Logs

Tools Instructions
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.
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.
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.
Participant ID Log Use this log to track participant identification numbers and contact information.
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.
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.