Study Management Tools

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.

Tools Instructions
Data and Safety Monitoring Board Charter Template Use this template, which outlines DSMB policies and procedures, when establishing a new Data and Safety Monitoring Board.
Data and Safety Monitoring checklist Use this checklist to develop a comprehensive Data and Safety Monitoring plan.
Device Accountability Log Use this log to ensure adequate record of shipment, receipt, use, and disposition of investigational study devices. Completion of this log demonstrates compliance with FDA regulations, sections 812.140(b)(2).
Drug Accountability Log Use this log to ensure adequate record of shipment, receipt, use, and disposition of investigational study drugs. Completion of this log demonstrates compliance with FDA Regulations, sections 312.57.
Enrollment & Screening Log Use this log to document participant screening and enrollment, informed consent process, basic demographics, and early terminations/withdrawls. Completion of this log demonstrates compliance with Good Clinical Practice (GCP) Guidelines, sections 8.3.22.
External Inspection Prep checklist Use this checklist to prepare for an external audit/inspection to be conducted at a study site (e.g. for-cause or not for-cause audit by QIP, the sponsor, or any federal agency). Completion of this log demonstrates compliance with Good Clinical Practice (GCP) Guidelines, sections 4.1.1.
Human Research Training Log Use this log to keep track of the training status for each member of the study staff. For more information on Harvard Longwood Medical Area Human Research Training requirements please visit our Human Research training page.
Informed Consent/Assent checklist Use this checklist to ensure that informed consent has been appropriately obtained and documented.
International Research Study Start-up checklist Use this checklist when developing recruitment strategies and implementing study start-up procedures for engaging research participants in an international setting.
IRB Submission Log Use this log to document IRB submissions, notifications, required responses, and deadlines. Refer to our IRB Meetings/Deadlines page to determine IRB submission deadlines.
Investigator Self Assessment  Use this checklist to assist in maintaining and organizing study documentation and assisting in maintaining compliance.
Note To File Template Use this 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 documention.
Participant ID Log Use this log to track participant identification numbers and contact information.
Participant Payment Form Section I Section II Section III Use these templates to capture required information for processing participant payments. Alternatively, consider 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.
Regulatory Binder Intended as a hard copy template, use it to help maintain regulatory documentation for each study. Alternatively, use this template as a guide if maintaining such documents electronically.
Reliance Agreement checklist Use this checklist for multisite research to determine whether or not a reliance/cede review (where by one institution relies on another for IRB review and oversight) agreement is appropriate.
Reportable New Information Log Use this log to track and facilatate timely reporting of risks or harms to research participants and/or other reportable events to the IRB.
Specimen and Data Sharing checklist Use this checklist when establishing a new research repository.
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.