Indiana University Health Bloomington Institutional Review Board (IRB)
Continuing Review/Closeout Form Instructions
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When completing the continuing review/close out forms, please keep the following things in mind:
1.
The forms must be completed in MS Word or similar word processing software.
2.
Ensure that a response is provided for ALL items, even if you are closing the study – DO NOT LEAVE
ITEMS BLANK. If items are left blank, the form may be returned to you for additional information, which could cause delays in processing your continuing review and result in your study expiring.
3.
Additional pages may be added as necessary (Please note at the appropriate location on the continuing review/closeout form when attachments have been provided).
4.
Do not include these instructions with your continuing review/closeout submission to the IRB.
5.
If you have questions about completing the forms, please contact the IU Health Bloomington IRB
Office:
 Bloomington: (812) 353-2847 or cholladay@iuhealth.org
6.
Submissions to the Indiana University Health Bloomington IRB must be sent to the IRB Office. Please visit the IU Health Bloomington IRB Office website for more information.
Depending on the current status of the research project, you should complete the appropriate form:
1.
Ongoing – Open to Enrollment: studies are open for active enrollment of new subjects
2.
Ongoing – Closed to Enrollment
3.
Ongoing – Data Analysis Only
4.
Closeout Report
Section III: Subject Summary.
Please consider the following definitions when completing the subject summary table. Please note that the numbers provided in the Subject Summary Table should add up correctly. If not, please provide more information in the space provided under the table.
1.
Consented: Provide the total number of subjects (at the local site) who signed an informed consent document since the last review. This number should include any subjects who signed a consent document and were either found to be ineligible for the study or withdrew from the study prior to completion. Be sure to also account for the number of screen failures and withdrawals in the appropriate table field. NOTE: If the IRB approved a waiver of consent for the study, the
“consented” number should reflect the number of records, specimens, etc. that have been reviewed or collected.
2.
Failed Screening: Provide the total number of subjects who signed an informed consent document and were then found to be ineligible for the study (during or after the screening process). NOTE: If the IRB approved a waiver of consent for the study, the “failed screening” number should reflect the number of records, specimens, etc. that were found to be ineligible.
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3.
Withdrawn: Provide the total number of subjects who signed an informed consent document
(unless the IRB approved a waiver of consent) and subsequently discontinued participation prior to their completion of the study. This discontinuation can be initiated by the PI, sponsor or by the subject and may occur at any point during the study, but prior to study completion. Withdrawn also includes deaths if death is not an endpoint of the study, in which case the death should be reported as a completion.
4.
Active: Provide the total number of subjects who signed an informed consent document (unless the IRB approved a waiver of consent) and are either awaiting treatment or study intervention/interaction or are actively receiving treatment or intervention/interaction or being followed.
5.
Completed: Provide the total number of subjects who signed an informed consent document
(unless the IRB approved a waiver of consent) and have completed the planned protocol. This does not include any subject who is considered “withdrawn” or has been lost to follow-up.
Completed includes deaths if death is an endpoint of the study.
Section IV: Ethnic/Racial Reporting Required For Federally-Sponsored Studies. Pursuant to the Office of
Management and Budget (OMB), Federal Register Notice (October 30, 1997), all federally-sponsored studies must report data on race and ethnicity for all subjects enrolled in human subjects research. This includes, but is not limited to, studies sponsored by the NIH or CDC and studies or sponsored by the VA or involving VA subjects. Please provide that total number of subjects in each category.
Section V: Summary of Events:
1.
Events that require reporting (e.g. unanticipated problems and noncompliance that occurred since the last review) must be provided in summary form.
2.
Complaints: Please explain any complaint made by a subject as part of the research (e.g. could include complaints such as “the investigator was late to my appointment” or “the clinic was dirty”).
This clarification, which was provided by the Office for Human Research Protections (OHRP), is because these and other complaints could be indications of larger problems.
Checklist of Required Revisions at the Time of Continuing Review
Please read the instructions below to ensure that you submit complete paperwork with your continuing review/closeout report. Otherwise, you may experience delays in your study receiving approval.
If the study’s status is Ongoing – Open to Enrollment, you must include an up-to-date summary safeguard statement.
If the study’s status is Ongoing – Open to Enrollment or Ongoing – Closed to Enrollment and participants are still receiving research-related interventions or interactions, or participants have completed researchrelated intervention or interaction but long-term follow-up continues, you must include the most current protocol with the renewal submission.
CITI Education: Beginning September 1, 2012, all investigators participating in human subjects research must complete the required CITI modules. After this date, studies cannot be approved until all investigators/co-investigators have completed and passed the appropriate modules. Please visit http://researchadmin.iu.edu/REEP/reep_citi.html
for more information.
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SPECIAL CIRCUMSTANCES: The below requirements only apply to research studies that remain open to enrollment or closed to enrollment but planning to reconsent subjects.
FINANCIAL INTEREST STATEMENT. The informed consent document must include the financial interest statement. Please see the Informed Consent Template for more information.
CONFLICT OF INTEREST. Declaration of any financial conflict of interest must be included in the informed consent and appropriate COI documentation must be on file in the IRB Office.
STUDIES INVOLVING GENETIC INFORMATION: if the study involves genetic testing or the tracking of a particular disease or disorder in an individual’s family, the informed consent document must include the statement regarding GINA, as applicable. Please see the Informed Consent Template for more information.
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