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Monitoring Visit Log - National Institute of Dental and … - nemis registration log in
Tool Summary Sheet
|Tool: |Monitoring Visit Log |
|Purpose: |To record all monitoring visits, beginning with Site Initiation. |
|Audience/User: |Study Coordinators, Principal Investigators (PIs), other site staff, clinical monitor |
|Details: |This log should provide a comprehensive list of all monitoring visits. It is required for both observational |
| |and interventional clinical research studies. |
|Best Practice Recommendations:|Record monitoring visits as they occur, to ensure completeness and accuracy of the data. If a visit occurs over|
| |more than one day, each day should be recorded on a separate line. |
| |The clinical site monitor should sign each line as a monitoring visit begins. |
| |Number each page and maintain this log in the Essential Documents Binder, behind the ‘Clinical Site Monitoring |
| |Visits’ tab. (Synonyms for this binder include Investigator Binder, Regulatory Binder, Investigator Site File |
| |(ISF), and Study File.) |
| |Store pages in reverse chronological order, with the newest pages of the log placed at the front of the |
| |section. |
| |At the conclusion of the study, identify the final page of the log by checking the box in the footer. |
| |Remove this Tool Summary Sheet before use of the log. |
Tool Revision History:
|Version Number |Version Date |Summary of Revisions Made: |
|1.0 |05Feb2010 |First approved version |
|2.0 |02Mar2010 |Removed automatic page numbering |
|3.0 |04Jan2012 |Added Tool Summary Sheet; no revisions to the log |
|4.0 |14Mar2012 |Revised Tool Summary Sheet and added check box to footer |
Monitoring Visit Log
|Investigator Name: |Protocol: |Site Number: |
|Name |Signature |Purpose of Visit |Date of Visit |
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