Closing a Study

  1. When should I close a study?
  2. How do I submit a project closure form?
  3. I completed a project closure form by mistake.  I would like to continue my study.  Can this form be withdrawn?
  4. I tried clicking on a link to close my project, but I get this message: "A Project Close Form exists for this project - no new forms can be created".  What can I do?

 1.  When should I close a study?

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

  •  Protocol indicated research activities including interaction with subjects and collection of data or specimens 
  •  Collection of data about subjects even when no subject contact is necessary 
  •  “Cleaning” of data 
  •  analysis of identified or linked data for research purposes or during the publication process 
  •  any other research use of the data which involves access to identified or linked (coded) data or specimens collected during the conduct of research

When a study ends, is closed, canceled for any reason, or is prematurely completed you must complete a Project Closure Form.   A Project Closure Form serves as notification to the Human Subjects Office that IRB continuing review of the study is no longer needed. 

Take care not to close the project too soon!  Once a Project Closure Form is processed, no further research related activity can occur. This means no data (either identifiable or coded/linked) may be collected or used for any subject. And any contact with subjects for research purposes will no longer be allowed. 

ADDITIONAL RESOURCES:

 2.  How do I submit a project closure form?

  •  Log into your HawkIRB inbox here.
  •  Under Projects, click on the IRB number of the study you wish to close. You will be routed to the Project Summary page
  •  Under Create Form, click on Project Close Form.
  •  Complete the form and click on Submit. (If you need to come back to the form before submitting, click on Save.  You can then access it again from the Draft Forms in your inbox.)
  •  The project is closed as soon as you submit the closure form to the IRB.

 3.  I completed a project closure form by mistake. I would like to continue my study. Can this form be withdrawn?

The project closure form is effective as soon as it is submitted; once it is submitted the study is considered closed. No further research related activity can occur after the project is closed. There is no way to withdraw the project closure form. If you would like to continue your study, you must submit a new project application and obtain IRB approval before continuing your research.

 4.  I tried clicking on a link to close my project, but I get this message: "A Project Close Form exists for this project - no new forms can be created".   What can I do?

  •  Log into your HawkIRB inbox here.
  •  Under Draft Forms, you should see this project listed. The form Type (at the far right) should be close.
  •  Click on the project title to access the closure form.
  •  Complete the form and click on Submit. (If you need to come back to the form before submitting, click on Save.  You can then access it again from the Draft Forms in your inbox.)
  •  The project is closed as soon as you submit the closure form to the IRB.