Monitoring Visit Report - DOC by uD5AFN

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									                                     Monitoring Visit Report

Protocol Name/Number:



Visit Date::                                                    Person (s) contacted during visit/Position:

Investigator:

Site Name and Address:




                                                                Monitor (s):




Type of Visit:            Routine/Scheduled

                          Unscheduled/For Cause:

          ______________________________________________________

                          Study Close-out (Please √ Reason)                    Completion          Suspension

                Termination


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. Verification of Regulatory Documents

     1.        Protocol

     2.        Signed Protocol Signature Page

     3.        Protocol Amendment(s)

     4.    Signed Protocol Signature Page for
          Amendment(s)

     5.        Investigator Drug Brochure

     6.        FDA approved package label/insert

     7.        Form FDA 1571
ACTIVITY                                            YES   NO   N/A

   8.   Form FDA 1572

   9.   Revised Form FDA 1571 (s)

   10. Revised Form FDA 1572 (s)

   11. CVs of All Investigator(s)

   12. Medical Licenses for All Investigator(s)

   13. Original IRB Approval Letters for Protocol
       and Consent

   14. IRB Annual Report

   15. IRB Annual Re-approval Letter (s)

   16. IRB Approved Informed Consent

   17. IRB Approved Revised Informed Consent
       (s)
   18. IRB Approved Patient Advertisement/
       Recruitment Tools

   19. Safety Updates/Reports submitted to IRB

   20. IRB Multiple Assurance
       (No.____________)

   21. IRB Correspondence File

   22. General Correspondence File

   23. Monitor Site Visit Log

   24. Staff Signature Log/Delegation of
       Responsibility Log

   25. Subject Screening/Enrollment Log

   26. Laboratory Licensure/Accreditation

   27. Laboratory Normal Values

   28. CV for Laboratory Director

B. Financial Documents

   1.   Confidentiality Agreement

   2.  Clinical Investigation Agreement and
   Budget

   3.   Letter of Indemnification
ACTIVITY                                             YES   NO   N/A

C. Workload/Facility Status

   1. Has Investigator accepted new studies
   since last visit?
   2. Is Investigator properly supervising other
   personnel?
   3. Is Investigator devoting enough time for the
   study?
   4. Any changes in site key personnel since
   last visit?
   5. Has facility/work area changed since last
   visit?
   6.   Are treatment facilities adequate?

D. Subject Verification and CRF Review

   1.   Is subject enrollment adequate?
   2.   Is subject enrollment log up to date?
   3.   Do subjects meet eligibility requirements?
   4. Have subjects signed informed consent
   form?
   5. Are CRFs completed properly and on a
   timely basis?
   6.   Are CRFs legible, accurate and complete?
   7. Are source documents legible, accurate
   and complete?
   8. Were source documents checked for CRF
   reviewed?
   9.   Were the data collected verifiable?
   10. Were there any inconsistencies noted in
   reviews?
   11. Were study procedures done in accordance
   with the protocol?
   12. Is follow-up current and properly recorded?


   13. Are dropouts/withdrawn subjects
   documented?
   14. Have adverse events been adequately
   documented?
   15. Have there been any protocol violations
ACTIVITY                                             YES   NO   N/A
   since last visit?
   16. Do site records match up with Sponsor
   records?

E. Investigator/Monitor Meeting

   1.   Reviewed all significant findings?
   2.   Discussed all action items?
   3. Reviewed regulatory issues specific to
   visit?
   4. Reviewed corrected items from previous
   visit?
F. Investigational Product Accountability
   1. Are product storage facilities adequate,
   secure?
   2. Has location of product storage changed
   since last visit?
   3.   Product forms complete and up to date?
   4.   Product inventory checked and counted?
   5. Accountability Form complete and up to
   date?

G. Overall Review of Study Status

   1.   Is maintenance of records complete?
   2. Is site in compliance with protocol and IRB?

   3. Are participants accruing within timelines?
   4. Is additional clinical/technical training
   required?

H. For Close-out Visits Only:

   1. Collected all CRFs and other data
   worksheets?
   2. Reconciled product accountability records?
   3. Investigator advised on unused product
   return?
   4. Investigator advised to notify IRB of
   completion?
   5. Investigator advised of records retention
   policy?
   6. Investigator advised of records retention
ACTIVITY                                          YES              NO         N/A
   policy?


Comments:
Finding                          Action Item              Resolution




____________________________                   ________________________________
Monitor’s Name (please print)                  Signature
Date

____________________________                   ________________________________
Investigator’s Name (please print)             Signature
Date

								
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