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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