training was provided.	Required for No or N/A	Recommended for No
E05	Were device-storage requirements reviewed?	Yes No N/A	Record storage location, access controls, and whether the area was observed.	Required for No or N/A	Recommended for No
E06	Were device receipt and accountability procedures reviewed?	Yes No N/A	Include lot/reference number, expiration, dispensing, use, return, and reconciliation.	Required for No or N/A	Recommended for No
E07	Were comparator-device requirements reviewed?	Yes No N/A	Confirm Onyx LES availability and trained operators.	Required for No or N/A	Recommended for No
E08	Were device-deficiency and product-return procedures reviewed?	Yes No N/A	Confirm malfunctioning product will be quarantined, documented, and returned.	Required for No or N/A	Recommended for No
E09	Was responsibility for device accountability assigned?	Yes No N/A	Record primary and backup personnel.	Required for No or N/A	Recommended for No

F. Safety Reporting

ID	CTMS Question	Checklist Response	CRA Guidance / Comment Prompt	Comment Rule	Action Item Trigger
F01	Was the adverse-event collection period reviewed?	Yes No N/A	AE collection begins at randomization and continues through 180 days.	Required for No or N/A	Recommended for No
F02	Was AE collection for surgery before randomization reviewed?	Yes No N/A	AEs occurring during and after surgery must be collected.	Required for No or N/A	Recommended for No
F03	Were AE, ADE, SAE, SADE, UADE, and device-deficiency definitions reviewed?	Yes No N/A	Record definitions requiring clarification.	Required for No or N/A	Recommended for No
F04	Was investigator responsibility for seriousness and relatedness reviewed?	Yes No N/A	Assess separately for device, MMAE, surgery, retreatment, study disease, and underlying conditions.	Required for No or N/A	Recommended for No
F05	Were death-reporting requirements reviewed?	Yes No N/A	Notify Sponsor within 3 working days of awareness.	Required for No or N/A	Recommended for No
F06	Were other SAE-reporting requirements reviewed?	Yes No N/A	Notify Sponsor within 5 working days of awareness.	Required for No or N/A	Recommended for No
F07	Were UADE-reporting requirements reviewed?	Yes No N/A	Notify Sponsor and reviewing IRB as soon as possible and no later than 10 working days.	Required for No or N/A	Recommended for No
F08	Were EDC and backup safety-reporting methods reviewed?	Yes No N/A	EDC is primary. Use the designated safety email when EDC is unavailable.	Required for No or N/A	Recommended for No
F09	Were NIHSS requirements for focal neurological changes reviewed?	Yes No N/A	NIHSS is required at event onset and at least 24 hours later.	Required for No or N/A	Recommended for No
F10	Were supporting source-document requirements reviewed?	Yes No N/A	De-identified records may be required for CEC, DSMB, or Sponsor review.	Required for No or N/A	Recommended for No
F11	Did site personnel demonstrate adequate understanding of safety reporting?	Yes No N/A	Briefly document discussion of a death, SAE, UADE, or neurological-event scenario.	Required for No or N/A	Recommended for No

G. Data, Imaging, and Monitoring

ID	CTMS Question	Checklist Response	CRA Guidance / Comment Prompt	Comment Rule	Action Item Trigger
G01	Were the EDC system and eCRF process reviewed?	Yes No N/A	Record trained users and pending access.	Required for No or N/A	Recommended for No
G02	Were source-document expectations reviewed?	Yes No N/A	EMR is the primary source. Worksheets may be used for data not routinely recorded in the EMR.	Required for No or N/A	Recommended for No
G03	Were good documentation practices reviewed?	Yes No N/A	Note any site-specific source-document concerns.	Required for No or N/A	Recommended for No
G04	Was PI responsibility for eCRF completeness and approval reviewed?	Yes No N/A	Confirm the site’s review process.	Required for No or N/A	Recommended for No
G05	Were imaging acquisition and submission requirements reviewed?	Yes No N/A	Record the applicable imaging manual, submission system, and trained personnel.	Required for No or N/A	Recommended for No
G06	Were core laboratory and CEC/DSMB document requests reviewed?	Yes No N/A	Confirm the site can provide de-identified supporting records promptly.	Required for No or N/A	Recommended for No
G07	Were subject confidentiality and de-identification reviewed?	Yes No N/A	Document the secure transfer method.	Required for No or N/A	Recommended for No
G08	Was monitor access to source records confirmed?	Yes No N/A	Describe on-site and remote access arrangements.	Required for No or N/A	Recommended for No
G09	Were monitoring expectations reviewed?	Yes No N/A	Include visit scheduling, PI availability, query response, and action-item follow-up.	Required for No or N/A	Recommended for No
G10	Were protocol-deviation documentation and reporting requirements reviewed?	Yes No N/A	Confirm deviations will be documented and reported according to Sponsor and IRB/EC requirements.	Required for No or N/A	Recommended for No

H. Investigator Oversight and Site Operations

ID	CTMS Question	Checklist Response	CRA Guidance / Comment Prompt	Comment Rule	Action Item Trigger
H01	Were the PI’s responsibilities and oversight obligations reviewed?	Yes No N/A	Include subject safety, protocol compliance, staff supervision, data accuracy, and safety reporting.	Required for No or N/A	Recommended for No
H02	Did the PI describe how ongoing study oversight will be maintained?	Yes No N/A	Summarize meetings, subject review, safety review, and escalation processes.	Required for No or N/A	Recommended for No
H03	Are adequate qualified study staff and backup personnel available?	Yes No N/A	Consider screening, procedures, follow-up, data entry, imaging, and safety reporting.	Required for No or N/A	Recommended for No
H04	Was neurosurgery and neurointerventional coordination reviewed?	Yes No N/A	Describe how both procedures will be scheduled within protocol timelines.	Required for No or N/A	Recommended for No
H05	Are required facilities and clinical services available?	Yes No N/A	Include operating room, angiography, CT/MRI, inpatient care, and emergency support.	Required for No or N/A	Recommended for No
H06	Were recruitment expectations discussed?	Yes No N/A	Record estimated eligible and randomized subjects per month.	Required for No or N/A	Recommended for No
H07	Were potential competing studies discussed?	Yes No N/A	Note possible effect on enrollment or eligibility.	Required for No or N/A	Recommended for No
H08	Did the PI or site personnel express any unresolved concerns regarding study conduct?	Yes No N/A	If Yes, summarize the concerns and required Sponsor follow-up.	Required for Yes or N/A	Recommended for Yes

4. Action Items

Action Item ID	Related Checklist Item	Action Item Description	Responsible Party	Opened Date	Due Date	Status	Completion Date	Resolution Comments
System-generated						Open In Progress Closed Cancelled

5. CRA Conclusion

Field	Checklist Choice	Template Text
SIV Completion Status	All required SIV topics completed SIV topics completed with open follow-up items Additional SIV training or follow-up required	Select the option that best matches the current site status.
CRA Conclusion		Free text field.

6. Report Workflow & Validation Rules

Workflow Metadata & Electronic Signatures

Prepared By: Auto-populate from report creator
Prepared Date: System-generated
Reviewed By: Workflow-assigned reviewer
Review Date: System-generated
Approved By: Workflow-assigned approver
Approval Date: System-generated
Electronic Signature Status: Signed Pending
Report Version: System-generated