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Filling Out Application

Posted By mth13 On December 20, 2019 @ 10:24 am In | Comments Disabled

Take the 2 minute Zipline Online Help Library feedback survey ^[1] to help us improve Zipline support.

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

Prepare HSD Application Form ^[2]
- Applications Reviewed by UW ^[3]
  - IRB Protocol Tips ^[4]
- Applications Reviewed by Non-UW IRB ^[5]
Prepare Other Study Documents ^[6]
- Applications Reviewed by UW ^[7]
- Applications Reviewed by Non-UW IRB ^[8]
Complete the SmartForm ^[9]
- Basic Steps ^[10]
- Tips ^[11]

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 ^[12] 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 ^[13].

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 ^[3]
- IRB Protocol Tips ^[4]
Applications Reviewed by a Non-UW IRB ^[5]
Delayed Onset Human Research Determinations ^[14]

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

Use the shorter “No Contact with Subjects” version of the form if you are doing specimen/data research involving no interaction with subjects.
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.
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.
Make use of the instructions and examples embedded within the form to help answer questions you may have about completing various sections.
If you think that your research may be exempt from human subjects regulations or not be considered research with human subjects, only answer the marked 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.
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.
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.
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 ^[17] 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 ^[18] 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 IRB or HSD ^[6]
Applications Reviewed by a Non-UW IRB ^[8]

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 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 (Do not include for human subjects determinations or exemptions) 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 (Do not include for human subjects determinations or exemptions) Site Specific Recruitment materials PI’s Curriculum Vitae (CV) IRB 101 ^[19] Training Certificate (only required for student and resident PIs) 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 ^[17] 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 ^[20] and other study documents ^[21] 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 ^[22] as needed until it is ready to be submitted to HSD for review.

Basic Steps ^[10]
Tips ^[11]

Basic Steps

1. Click Create and then select Create New Study from the menu

NOTE: If you do not see the Create New Study button, click the Dashboard link

Create menu

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 ^[17] form should be uploaded on the External IRB SmartForm page.

screenshot of the external IRB question

UW Review Only: Attach the completed IRB Protocol ^[16] form to the Basic Information Page

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 ^[23] complete the Submit activity ^[24].

Tips

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.
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.
Note that some of the questions contain branching logic. The SmartForms may change depending on your responses to key questions.

Next Step ^[25]

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