UW Research

Zipline Glossary

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The chart below contains definitions of many Zipline related terms.

 

Term Definition
Ancillary Review Ancillary reviews allow individuals, departments, and other organizations to give feedback and sign off on a study or follow-on submission in parallel with the IRB review. For example, faculty advisor review is a form of ancillary review.
Collaborative Research See Collaborative Research in the UW Research glossary.
External IRB See External IRB in the UW Research glossary.
Follow-on Submission Follow-on submissions are modifications, continuing reviews, or reports of new information about an existing study.
IRB Coordinator The IRB coordinator in Zipline is the HSD staff member assigned to take the submission through the review process.
IRB Protocol The IRB protocol is the initial IRB application form used for all new studies that are submitted to HSD for UW review.  The IRB protocol focuses on information related specifically to IRB review and is different from a standard study protocol (for example, as used in a clinical trial or to submit to a funding agency).
Multi-site Research See Multi-site Research in the UW Research glossary.
PI Proxy The PI proxy is a member of the study team who the PI has designated as being able to take actions that are normally restricted to the PI, such as submitting studies and responses to requests for more information to HSD.
Primary Contact The primary contact is the study team’s primary contact for receiving communications from the IRB (in addition to the PI). By default, the person who created the study in the system is the primary contact, but this can be changed at any time by a member of the study team. If the primary contact is also a member of the study team, that person should also be added to the list of team members within the study.
Report of New Information The report of new information form is used to submit any issues or relevant new information related to human subjects research. This includes:

  • Qualifying medical problem in research covered by the UW Human Subjects Assistance Program (HSAP)
  • Breach (or risk of breach) of subject confidentiality or privacy
  • Inappropriate access of Protected Health Information (PHI)
  • Incidental incarceration of a subject in a study that the IRB has not approved for the inclusion of prisoners
  • Premature suspension or termination of some or all of the research by the sponsor, researcher, or institution
  • Unanticipated problem
  • Unanticipated adverse medical device effect
  • Serious non-compliance
  • Continuing non-compliance
  • Emergency deviation from IRB-approved procedures made without prior IRB review to eliminate an apparent immediate hazard to a subject or others
  • Continuation of research procedures after IRB approval has lapsed
  • Audit, inspection, compliance-related inquiry, or safety-related inquiry from a federal agency
  • Information that indicates a new or increased risk or safety issue (or a decrease in study benefits)
  • Any Data and Safety Monitoring Board (DSMB) or other study monitoring reports
  • Complaint from a subject that cannot be resolved by the research team
  • Breach (or risk of breach) of subject confidentiality or privacy (e.g. IRB failed to ensure Certificate of Confidentiality was in place before issuing IRB approval)
  • Inappropriate access of Protected Health Information (PHI) (e.g. IRB failed to grant a researcher-requested HIPAA waiver. Researcher subsequently accessed PHI.)
  • IRB Serious non-compliance
  • IRB Continuing non-compliance
Single IRB See Single IRB in the UW Research glossary.
Single-site Study A single-site study is one where all research activities occur at one institution. A study that uses one or more locations at UW or UW Medicine is not considered a multi-site or collaborative study.
SmartForm The SmartForm is the series of forms that Zipline presents you when viewing or entering study information. Study documents, such as the IRB protocol and consent materials, are uploaded to the SmartForm. It is called a SmartForm because the number of forms included may change based on the answers you provide.
Study Roles When listing study team qualifications in the IRB protocol, HSD strongly encourages researchers to describe the general study role rather than a specific individual to reduce the number of modifications needed as the study team changes over time. Examples include “Study Coordinator” and “Co-Investigator.”
Workspace The workspace is what you see when you open a study or other submission. It is your access point for viewing the submission contents and details, including all actions performed on it, editing the submission (for members of the study team), and performing actions on the submission.