✓ SDV per §5.18.3 — 94% coverage
✓ ICF versions current per §4.8.2
✓ IP reconciled — 0 discrepancies
✓ §8 essential documents — complete
⚠ 2 open protocol deviations (§5.18.3 documented)
1 SAE — §5.17 reporting active
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1
Site Information
Site Name
Mercy General Hospital
Site Number
#047
Principal Investigator
Dr. Marcus Okafor, MD PhD
Sub-Investigator(s)
Dr. Anna Reyes, Dr. David Park
Study Coordinator
Jennifer Walsh, RN
Address
1450 Elmwood Blvd, Boston, MA 02118
IRB / IEC
WIRB-Copernicus (Protocol #NVG-301-BOS)
FDA IND Number
IND 148-922
Protocol Version
v4.1 (2025-11-03)
EDC System
Medidata Rave v19.3
Previous Visit
January 14, 2026 (Routine)
Days Since Last Visit
55 days
2
Subject Enrollment & Disposition
18
Screened
14
Enrolled (Active)
3
Screen Failures
2
Discontinued
11
Completed Treatment
1
In Follow-up
| Subject ID | Screening Date | Randomization Date | Treatment Arm | Current Cycle | Status |
|---|---|---|---|---|---|
| 047-001 | 2024-09-12 | 2024-09-18 | Arm A (NVG-2847 + SOC) | Cycle 8 | Active |
| 047-002 | 2024-09-20 | 2024-09-27 | Arm B (Placebo + SOC) | Cycle 8 | Active |
| 047-003 | 2024-10-05 | 2024-10-14 | Arm A (NVG-2847 + SOC) | Cycle 7 | Active |
| 047-004 | 2024-10-18 | — | — | — | Screen Failure |
| 047-005 | 2024-11-02 | 2024-11-10 | Arm A (NVG-2847 + SOC) | Cycle 6 | Active |
| 047-006 | 2024-11-15 | 2024-11-22 | Arm B (Placebo + SOC) | — | Discontinued |
| 047-007 | 2024-12-03 | 2024-12-09 | Arm A (NVG-2847 + SOC) | Cycle 5 | Active |
| 047-008 | 2025-01-10 | 2025-01-17 | Arm B (Placebo + SOC) | Cycle 4 | Active |
Showing 8 of 14 active subjects. Full subject listing available in Appendix A.
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3
Protocol Deviations
PD-047-012 · Open
Visit window deviation — Subject 047-003, Cycle 7 Day 1
Cycle 7 Day 1 assessment for Subject 047-003 occurred on Day 23 (±6 days from protocol-specified Day 17±3 window). PK sampling and efficacy assessments completed outside acceptable window. Root cause: subject hospitalization for unrelated event (community-acquired pneumonia). Hospitalization occurred prior to this CRA visit and was previously reported in the safety narrative for AE-047-031.
PD-047-014 · Open
Concomitant medication not captured at Screening — Subject 047-008
Metformin 500 mg BID (ongoing, pre-existing diabetes management) was not captured in the concomitant medications CRF at Screening. Medication was identified during Cycle 2 Day 1 visit and added to the CRF on 2026-01-24. Eligibility criteria review confirmed no impact on subject eligibility (diabetes is not an exclusion criterion). No safety implications identified.
PD-047-011 · Closed
ECG not performed within 30-min pre-dose window — Subject 047-001, Cycle 5
ECG was performed 48 minutes before dosing (protocol requires within 30 min). CAP accepted by sponsor on 2026-02-05. Site retrained on pre-dose assessment sequencing. No further deviations of this type since CAP implementation.
Automate deviation tracking → Artha automatically flags visit window deviations, CAP status, and protocol non-compliance — no manual CRF review required.
4
Source Data Verification (SDV)
Demographics
100%
14/14 subjects verified
Efficacy (Primary)
100%
All ORR data verified
Adverse Events
100%
31 AEs verified vs. source
Lab Values
91%
3 panels pending lab report upload
Vital Signs
100%
All visits verified
Concomitant Meds
88%
Subjects 047-007, 047-008 pending
SDV Narrative: SDV was conducted for 47 source documents across 14 active subjects. Overall coverage rate of 94% exceeds the sponsor-specified minimum of 90% for routine monitoring visits. Three outstanding lab panels for Subjects 047-007, 047-008, and 047-012 are awaiting upload from Quest Diagnostics (expected within 5 business days). Discrepancies identified and corrected: 4 minor transcription errors in lab result CRF entries (values transposed; corrected via audit-trailed queries in Medidata Rave during this visit). No clinically significant data integrity issues identified.
