Get Thomas Jefferson University Monitoring Visit Report 2017-2025

This guide provides clear and comprehensive instructions on completing the Thomas Jefferson University Monitoring Visit Report online. By following these steps, you will ensure that your submission is accurate and complete.

Follow the steps to fill out the form effectively.

1. Press the ‘Get Form’ button to access the Monitoring Visit Report and open it in your preferred online editor.
2. Begin by filling out the 'Protocol Name/Number' and 'Visit Date' fields accurately. Ensure that the protocol information corresponds with the study you are monitoring.
3. In the 'Person(s) contacted during visit/Position' section, list the individuals you interacted with, along with their respective roles at the site.
4. Provide the 'Investigator' name, followed by the 'Site Name and Address' where the monitoring visit occurred.
5. Document the names of the 'Monitor(s)' who conducted the visit in the appropriate section.
6. Indicate the type of visit by checking either 'Routine/Scheduled' or 'Unscheduled/For Cause' as applicable to the situation.
7. For the 'Study Close-out' section, check the box next to the appropriate reason: 'Completion', 'Suspension', or 'Termination'.
8. Follow each sub-step in section A for the verification of regulatory documents; check off and note compliance for each listed document, such as the signed protocol and investigator drug brochures.
9. In the 'Financial Documents' subsection, confirm that all necessary documents, including the Clinical Investigation Agreement and Budget, are included.
10. Assess the 'Workload/Facility Status' and provide feedback regarding the investigator's supervision, study time allocation, and any updates in site personnel.
11. Fill out the 'Subject Verification and CRF Review' section carefully, noting aspects such as subject enrollment, informed consent forms, and the accuracy of CRFs.
12. Complete the 'Investigator/Monitor Meeting' section by verifying that key findings, action items, and regulatory issues were addressed during the visit.
13. Check the 'Investigational Product Accountability' section to ensure that all product storage, inventory, and accountability forms are correct.
14. In the 'Overall Review of Study Status', evaluate overall compliance with the protocol, ensuring participants are meeting timelines and that proper training is provided.
15. For close-out visits only, ensure that all relevant documentation, including CRFs and product accountability records, have been reconciled.
16. Finally, add any comments, findings, action items, and resolutions in the designated space. Sign and date the report, ensuring both monitor and investigator signatures are present.

Take the next step in your documentation process by completing the Monitoring Visit Report online today.