Get Site Monitoring Visit Follow Up Letter

The Site Monitoring Visit Follow Up Letter is an essential document that summarizes the findings from a monitoring visit. Filling it out accurately online ensures proper communication and documentation of observations made during the visit.

Follow the steps to successfully complete the form online:

1. Press the ‘Get Form’ button to access the Site Monitoring Visit Follow Up Letter and open it in your editing tool.
2. Insert the name of the Principal Investigator (PI) in the header, followed by the site name, address, city, state, zip code, and country.
3. Enter the site number, protocol name, protocol number, and date of the monitoring visit in the designated fields.
4. Begin the letter with a salutation addressing the PI by name.
5. In the body of the letter, summarize the observations made during the monitoring visit. Ensure to include names of personnel present during the visit.
6. Systematically address each observation area as indicated in the form, starting with action items from the previous visit and detailing compliance with recruitment methods, informed consent, and protocol adherence.
7. List any adverse events or unanticipated device effects, ensuring thorough documentation.
8. Review record keeping practices, noting any regulatory files, essential documents, or data clarification forms that were reviewed during the visit.
9. Discuss staff training needs and whether facilities remain sufficient for study activities.
10. Document any regulatory audits conducted since the last monitoring visit.
11. Conclude with a detailed description of discussions held with staff regarding deficiencies and list action items that need to be completed, along with deadlines.
12. Specify the date and time for the next monitoring visit and provide your contact information for follow-up.

Complete your Site Monitoring Visit Follow Up Letter online today to ensure accurate documentation and effective communication.