Monitoring Report for Human Subjects Research - Expedited & Full Board Review

• Please complete this report in its entirety, as it applies to the research protocol being reviewed.

Study Overview

• Study Title

• IRBNet#

• PI Name

• PI Type

  Faculty

  Staff

  Student

• Faculty Sponsor

• Review Type

  Exempt

  Expedited

  Full

• College/Department

  GSSW

  IHAC

  GSPP

  Mordridge

  Sturm

• Type of Study

  Social/Behavioral

  Education

  Other

• Co-Investigator

  Yes

  No

• Collaborative Research

• Is DUA agreement on file?

  Yes

  No

• Total Enrolled To Date

• Total Approved for Enrollment

• Date Monitored

  Date

• Monitor

  Ashleigh Ruehrdanz

  Mary Travis

  Other

• What is the storage location listed in IRBNet?

• Where are the study records physically stored?

• Where are the consent forms stored?

• Do file cabinets have locks?

  Yes

  No

  N/A

• Are computers password protected?

  Yes

  No

  N/A

• Are consent documents stored in an orderly fashion?

  Yes

  No

  N/A

• Additional Comments & Explanations

• How are potential subjects identified?

• Describe recruitment methods stated in the IRB approved protocol

• If recruitment materials are used, specify: (check all that apply) Advertisements (posted) Flyers Web posting Letters

  Select Advertisements (posted) Flyers Web-posting Letters Other No recruitment materials used

  • Advertisements (posted)
  • Flyers
  • Web-posting
  • Letters
  • Other
  • No recruitment materials used

• Is the process for subject recruitment and identification consistent with IRB application and IRB policies?

  Yes

  No

  NA

• According to IRBNet, how will data be recorded to protect privacy?

• Is the research team following this method?

  Yes

  No

• Additional Comments & Explanations

• How many versions* of the consent form are there?

• Consent Version Date

  Date

• Have subjects been enrolled?

  Yes

  No

• Were any invalid consent forms used?

  Yes

  No

  N/A

• Did anyone not approved by the IRB to consent subjects sign as study representative?

  Yes

  No

  N/A

• If yes, was a violation report submitted to the IRB?

  Yes

  No

  N/A

• Does the IRBNet application indicate the inclusion of minors? If yes, was parental permission obtained?

  Yes

  No

  N/A

• Was child assent obtained?

  Yes

  No

  N/A

• Was parental permission waived?

  Yes

  No

  N/A

• Additional Comments & Explanation

  Yes

  No

  N/A

• Is there an eligibility checklist containing inclusion/exclusion criteria?

  Yes

  No

  N/A

• Does each subject file indicate whether the subject was included/excluded appropriately?

  Yes

  No

  N/A

• If any subjects that did not meet eligibility criteria were enrolled, was a protocol violation submitted to the IRB?

  Yes

  No

  N/A

• Additional Comments & Explanation

  Yes

  No

  N/A

• CITI Training Records (Electronic or Hard Copy)

  Yes

  No

  N/A

• Completed data collection measures (surveys, questionnaires, etc.)

  Yes

  No

  N/A

• All notes and/or files of observations recorded

  Yes

  No

  N/A

• Adverse events, protocol deviations, etc.

  Yes

  No

  N/A

• Additional Comments & Explanations

  Yes

  No

  N/A

• Is there documentation of Adverse Event(s)?

  Yes

  No

  N/A

• Was this reported in IRBNet?

  Yes

  No

• Is there documentation of Unanticipated Problem(s)?

  Yes

  No

  N/A

• Was this reported in IRBNet?

  Yes

  No

  N/A

• Is there documentation of Protocol Deviations?

  Yes

  No

  N/A

• Was this reported in IRBNet?

  Yes

  No

  N/A

Description of all adverse events, unanticipated problems, and protocol deviations

• Please describe all adverse events, unanticipated problems, and protocol deviations

• Protocol (current and all prior versions)

  Yes

  No

  N/A

• Consent form (current/approved and all previously approved)

  Yes

  No

  N/A

• Any written material (other than consent form) distributed to subjects

  Yes

  No

  N/A

• Applications and reports submitted to the IRB

  Yes

  No

  N/A

• Correspondence between the PI and IRB

  Yes

  No

  N/A

• IRB approval notices

  Yes

  No

  N/A

• Copies of all adverse events reported to the sponsor and IRB

  Yes

  No

  N/A

• Correspondence between PI and study sponsor

  Yes

  No

  N/A

• Sponsor monitoring log and corresponding reports

  Yes

  No

  N/A

• Investigators’ CVs

  Yes

  No

  N/A

• Participant screening log

  Yes

  No

  N/A

• Participant enrollment log

  Yes

  No

  N/A

• Other

  Yes

  No

  N/A

• Is this protocol a full board review or expedited review requiring board oversight and continuing review?

  Select Yes No

  • Yes
  • No

• What is the expiration date?

  Date

• Number of continuing reviews, to date?

• Indicate continuing reviews on file (date submitted, date approved, IRB letter on file [Y/N])

• Was each continuing review submitted on time?

  Yes

  No

• Was there any lapsed period(s) between expiration date and continuing review approval date?

  Yes

  No

• Were any subjects enrolled during this lapse period?

  Yes

  No

• Were any study procedures done during this lapse period?

  Yes

  No

• Were they approved by the IRB?

  Yes

  No

• Was this an expedited review with "Next Review Date?"

  Yes

  No

• When is next review due?

  Date

• Include a general review of findings, including any recommendations and requirements.