Study Closeout Form

Study Closeout Form

You must submit a Study Closeout Report for ALL types of studies. The report updates the IRB on the conduct and outcomes of the study, including any risks or problems that may have arisen since the last continuing review that may need to be disclosed to the study participants or others.

Do NOT close out a study if any of the following conditions apply. These studies must remain active and receive ongoing IRB review and approval.

Any of the following activities are ongoing: Local enrollment, Local research-related interventions or Local participant follow-up.

Data analysis or manuscript preparation that involves use or access to individually identifiable information.

Biological specimens containing individually identifiable information are being maintained in a repository that has been approved as part of this study or upon which analysis or research continues. If specimens were transferred to a separate repository that has ongoing IRB approval, then the study may be closed.

You have not received permission from the PI to close the study with the IRB.

Section I. Background Information
Title of study *
Protocol number *
Principal Investigator/Faculty advisor *
Co-Investigators *
Student Investigators and Research Personnel *
Initial date of IRB approval Initial date of IRB approval * / MM / DD YYYY
Project duration *
Section II. Enrollment
1. Total number of participants enrolled *
2. Number of participants that discontinued research for any reason. *
List reasons.
3. Total number of participants who completed the study. *
Section III. Study Assessment
1. Have there been any complaints received from anyone about the study? (Participants, Parents/Guardians, Community Members, Staff, etc) *

1. Have there been any complaints received from anyone about the study? (Participants, Parents/Guardians, Community Members, Staff, etc) Yes No
2. Did the anticipated risks or benefits change during the study *

2. Did the anticipated risks or benefits change during the study Yes No
3. Was your study audited or monitored by any other agency? *

3. Was your study audited or monitored by any other agency? Yes No
If yes, please list below.
4. Are there any publications planned regarding this study? *

4. Are there any publications planned regarding this study? Yes No
If yes, list references to publications.
Section IV. Reason for study closure.
Check reasons for study closure. *

Check reasons for study closure. Data analysis is complete Interim analysis determined study is not safe or efficacious No funding, time constraints or personnel to do the study Other, please explain Other, please explain
As the Principal Investigator / Co-investigator on this project, my signature confirms that: 1. The study was conducted in accordance with all relevant policies and regulations that govern research involving human participants. 2. I agree that the study should be closed. *

Draw or Type

I understand this is a legal representation of my signature. Clear

Full Name

I understand this is a legal representation of my signature.