Use the below tools and customize as appropriate. Some tools may have been protected with the password “qip” to ensure the form-full features function properly.
Check our website regularly for new and updated tools. Submit your request for a new tool here.
|Adverse Event Log||Use this log to ensure tracking and timely reporting of adverse events to the IRB|
|Enrollment Log||Use this log to document participant enrollment, informed consent process, basic demographics, and early terminations/withdrawals.|
|Human Research Training Log||Use this log to keep track of the training status for each member of the study staff on HSPH, HMS or HSDM protocols. For more information on Harvard Longwood Medical Area Human Subjects Training requirements please visit our Human Research training page.|
|IRB Submission Log||Use this log to document HSPH, HMS, or HSDM IRB submissions, notifications, required responses, and deadlines. Refer to our IRB Meetings/Deadlines page to determine IRB submission deadlines.|
|Note To File Template||Use this Note to File Template to document any discrepancy, deviation, or missing material(s) in the study file so as to provide a complete history of the protocol. Retain this note with your regulatory document.|
|Participant ID Log||Use this log to keep track of assigned participant identification numbers and contact information.|
|Investigator Quality Improvement Checklist||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.|
|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.|
|Regulatory Binder||Intended as a hard copy template, use it to help maintain your regulatory documentation for each study. If you prefer to maintain such documents electronically, use this template to guide how best to organize your documentation.|
|Participant Payment Form Section I Section II Section III||Use these template forms to capture required information for processing participant payments. Alternatively, investigators are encouraged to develop their own protocol-specific formats, and can contact QIP for assistance. Refer to this Flow Chart to determine what form(s) is/are appropriate for your protocol. For more information visit the Harvard University Financial Policy on Human Subjects Payments. For more information about this policy or processing human subjects payments, contact the Office of Financial Services: Sharon Reine or Gina Sanchez or the University Office of the Controller at 617-495-4532.|