Creating a new study

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This page has been excerpted from the HSD website, which walks you through the steps of creating a new study using the Zipline submission system. You can also download this page here. Media: ZiplineGuide.docx


Zipline Introduction[edit | edit source]

Zipline is the new University of Washington IRB submission system that consists of a series of web-based SmartForms containing a number of attachments with additional study information. Most of the information about your study will be added via the uploaded attachments, including the completed IRB Protocol form. There are two versions of the form: the standard version for most research, and one for research involving no interaction with subjects. You must attach one of these forms for all submissions that are requesting review (Even if you are requesting exempt review) from the Human Subjects Division (HSD) and the UW IRB.

Before you begin[edit | edit source]

HSD recommends that you prepare your study documents, including the completed IRB Protocol form (see above) before you create your study in Zipline. Important note: Your study cannot be saved in Zipline until the IRB Protocol Form is uploaded. See a list of other common Zipline attachments that may be necessary for your application. You can also search for and download the forms and templates.

You can edit the study and add or update attachments until you submit it for review, but you must have the IRB Protocol Form uploaded before you can save the study in Zipline. See edit submission for further instructions on editing the study and adding/updating attachments.

If the study you are creating is very similar to another study you already have in Zipline, you may be able to copy the original study and make revisions to the copy.

Zipline Workflow

When you create a new study, it is in the pre-submission (dark blue) state until it is submitted to HSD. The following walks you through the process of creating a new study and is followed with links to your next steps.

Creating a new study[edit | edit source]

After logging into Zipline, click Create New Study under My Current Actions:

Currentactions.png

You will be redirected to the first page of the SmartForm. Complete all required and applicable questions.

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Attach the completed IRB Protocol Form. Click continue to move to the next SmartForm page. (Note: Clicking continue on the Basic Information SmartForm page or clicking Save will save your new study in Zipline.)

Continue through the SmartForms, completing all required questions and any other applicable questions, and uploading any additional study documents. See Zipline attachments for more information about where common documents should be uploaded in Zipline. (Note: You can also use the Jump To menu to navigate to any SmartForm page.)

When you have finished, click Finish to exit the SmartForm and go to the study workspace:

Studyworkspace.png

From this page you can add a faculty advisor to review the study, manage the study team, assign a PI proxy, edit the study, and submit to HSD.

Next steps[edit | edit source]

Faculty Advisor Review[edit | edit source]

If you are a student, you are required to have a faculty advisor review your study. This is completed with the Manage Ancillary Reviews activity. The faculty advisor review may occur concurrently with HSD review; however, final IRB approval will not be issued until the required faculty advisor review is completed. See Instructions: Send Study for Faculty Advisor Review

Manage Study Team[edit | edit source]

Add the study team to the application. If you are changing the individuals that are acting as members of the study team, it does not require a study modification and can be done at any time during the life of the study. However, changes to the study roles do require a study modification. See Instructions: Manage Study Team

Editing the Study[edit | edit source]

Edit the study as needed. See Instructions: Edit Submission

Assign a PI Proxy[edit | edit source]

You can only assign a PI proxy if your study is being reviewed by a UW IRB. The PI can assign a proxy who can perform all actions restricted to the PI, such as submitting the application and copying a previous study. See Instructions: Assign a PI Proxy

Submit to HSD[edit | edit source]

Submit your study to HSD for review. This must be completed by the PI or the PI proxy. Submitting your study sends the item to HSD for review and changes the submission state from pre-submission to pre-review. See Instructions: Submit to HSD