PROVE (Retrospective Cefiderocol Chart Review Study) STU0001
ACTIVE
Study Information
| Protocol Title |
|---|
| A retrospective chart review study of cefiderocol real world outcomes and safety in the treatment of patients with Gram-negative bacterial infections (GNBI) in the US and Europe |
| Short Title |
| PROVE (Retrospective Cefiderocol Chart Review Study) |
| Study Phase/Type of Study |
| Phase1 |
| Shionogi Product Code |
| 000001 |
| Status |
| Active |
Country / Site list
| Country Name | Site Number | Site Name | PI Name | Current Status |
|---|---|---|---|---|
| UK | 001 | Name | Name | Active |
| Spain | 002 | Name | Name | Active |
| Germany | 003 | Name | Name | Active |
| Germany | 004 | Name | Name | Active |
Study Personnel
| Full name | Affiliation | Function | Start date | End date | Email address | Phone number | Site/country responsibility |
|---|---|---|---|---|---|---|---|
| Firstname Lastname | Shionogi | Market Access | DD/MM/YYYY | DD/MM/YYYY | firstname.lastname@emailaddress.com | +44 1234 567890 | All |
| Firstname Lastname | CRO/vendor | Regulatory | DD/MM/YYYY | DD/MM/YYYY | firstname.lastname@emailaddress.com | +44 1234 567890 | Germany |
- 1 - Study Management
- 2 - Study Documents
- 3 - Regulatory
- 3 - Regulatory Country-Specific Submissions
- 4 - IRB or IEC and other Approvals
- 5 - Site Management
- 6 - IP and Trial Supplies
- 7 - Pharmacovigilance
- 8 - Central and Local Testing
- 9 - Third parties
- 10 - Data Management
- 11 - Statistics
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General (3)
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Meetings (0)
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Study Committee (0)
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01.03.01 - Committee Process (0)
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01.03.02 - Committee Member List (0)
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01.03.03 - Committee Output (0)
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01.03.04 - Committee Member Curriculum Vitae (0)
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01.03.05 - Committee Member Financial Disclosure Form (0)
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01.03.06 - Committee Member Contract (0)
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01.03.07 - Committee Member Confidentiality Disclosure Agreement (0)
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01.03.01 - Committee Process (0)
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Study Oversight (0)
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01.01.01 - Study Master File Plan (0)
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01.01.02 - Study Management Plan (0)
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01.01.03 - Quality Plan (0)
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01.01.04 - List of SOPs Current During Study (0)
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01.01.05 - Operational Procedure Manual (0)
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01.01.06 - Enrolment Plan (0)
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01.01.07 - Communication Plan (0)
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01.01.08 - Monitoring Plan (0)
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01.01.09 - Medical Monitoring Plan (0)
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01.01.10 - Publication Policy (0)
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01.01.11 - Debarment Statement (0)
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01.01.12 - Study Status Report (0)
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01.01.13 - Physician Newsletters (0)
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01.01.14 - Audit Certificate (0)
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01.01.15 - Filenote Master List (0)
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01.01.16 - Study Risk Management Plan (0)
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01.01.17 - Vendor Management Plan (0)
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01.01.18 - Roles and Responsibility Matrix (0)
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01.01.19 - Transfer of Regulatory Obligations (0)
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01.01.20 - Operational Oversight (0)
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01.01.01 - Study Master File Plan (0)
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Study Team (0)
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General (1)
- Patient Documentation (0)
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Reports (0)
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Study Documentation (0)
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02.01.01 - Investigator's Brochure (0)
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02.01.02 - Protocol (0)
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02.01.03 - Protocol Synopsis (0)
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02.01.04 - Protocol Amendment (0)
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02.01.05 - Financial Disclosure Summary (0)
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02.01.06 - Insurance (0)
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02.01.07 - Sample Case Report Form (0)
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02.01.10 - Report of Prior Investigations (0)
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02.01.11 - Marketed Product Material (0)
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02.01.01 - Investigator's Brochure (0)
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General (0)
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Site Initiation (0)
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Site Management (0)
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05.04.01 - Patient Log
Enrolment Log (0)
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05.04.02 - Source Data Verification (0)
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05.04.03 - Monitoring Visit Report (0)
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05.04.04 - Visit Log (0)
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05.04.05 - Additional Monitoring Activity (0)
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05.04.06 - Protocol Deviations (0)
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05.04.07 - Financial Documentation (0)
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05.04.08 - Final Study Close Out Monitoring Report (0)
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05.04.09 - Notification to Investigators of Safety Information (0)
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05.04.10 - Patient Identification Log (0)
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05.04.11 - Source Data (0)
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05.04.12 - Monitoring Visit Follow-up Documentation (0)
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05.04.13 - Patient Eligibility Verification Forms and Worksheets (0)
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05.04.01 - Patient Log
Enrolment Log (0)
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Site Selection (0)
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Site Set-up (0)
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05.02.01 - Acceptance of Investigator Brochure (0)
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05.02.02 - Protocol Signature Page (0)
