Creating a New Study

You can create a new study for IRB review by entering information into a series of online forms. The number of forms included may change based on the answers you provide. The forms tell you where to attach files to provide supporting information. The forms may contain required information identified by a red asterisk (*), you cannot proceed without providing that information. A required attachment to the Basic Information form is a Word document that describes the research: either the Protocol Template or the Not Human Subjects Research Determination Request. Additional documents should be attached to the forms where appropriate, such as recruiting, consenting and debriefing subject material. It is recommended that these documents be prepared prior to creating the new study; templates and guidance are available on your IRB website.  

The simplest approach is to follow the forms in order, answering the questions and clicking Continue to save your information and move to the next form. When you reach the end of the series of forms, click the Save & Exit button.

To create a new study for review:

  1. From My Inbox or IRB pages (linked in the top menu), click Create New Study
    Button Image for Create New Study

     
  2. Fill in the applicable boxes, answer the questions, and attach appropriate documents. 
     
  3. Click Continue to move to the next form.
    Image of SmartForm menu highlighting continue button

     
  4. Click the ‘jump to’ menu to go to a specific section (be careful to save before jumping to another page).
    Image of the SmartForm jump to menu

     
  5. To save or exit the SmartForm at any time, click on “Save” and “Exit” button in the top toolbar. Exit will take you to that submission’s workspace.
    Image of the SmartForm menu highlighting save and exit

     
  6. When you reach the final page, click Save & Exit to exit the study.
    You can continue to edit the study until you submit it for review. See Editing a Submission.

Important! The study has not been submitted for review yet. For instructions, see Submitting the Study for Review.

TIPS

If a study team member plans to create a new study which is similar to a previous one, the PI on the previous study can complete the Copy Submission activity to create a partially completed form to update and further edit prior to submission to the IRB for review.

Documents can be added to SmartForm spaces by dragging and dropping them from a location on your computer.  There are two different ways to do this, depending on the prompt provided on the form. 

Drag and drop options

A continuing review, modification, or RNI (reportable new information) submission can be handled similarly to a study. For differences, see Creating a Follow-On Submission after Study Approval.

Reference the Library (linked on the left side of any workspace screen) any templates/forms that are requested within the SmartForm, along with guidance materials.

A red asterisk (*) precedes each question that requires an answer. If you cannot answer a required question at this time, or if you need to stop and continue at a later time, you can save and return to the submission later. You must provide all required information before you can submit the study for review.