Upgrade Changes FAQs
- Navigation and Interface Changes
- SmartForm Changes
- UW Reviewed Study Workflow Changes
- External IRB Workflow Changes
- Managing Study Access Changes
- Existing Study Changes
Navigation and Interface Changes
How has navigation in Zipline changed?
Zipline’s user interface has been simplified and modernized. The biggest changes are to the SmartForms, or the electronic forms that are completed as part of an IRB application. Here are a few of the most significant improvements.
- A left-hand navigator replaced the Jump To menu. The left-hand navigator persists on screen and can be collapsed or opened while you complete the SmartForm pages, depending on your preference. The page you are currently on will always be highlighted in orange to make it easy to see where you are and what you have left.
- The Save, Exit, and Continue buttons were enlarged and relocated to maintain a fixed position in the bottom right corner of the screen as users scroll through the form.
- Slide-in windows replace pop ups when you add a document or person to the SmartForm, helping you focus on the step that needs to be completed before returning to the SmartForm page.
Where did the breadcrumb navigator go?
The breadcrumb navigator is now available when you click the double arrow icon in the top navigation menu.
Where did the back button go?
The back button is no longer available because you can now use the left-hand navigator to jump forward or back to the desired SmartForm page.
I’m seeing an ellipsis button in various locations. What does this mean?
The ellipsis button will generally show you more available options when you click it. For example, in the study workspace, you can click the ellipsis button to see additional tabs for the study.
You’ll also see the ellipsis button when you need to select a person in the system, such as when updating the Principal Investigator or adding a study team member who needs to access Zipline.
What do I need to list on the new Local Research Locations page?
Identify whether there will be any interactions with participants at, or deliberate recruiting of participants from, any of the listed research locations. This is not meant to be a complete list of all possible locations. These locations are specific locations where institutional leadership would like to track human research activities.
If your research location is not listed on the options, select Other. If your research consists solely of obtaining records, specimens, or other information without interacting with the participants, select No direct interaction with participants.
What happened to the Consent Forms and Recruitment Materials page and the Supporting Documents page?
These two pages were combined into one new page. Most studies will now simply include a Local Site Documents page. Multi-site and collaborative studies in which the UW IRB is reviewing the activities of other institutions will also see a Study-Related Documents page. See Filling Out Application for more information about where documents should be uploaded in Zipline.
UW Reviewed Study Workflow Changes
How has the review workflow changed for studies reviewed by UW?
For most UW reviewed studies, the Zipline workflow hasn’t changed.
For multi-site and collaborative studies in which the UW IRB is reviewing the activities of other institutions, the involvement of other institutions is now broken off into a separate site application and reviewed separately from the overall study. See the Single IRB FAQs for more information on this process.
External IRB Workflow Changes
What does “Pending sIRB Review” mean?
This status means that HSD has authorized the use of an external IRB for the study, but HSD has not yet received documentation of the external IRB’s approval for the UW.
HSD now requires a copy of the external IRB’s initial approval letter for UW’s involvement to update the status of studies in “Pending sIRB Review.”
- Studies reviewed by WIRB and Advarra: Researchers do not have to do anything. WIRB and Advarra automatically send approval letters directly to HSD. HSD will upload these to Zipline as they are received.
- Studies review by Trial Innovation Network IRBs: Researchers do not have to do anything. These IRBs automatically provide approval letters to HSD. HSD will upload these to Zipline as they are received.
- Studies reviewed by any other IRB, including Fred Hutch and Seattle Children’s: These IRBs may or may not provide approval letters directly to HSD. If HSD receives the documents directly, HSD staff will upload the document to Zipline. However, the research team should email a copy of the approval letter to email@example.com to ensure that HSD receives the documents.
What does “Active” mean?
“Active” means that HSD staff have recorded the external IRB’s approval of your study in Zipline.
What’s the difference between the options to Create Site Modification and Update Study Details?
These two activities allow you to make changes to different parts of the Zipline SmartForms. There are different processes involved with each application type. See Changing External IRB Studies for more information on when and how to make changes to External IRB studies.
Managing Study Access Changes
Why did the Manage Study Team activity go away?
The Manage Study Team activity in Zipline was a major UW customization to our vendor software. Removing it reduces the cost and effort associated with long-term maintenance of the system. It also prepares the system for possible future integrations with other systems.
What applications now need to have study access managed through the SmartForms?
All applications submitted to the UW system need to manage study access through the SmartForms, whether they are reviewed by the UW IRB or an External IRB (non-UW IRB).
Does the application have to be approved before I can add a PI proxy?
The application does not have to be approved before a PI proxy is designated. However, the PI proxy must be listed on the Local Study Team Members page in the Zipline application.
How do I change study access after the study is approved?
After the study is approved, study access can be changed with a simple administrative modification to the Local Study Team Members SmartForm page. See Managing Study Access for more information.
Existing Study Changes
Why is the documents tab now split into Study Related and Site Related Documents?
The system now splits documents into these 2 categories to better accommodate Single IRB studies. Documents are displayed as Study Related or Site Related Documents simply based on where they were uploaded in the SmartForm application.
Do I need to submit a modification to re-add my study team to the approved application?
No action is needed unless there are changes to the PI, individuals who need to access the application, or the information on the study’s existing ADDENDUM: Study Roles. After the upgrade, the Addendum will remain accessible on the Contacts tab but it cannot be modified. All study team members that had access will continue to have access. If the PI changes, you should submit a CV for the new PI along with a modification. To make other changes to study team roles, contact the HSD team for your study or firstname.lastname@example.org for guidance.
Why does my External IRB study say that it was discarded?
Due to software constraints, the existing applications for these studies were migrated in January 2020 by being copied to a new application. To access current information or update the study, click the link to SITE after “Destination Submission” in the study history.