Close-Out Visit Report

Protocol Name/Number:
Visit Date:: / Person (s) contacted during visit/Position:
Investigator:
Site Name and Address:
Monitor (s):
Subject Status: Date of First Subject Enrolled Date of Most Recent Subject Enrolled
# Screened / # Enrolled / # Active / # Completed
# SAEs # CRFs Reviewed: # CRFs Collected

Activity

/

Yes

/ No / N/A

A. Introductions

  1. Were the objectives of the visit explained to the study staff?

  1. Were any materials or forms distributed?

B. Evaluation of Study Staff and Facilities

  1. Was there any change in the study staff since the last visit?
  2. If yes, was the study documentation updated?
  3. If yes, was the staff properly trained for the study?

  1. Was the study staff adequate in number/training for the study?

  1. Has the PI completed his/her obligations to the sponsor/IRB/FDA?

  1. Has the PI/study staff completed required study responsibilities?

  1. Has facility/work area changed since last visit?
  2. If yes, was study documentation updated?
  3. If yes, were the new facilities/equipment inspected?

  1. Are treatments/facilities adequate?

C. Review of Source Documentation and Case Report Form (CRF)

  1. Was source documentation reviewed at this visit?

  1. Is the correct consent form signed and present for each patient?

  1. Is source documentation complete and present for each patient?

  1. Were any unreported Serious Adverse Events discovered?

  1. Were any significant laboratory abnormalities discovered?

  1. Were CRFs reviewed/verified at this visit?

  1. Are the CRF Binders accurate and complete for each patient?

  1. Are all CRFs retrieved at this visit?

  1. Have all CRFs been collected?

  1. Was the PI/study staff available to make corrections?

  1. Were proper CRF correction procedures followed?

D. Review of Study Binder

  1. Is the Study Binder accurate and complete?

  1. Were any Critical Document retrieved at this visit?
  2. Final IRB Report
  3. Other______

  1. Were any study documents retrieved at this visit?
  2. Monitor Log Sheet
  3. Site Signature Log
  4. Subject Screening/Enrollment Log
  5. Drug Accountability Log
  6. Subject Drug Accountability Log

E. Investigational Product and Supplies Accountability

  1. Was study drug stored adequately during the study?

  1. Is the Site Drug Accountability Log accurate and complete?

  1. Are the Patient Drug Accountability Log accurate and complete?

  1. Study drug inventory checked and counted?

  1. Was study drug inventory verified to Logs and CRFs?

  1. Was study drug dispensed properly during the study?

  1. Was the study Blind broken for any patients during the study?
  2. If yes, was it reported to the sponsor?
  3. If yes, was it documented?

  1. Was the study drug returned to sponsor/manufacturer?
  2. If yes, to whose attention was the study drug returned to:______
  3. If yes, what carrier was used for transport:______

  1. Was any study drug previously returned to sponsor/manufacturer?
  2. If yes, was documentation obtained?

  1. Were study supplies stored adequately during the study?

  1. Were study supplies inventoried?

  1. Were unused study supplies appropriately disposed of/returned?

F. General Conduct of the Study
  1. Was the protocol followed, with no significant deviations?

  1. Is the site in compliance with sponsor/FDA requirements?

  1. Are final IRB reporting requirements understood/complete?

  1. Have all previously unresolved issues been addressed?

  1. Was the patient enrollment rate acceptable?

  1. Was the overall progress/performance of the site acceptable?

  1. Are all sponsor commitments to the investigator complete?

  1. Were procedures in the event of contact by FDA discussed?

  1. Was retention of study records discussed?

  1. Where will the CRFs and study records be stored: ______

  1. Who will be responsible for study related queries? Name:______Phone:______

G. Wrap-Up/Investigator & Monitor Meeting:
  1. Collected all CRFs and other data worksheets?

  1. Reconciled product accountability records?

  1. Review of findings conducted with Investigator and study staff?

  1. Was study specific review conducted with the Investigator and staff (procedures/forms, i.e. to notify IRB of completion)?

  1. Was a Question and Answer session conducted?

  1. Was the Monitor Visit Log completed?

Comments:
Finding / Action Item / Resolution

______

Monitor’s Name (please print) Signature Date

______

Investigator’s Name (please print) Signature Date