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05.02.03 - Protocol Amendment Signature Page (0)
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05.02.04 - Physician Curriculum Vitae (0)
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05.02.05 - Sub-Investigator Curriculum Vitae (0)
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05.02.06 - Other Curriculum Vitae (0)
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05.02.07 - Site Staff Qualification Supporting Information (0)
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05.02.08 - Form FDA 1572 (0)
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05.02.09 - Investigator Regulatory Agreement (0)
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05.02.10 - Financial Disclosure Form (0)
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05.02.11 - Data Privacy Agreement (0)
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05.02.12 - Study Agreement (0)
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05.02.13 - Indemnity (0)
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05.02.14 - Other Financial Agreement (0)
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05.02.17 - IP Site Release Documentation (0)
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05.02.18 - Site Signature Sheet (0)
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05.02.19 - Investigators Agreement (Device) (0)
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05.02.20 - Coordinating Investigator Documentation (0)
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05.02.01 - Acceptance of Investigator Brochure (0)
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General (0)
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Interactive Response Technology (0)
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IP Allocation Documentation (0)
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IP Documentation (0)
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06.01.01 - IP Supply Plan (0)
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06.01.02 - IP Instructions for Handling (0)
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06.01.03 - IP Sample Label (0)
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06.01.04 - IP Shipment Documentation (0)
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06.01.05 - IP Accountability Documentation (0)
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06.01.06 - IP Transfer Documentation (0)
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06.01.07 - IP Re-labelling Documentation (0)
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06.01.08 - IP Recall Documentation (0)
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06.01.09 - IP Quality Complaint Form (0)
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06.01.10 - IP Return Documentation (0)
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06.01.11 - IP Certificate of Destruction (0)
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06.01.12 - IP Retest and Expiry Documentation (0)
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06.01.01 - IP Supply Plan (0)
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IP Release Process Documentation (0)
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Non-IP Documentation (0)
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Storage (0)
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Facility Documentation (0)
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08.01.01 - Certification or Accreditation (0)
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08.01.02 - Laboratory Validation Documentation (0)
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08.01.03 - Laboratory Results Documentation (0)
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08.01.04 - Normal Ranges (0)
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08.01.05 - Central Laboratory Manual (0)
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08.01.06 - Supply Import Documentation (0)
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08.01.07 - Head of Facility Curriculum Vitae (0)
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08.01.08 - Standardization Methods (0)
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08.01.01 - Certification or Accreditation (0)
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General (0)
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Sample Documentation (0)
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Data Capture (0)
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Data Management Oversight (0)
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Database (0)
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10.03.01 - Database Specifications (0)
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10.03.02 - Edit Check Plan (0)
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10.03.03 - Edit Check Programming (0)
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10.03.04 - Edit Check Testing (0)
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10.03.05 - Approval for Database Activation (0)
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10.03.06 - External Data Transfer Specifications (0)
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10.03.07 - Data Entry Guidelines (Paper) (0)
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10.03.08 - SAE Data Reconciliation (0)
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10.03.09 - Dictionary Coding (0)
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10.03.10 - Data Review Documentation (0)
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10.03.11 - Database Lock and Unlock Approval (0)
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10.03.12 - Database Change Control (0)
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10.03.01 - Database Specifications (0)
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EDC Management (0)
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General (0)
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Analysis (0)
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11.03.01 - Data Definitions for Analysis Datasets (0)
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11.03.02 - Analysis QC Documentation (0)
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11.03.03 - Interim Analysis Raw Datasets (0)
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11.03.04 - Interim Analysis Programs (0)
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11.03.05 - Interim Analysis Datasets (0)
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11.03.06 - Interim Analysis Output (0)
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11.03.07 - Final Analysis Raw Datasets (0)
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11.03.08 - Final Analysis Programs (0)
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11.03.09 - Final Analysis Datasets (0)
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11.03.10 - Final Analysis Output (0)
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11.03.11 - Patient Evaluability Criteria and Patient Classification (0)
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11.03.01 - Data Definitions for Analysis Datasets (0)
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General (0)
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Randomization (0)
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Report (0)
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Statistics Oversight (0)