Click on a tool/document name in the table below to open the individual template. Save the tool to your computer desktop and reopen it before completing. The below documents are protected; however, to unprotect use the password "qip."
Check our website regularly for new and updated tools. Submit your request for a new tool here.
Tools |
Instructions |
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Use this log to document participant enrollment, basic demographics, and early terminations/withdrawals.
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Use this log to keep track of the Human Subjects Training status for each member of the study staff on HSPH protocols. For more information on HSPH Human Subjects Training requirements please visit our Human Subjects Training page.
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| IRB Submission Log |
Use this log to document HSPH IRB submissions, notifications, required responses, and deadlines. Refer to our IRB Meetings/Deadlines page to determine IRB submission deadlines.
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| Note To File Template |
Use this Note to File Template to document any discrepancey, deviation, or missing material(s) in the study file so as to provide a complete history of the protocol. Retain this note chronologically in the study file.
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Use this log to keep track of assigned participant identification numbers and contact information.
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Regulatory Documentation Checklist
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Use this checklist to assist you in maintaining and organizing study documentation. |
| Staff Signature and Delegation of Responsibility Log |
Use this log to document study staff signature/initials and their research-related responsibilities delegated by the PI. Update this log whenever study staff and/or delegated responsibilities change. Completion of this log demonstrates compliance with Good Clinical Practice (GCP) Guidelines, sections 4.1.5 and 8.3.24.
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| Study Monitoring/Site Visit Log |
Use this log to document any reviews of the study conducted by outside monitors, e.g. sponsor monitors, FDA, OHRP, and/or other site visits. Completion of this log demonstrates compliance with Good Clinical Practice (GCP) Guidelines, sections 5.18, 8.2.20, and 8.3.11.
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Use this template to help keep your regulatory documentation for each study organized and easily accessible. |