5
Informed Consent Review
| Subject | ICF Version in File | Current IRB-Approved Version | Date Signed | Re-consent Required | Status |
|---|---|---|---|---|---|
| 047-001 | v3.0 (2024-07-15) | v3.0 | 2024-09-18 | No | ✓ Current |
| 047-002 | v3.0 (2024-07-15) | v3.0 | 2024-09-27 | No | ✓ Current |
| 047-003 | v3.0 (2024-07-15) | v3.0 | 2024-10-14 | No | ✓ Current |
| 047-005 | v3.0 (2024-07-15) | v3.0 | 2024-11-10 | No | ✓ Current |
| 047-007 | v3.0 (2024-07-15) | v3.0 | 2024-12-09 | No | ✓ Current |
| 047-008 | v3.0 (2024-07-15) | v3.0 | 2025-01-17 | No | ✓ Current |
All 14 active subjects reviewed. ICF v3.0 is current IRB-approved version as of 2025-11-20. No amendment pending.
ICF Findings: All subjects have current ICF versions on file with original signatures and dates. Witness signatures present where required per site SOPs. No re-consent obligations identified at this visit. Prior amendment (v2.1 → v3.0) re-consent was completed and verified at the January 14, 2026 monitoring visit. The ICF version log in the regulatory binder is current and matches the versions held in each subject's source file.
6
Investigational Product (IP) Accountability
IP Name
NVG-2847 (navitrelisib)
Formulation
100 mg film-coated tablets, oral
Storage Condition
2–8°C (refrigerated)
Temperature Excursion
None recorded
Pharmacy Contact
Robert Tran, PharmD
Last Reconciliation
January 14, 2026
| Lot Number | Received (units) | Dispensed | Returned / Destroyed | On-Hand Balance | Reconciliation |
|---|---|---|---|---|---|
| NVG-LOT-2401 | 420 | 312 | 28 (destroyed on-site, 2025-12-10) | 80 | ✓ Balanced |
| NVG-LOT-2501 | 280 | 148 | 0 | 132 | ✓ Balanced |
| Placebo-LOT-P24 | 360 | 196 | 14 (destroyed on-site, 2025-12-10) | 150 | ✓ Balanced |
IP Accountability Summary: Physical counts conducted by CRA with pharmacy staff present. All lot counts reconcile exactly with dispensing records in the Interactive Response Technology (IRT) system. Temperature monitoring log (Datalogger ID: TL-047-03) reviewed — no excursions recorded since last visit. Drug storage area access is restricted and appropriately secured per site SOPs. Destruction records complete and witnessed. Current supply adequate for approximately 8 weeks at current dosing rate; resupply order NVG-RSP-047-08 was confirmed with the sponsor supply team during this visit.
7
Regulatory Binder Review
Verified against ICH E6(R3) §8 Essential Documents checklist (§8.2 Before Commencement + §8.3 During Conduct). All 10 categories present and current.
