A Project Closure Form notifies the IRB that all human subjects research has ended, and IRB approval is no longer needed. When a study ends, is closed, or canceled for any reason, the Principal Investigator (PI) or their HawkIRB delegate must submit a Project Closure Form. Before the PI leaves the University of Iowa, they should submit a Project Closure Form or a Modification form to change the PI (if research activities will continue at the UI).  

Take Care not to Close the Project too Soon!   

Once a Project Closure Form is processed, no further research-related activity can occur. The project no longer has IRB approval to collect or work with identifiable data or coded/linked data that are connected to identifiable private information. And the project no longer has IRB approval for any contact with subjects for research purposes.  

Projects should NOT be closed unless all of the following are completed:  

  1. Protocol indicated research activities, including interaction with subjects, collection of data or specimens and any communications with subjects for unblinding or sharing results.  

  1.  Collection of data about subjects, even when no subject contact is necessary.  

  1.  “Cleaning” of data 

  1.  Analysis of identified or linked data for research purposes or during the publication process, including additional analyses that may be required after submission of a manuscript for publication.  

  1. Any other research use of the data which involves access to identified or linked (coded) data or specimens collected during the conduct of research. 

  1. The PI of a project is leaving the University of Iowa and no other investigator is taking over the project. 

  1. Results are reported on the ClinicalTrials.gov website (if this is required based on FDA regulations (e.g., Applicable Clinical Trial) or federal funding (e.g., NIH clinical trials). 

Responsibilities After Study Closure 


Your research records may be audited or monitored at any time during or after IRB approval of a project or after the study has been formally closed with the IRB. 

University of Iowa Research Data: 

In accordance with the University of Iowa’s copyright policy (Operations Manual Section V(30.4), research data generated as part of a University of Iowa research study is owned by the University.  All research data policies remain in effect even after the research has ended.  For additional information regarding the research data policy and any requirements for data leaving the University of Iowa, visit the Division of Sponsored Programs website under Data Use Agreements.   

Record-Keeping/Retention Requirements:

Federal and University policies require that all research records be maintained fora period of three (3) years following the close of the research project.  For research that involves drugs or devices seeking FDA approval, the research records must be kept for a period of three years after the FDA has taken final action on the marketing application.  For research that involves Protected Health Information (PHI) under HIPAA, the research records must be kept for a period of six (6) years following the close of the research project. For research conducted at Veterans Administration Health Care System (VAHCS) or using VA resources, that is overseen by IRB-03, all research records must be stored indefinitely.  

Follow These Steps to Submit a Project Closure Form 

  1.  Log in to HawkIRB . 
  2. In the “Projects” section of the Principal Investigator’s (PI’s) HawkIRB inbox, click on the IRB number of the study you wish to close. You will be routed to the Project Summary page. 
  3. In the “Create Form” box in the upper left, click on “Project Close Form”. 
  4. Complete the form to indicate the number of subjects enrolled and the reason the project is closing. Click “Continue/Save” and add any attachments.  
  5. If you need to come back to the form before submitting it, click one of the “Save” buttons at the bottom of the screen.  The Project Close form will be saved in the Draft Forms of the PI’s inbox. 
  6. Click “Continue/Save” to get to the final submission page and then click “Submit Form.” 
  7.  The project is closed as soon as you submit the closure form to the IRB. 

Project Closure Memo 

After project closure forms are fully processed, HawkIRB will send an automated email to the PI, their HawkIRB Delegates and any contact persons on the research team stating that the project was formally closed. The Project Closure memo can be accessed via a link in the email message or on the Project Summary page, under the Approval tab. The memo contains important information about record retention and research data requirements. 

Continuing a Project if Closed by Mistake 

Once the Project Close form is fully processed, the study no longer has IRB approval. No further research related activity can occur after the project is closed. There is no way to reverse a project closure form. You must submit a New Project form and obtain IRB approval if you would like to continue the research. 

Error Message When Creating a Project Close Form 

If you try generating a Project Close form and get this message: "A form exists for this project - no new forms can be created", that typically means there is a draft form started for this project in the PIs HawkIRB inbox. It could be a Modification form, Continuing Review form, Biennial Review form, Reportable Event Form (REF), or Project Close form. You may not close a project for which there is a draft form. You must either complete the draft form or remove the form from the PIs inbox if it will not be completed. 

Accessing a Closed Project in HawkIRB 

After the project is closed, the project no longer appears in the PIs inbox. To access a closed project, update the filter in the Projects section of the PIs inbox to change project status from “Open” to “Any.” 

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