Monitoring Visit Report - Thomas Jefferson University



Monitoring Visit Report

|Protocol Name/Number:      |

| |

|Visit Date::      |Person (s) contacted during visit/Position: |

|Investigator:      |      |

|Site Name and Address:      |      |

|      |      |

|      |      |

|      |Monitor (s):      |

| | |

|Type of Visit: Routine/Scheduled |

|Unscheduled/For Cause: ______________________________________________________ |

|Study Close-out (Please √ Reason) Completion Suspension Termination |

|Subject Status:      Date of First Subject Enrolled      Date of Most Recent Subject Enrolled |

|      # Screened |      # Enrolled |      # Active |      # Completed |

|       # SAEs       # CRFs Reviewed:       # CRFs Collected |

|Activity |Yes |No |N/A |

|A. Verification of Regulatory Documents |

|Protocol | | | |

|Signed Protocol Signature Page | | | |

|Protocol Amendment(s) | | | |

|Signed Protocol Signature Page for Amendment(s) | | | |

|Investigator Drug Brochure | | | |

|FDA approved package label/insert | | | |

|Form FDA 1571 | | | |

|Form FDA 1572 | | | |

|Revised Form FDA 1571 (s) | | | |

|Revised Form FDA 1572 (s) | | | |

|CVs of All Investigator(s) | | | |

|Medical Licenses for All Investigator(s) | | | |

|Original IRB Approval Letters for Protocol and Consent | | | |

|IRB Annual Report | | | |

|IRB Annual Re-approval Letter (s) | | | |

|IRB Approved Informed Consent | | | |

|IRB Approved Revised Informed Consent (s) | | | |

|IRB Approved Patient Advertisement/ Recruitment Tools | | | |

|Safety Updates/Reports submitted to IRB | | | |

|IRB Multiple Assurance (No.____________) | | | |

|IRB Correspondence File | | | |

|General Correspondence File | | | |

|Monitor Site Visit Log | | | |

|Staff Signature Log/Delegation of Responsibility Log | | | |

|Subject Screening/Enrollment Log | | | |

|Laboratory Licensure/Accreditation | | | |

|Laboratory Normal Values | | | |

|CV for Laboratory Director | | | |

|B. Financial Documents |

|Confidentiality Agreement | | | |

|Clinical Investigation Agreement and Budget | | | |

|Letter of Indemnification | | | |

|C. Workload/Facility Status |

|Has Investigator accepted new studies since last visit? | | | |

|Is Investigator properly supervising other personnel? | | | |

|Is Investigator devoting enough time for the study? | | | |

|Any changes in site key personnel since last visit? | | | |

|Has facility/work area changed since last visit? | | | |

|Are treatment facilities adequate? | | | |

|D. Subject Verification and CRF Review |

|Is subject enrollment adequate? | | | |

|Is subject enrollment log up to date? | | | |

|Do subjects meet eligibility requirements? | | | |

|Have subjects signed informed consent form? | | | |

|Are CRFs completed properly and on a timely basis? | | | |

|Are CRFs legible, accurate and complete? | | | |

|Are source documents legible, accurate and complete? | | | |

|Were source documents checked for CRF reviewed? | | | |

|Were the data collected verifiable? | | | |

|Were there any inconsistencies noted in reviews? | | | |

|Were study procedures done in accordance with the protocol? | | | |

|Is follow-up current and properly recorded? | | | |

|Are dropouts/withdrawn subjects documented? | | | |

|Have adverse events been adequately documented? | | | |

|Have there been any protocol violations since last visit? | | | |

|Do site records match up with Sponsor records? | | | |

|E. Investigator/Monitor Meeting |

|Reviewed all significant findings? | | | |

|Discussed all action items? | | | |

|Reviewed regulatory issues specific to visit? | | | |

|Reviewed corrected items from previous visit? | | | |

|F. Investigational Product Accountability |

|Are product storage facilities adequate, secure? | | | |

|Has location of product storage changed since last visit? | | | |

|Product forms complete and up to date? | | | |

|Product inventory checked and counted? | | | |

|Accountability Form complete and up to date? | | | |

|G. Overall Review of Study Status |

|Is maintenance of records complete? | | | |

|Is site in compliance with protocol and IRB? | | | |

|Are participants accruing within timelines? | | | |

|Is additional clinical/technical training required? | | | |

|H. For Close-out Visits Only: |

|Collected all CRFs and other data worksheets? | | | |

|Reconciled product accountability records? | | | |

|Investigator advised on unused product return? | | | |

|Investigator advised to notify IRB of completion? | | | |

|Investigator advised of records retention policy? | | | |

|Investigator advised of records retention policy? | | | |

|Comments: |

|Finding |Action Item |Resolution |

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____________________________ ________________________________

Monitor’s Name (please print) Signature Date

____________________________ ________________________________

Investigator’s Name (please print) Signature Date

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