| Document | Required | On File | Version / Date | Status |
|---|---|---|---|---|
| Protocol + Amendments | Yes | Yes | v4.1, 2025-11-03 | ✓ Current |
| IRB/IEC Approval | Yes | Yes | Renewal approved 2025-08-15 | ✓ Current |
| Investigator Brochure | Yes | Yes | Ed. 9 (2025-09-01) | ✓ Current |
| FDA Form 1572 | Yes | Yes | Updated 2025-10-12 | ✓ Signed |
| CVs — All Investigators | Yes | Yes | All within 2 years | ✓ Current |
| GCP Training Certificates | Yes | Yes | All staff current | ✓ Current |
| Lab Normal Ranges + Certifications | Yes | Yes | 2025 Q4 update | ✓ Current |
| Clinical Trial Agreement (CTA) | Yes | Yes | Executed 2024-07-01 | ✓ Executed |
| Delegation of Authority Log | Yes | Yes | Updated 2026-01-10 | ✓ Current |
| Site Monitoring Visit Log | Yes | Yes | Updated this visit | ✓ Current |
8
Safety Reporting — SAE / SUSAR
SAE-047-003 · Under Sponsor Review
Grade 3 Neutropenia — Subject 047-003, Cycle 7
Subject 047-003 experienced Grade 3 neutropenia (ANC <1.0 × 10⁹/L) on Day 14 of Cycle 7. Subject was hospitalized for 3 days for IV antibiotics and G-CSF support (2026-02-18 to 2026-02-21). Event resolved to Grade 1 by 2026-02-24. PI assessed as possibly related to study drug (NVG-2847). Dose reduction per protocol (Section 9.3.1) was implemented: Cycle 8 dose reduced from 200 mg to 150 mg QD. Initial SAE report submitted to sponsor within 24 hours; follow-up report submitted on 2026-02-25.
Safety Summary: 31 total adverse events recorded across 14 subjects since study initiation. 1 SAE open (Grade 3 neutropenia, details above). All AEs reported within required timelines; documentation complete and source-verified. No deaths. No new safety signals identified at this site. The PI confirms awareness of current IB safety data and the evolving neutropenia profile described in Amendment 4 to the Investigator Brochure. Site staff have been reminded of expedited reporting requirements per ICH E6(R3) §5.17.1 (24-hour initial SAE notification to sponsor) and §5.17.2 (7-day written follow-up report for fatal or life-threatening SUSARs). Reporting timelines for SAE-047-003 are compliant to date.
9
Action Items
1
Submit CAP for PD-047-012 (Cycle 7 visit window deviation)
Draft and submit corrective action plan addressing root cause of visit window deviation for Subject 047-003. Include retraining plan for study coordinator on visit window tracking procedures.
2
Upload outstanding lab results for Subjects 047-007, 047-008, 047-012
3 Quest Diagnostics lab panels not yet uploaded to Medidata Rave. Coordinate with lab to confirm receipt and upload within 5 business days. Notify CRA when complete.
3
Complete concomitant medication SDV for Subjects 047-007 and 047-008
Source documents for concomitant medication pages were not available during this visit (medication administration record under audit by pharmacy). Site to provide access remotely or during next visit.
4
Confirm SUSAR determination and file regulatory reports (SAE-047-003)
Sponsor Medical Review to determine SUSAR status for Grade 3 neutropenia event. If SUSAR confirmed: expedited IND safety report required to FDA within 7 calendar days of determination (ICH E6(R3) §5.17.2 / 21 CFR §312.32(c)(2)). Sponsor must notify all participating investigators within the same window. Site to update regulatory binder and PI delegation log upon receipt of sponsor notification.
5
Schedule next routine monitoring visit
Next monitoring visit target: 8–10 weeks from this visit (May 5–19, 2026). Site coordinator to confirm dates with Dr. Chen. Priority enrollment of 6 additional subjects should be reviewed at next visit.
Artha generates action items like these automatically. Every finding becomes a tracked action item with owner, due date, and priority — no manual write-up required.
✓
Signatures & Attestation
This monitoring visit report was prepared by Artha AI in accordance with ICH E6(R3) §5.18.3 (on-site monitoring documentation requirements) and reviewed by the named CRA. The information accurately reflects findings observed during the visit conducted on March 10, 2026. Source data verification was conducted per §5.18.3(b); essential document completeness verified against the §8 checklist; adverse event timelines assessed against §5.17 reporting requirements. All findings are documented in the site Trial Master File per 21 CFR §312.68.
Dr. Sarah Chen
Clinical Research Associate, Novagen Therapeutics
Signed: March 10, 2026 · 16:42 UTC
Jennifer Walsh, RN
Study Coordinator, Mercy General Hospital
Acknowledged: March 11, 2026
Dr. Marcus Okafor, MD PhD
Principal Investigator, Site #047
Signed: March 12, 2026
Report ID: NVG-2847-301-047-MVR-2026-03-10 · Generated by Artha AI · arthaos.polsia.app