UW Research

Filling Out Application

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Once you have determined the appropriate path for your application, you are ready to begin. There are 3 main steps.

  1. Prepare HSD Application Form
  2. Prepare Other Study Documents
  3. Complete the SmartForm

If the study that you are creating is very similar to another study you already have in Zipline, you may be able to save time by copying the original application and making revisions to the copy.

If you have already created a Zipline application but have not yet submitted it, you can continue to edit your application.

Prepare HSD Application Form

The first step for any new Zipline application is completing the appropriate HSD application form to upload to Zipline. The appropriate application form depends on which IRB will be reviewing the study. Because documents are edited throughout the life of the application to reflect the most current information, the forms are provided in Word format.

Applications Reviewed by UW

The IRB Protocol form must be attached for all applications that are requesting review from the Human Subjects Division (HSD) and the UW IRB. There are two versions of the IRB Protocol form:

The same two IRB Protocol forms and general process are used for all new UW IRB reviewed studies in Zipline.

IRB Protocol Tips

  1. Use the shorter “No Contact with Subjects” version of the form if you are doing specimen/data research involving no interaction with subjects.
  2. The IRB Protocol form is updated regularly. When completing a new application, make sure that you are using the most recent version, which is available in Zipline and on the HSD website.
  3. The IRB Protocol is broken down into many sections based on topic. The first time you complete the form, scan through the questions so that you know what questions are coming and don’t duplicate information.
  4. Make use of the instructions and examples embedded within the form to help answer questions you may have about completing various sections.
  5. If you think that your research may be exempt from human subjects regulations or not be considered research with human subjects, only answer the circled questions on the IRB Protocol. If HSD staff determine that additional information is needed during review, they will simply ask you to complete additional questions.
  6. You can reference other documents, such as grant applications or study protocols, if they provide the needed information in non-technical language and the referenced document is attached to the electronic application.
  7. The IRB Protocol is a living document. It should reflect complete and accurate information about your research activities, and it will change over time as HSD asks for more information during the review and as you modify your study over time.
  8. When editing the IRB protocol in response to an HSD request or a study modification, enabling tracked changes facilitates our review of your application.

Applications Reviewed by a Non-UW IRB

The REQUEST External IRB Review form is required for all studies that are requesting to seek review from a non-UW IRB.

Delayed Onset Human Research Determinations

To request a Delayed Onset Human Research (DOHR) determination, complete the APPLICATION Determination, Delayed Onset Human Research and follow the instructions on the form.

Prepare Other Study Documents

In addition to the HSD application form, we recommend preparing all other study documents before creating your application in Zipline. The study documents should be uploaded in the application SmartForms. Required documents and where they should be uploaded are listed below.

Applications Reviewed by UW

Study staff are responsible for uploading these documents to the Zipline application, if applicable:

Attachment Type SmartForm Location
  • IRB Protocol Form (Required)
Basic Information SmartForm Page
  • Grant Applications or other Funding
Study Funding Sources SmartForm Page
  • Study Drug Information (such as investigator brochures or IND information)
Drugs, Biologics, Supplements, and Botanicals SmartForm Page
  • Study Device Information (such as device instructions, IDE documentation, or the risk determination by the FDA and/or sponsor)
Devices SmartForm Page
  • Generic Templates for Consent Forms, Assent Forms, and Parental Permission Forms that will be supplied to other sites for adaptation or use
  • Generic Templates for Recruitment Materials
  • Other documents that apply to the study as a whole and not just the UW site, such as the study protocol, data collection forms, and any required supplements
Study Related Documents Page (Only available for multi-site or collaborative studies in which the UW is reviewing for another institution)
  • Site Specific Consent Forms, Assent Forms, and Parental Permission Forms
  • Site Specific Recruitment materials
  • PI’s Curriculum Vitae (CV)
  • Other documents specific to the site that have not already been provided
Local Site Documents Page

HSD staff may upload the following documents to your application, if applicable:

  • Signed IRB Reliance Agreements
  • Signed Individual Investigator Agreements
  • Genomic Data Sharing Certifications
  • Prisoner Certification Letters
  • Local Context Information Sheets
  • Reporting Letters sent by HSD to federal agencies
  • Acknowledgement of Certificate of Confidentiality (Only NIH and CDC funded studies)
  • Radiation Safety Renewals (with continuing review only)

Applications Reviewed by a Non-UW IRB

See Section 5: Required Attachments in the Request External IRB Review form for a list of documents that should be included with an application requesting review by a non-UW IRB.

Complete the SmartForm

Creating a new study in Zipline involves completing the web-based SmartForms, including document uploads. You’ll need to upload your completed HSD application form and other study documents throughout the SmartForms. If your study is being reviewed by UW, you must upload your IRB Protocol form to the first SmartForm page in order to save your application!

The basic process for creating a new study is the same for all applications. After creating the study, you or other members of the study team who are listed on the Study Team Members SmartForm page can continue to edit the application as needed until it is ready to be submitted to HSD for review.

If the study that you are creating is very similar to another study you already have in Zipline, you may be able to save time by copying the original application and making revisions to the copy.

Basic Steps

1. Click Create New Study

  • NOTE: If you do not see the Create New Study button, click the My Inbox link

screenshot of the Create New Study button

2. Fill in the applicable boxes and answer the questions on the first page of the SmartForm

  • NOTE: Some of the questions contain branching logic, so the forms may change depending on your response to the question.
  • Requests for Non-UW Review Only: Indicate “Yes” to the question asking if you are requesting authorization for an external IRB to review the study instead of the UW IRB. The Request External IRB Review form should be uploaded on the External IRB SmartForm page.

screenshot of the external IRB question

  • UW Review Only: Attach the completed IRB Protocol form to the Basic Information Pagescreenshot of the IRB protocol question

3. 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. For studies reviewed by UW, a document must be attached in the IRB Protocol question before the system will allow you to save.

screenshot of the continue button

4. Continue through the SmartForms completing all required questions and any other applicable questions, and uploading any additional study documents

5. When you reach the final page, click Finish to exit the SmartForm and go to the study workspace

  • NOTE: Click Exit at any time to leave the SmartForm and go to the study workspace

screenshot of the finish button

After exiting the SmartForm, you are in the study workspace:

IMPORTANT: The study will remain in Pre-Submission state until the PI or a PI Proxy complete the Submit activity.

Tips

  1. Red asterisks indicate that a question is required by the system. You will not be able to submit the application until a response is provided.
  2. Many questions have a help bubble. Click the help bubble to get more information about how to answer the question. If you still have questions about how to respond, contact HSD for additional help.
  3. Note that some of the questions contain branching logic. The SmartForms may change depending on your responses to key questions.

Next Step

Edit Study

After a study is created, the PI, any PI proxies, primary contact, and other study team members may continue editing the application until the Submit activity has been completed. Multiple users may edit the application at the same time.

To edit:

1. In the study workspace, click Edit Study in Next Steps

Edit Study Button under next steps

2. Make any needed changes to the SmartForms, including adding any new documents and updating any previously uploaded documents

3. Save and Exit the SmartForm to return to the study workspace