UW Research

Submission Types and States

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Submission Types

The Zipline system allows the submission types listed below. Note that each submission is automatically assigned a unique ID number. The ID number prefix indicates the type of submission. However, there is not a relationship between a follow-on submission’s ID number and the parent study’s ID number.

Type Description Zipline ID Prefix
Initial Used for:

  • All new studies that are requesting review from HSD and the UW IRB, including single site studies occurring only at UW and multi-site or collaborative studies involving other institutions
  • All new studies that are requesting review from a non-UW IRB
 STUDY
Site For multi-site or collaborative studies reviewed by the UW IRB, site submissions document the UW IRB’s review of non-UW sites that are involved in the research.

Site submissions document the study details specific to a particular institution, such as institution-specific consent forms.

*Also applies to all external (non-UW) IRB studies that were created prior to 1/7/2020.

 SITE
Modification UW Reviewed Studies:

Used to submit a change to a previously approved study or site

  • “Follow-on” submission from the study or site
  • Can be combined with a continuing review for studies
  • 2 types of modifications
    • Study Team Changes (not including PI)
    • Other Changes

Studies Reviewed by a Non-UW IRB:

Used to make an update to the study after the reviewing IRB has issued approval

  • “Follow-on” submission from the study record
  • 2 types of modifications
    • Study Team Changes (to update study access)
    • Other Changes (to change UW PI)
 MOD
Study Update Used to update the study details for studies reviewed by an external IRB UPDAT
Continuing Review For studies reviewed by the UW IRB, used to submit a request for continued study approval or to close the study

  • “Follow-on” submission from an initial application
  • Can be combined with a modification
 CR
Combined Modification and Continuing Review Used to make a modification to the study at the time of continuing review MODCR
Reportable New Information Used to submit any issues or relevant new information

  • May be associated with a study, a site, a modification, or active research in general
 RNI

Submission States

The submission state indicates where the submission is in the IRB process workflow.

In-Review States

State Description
Pre-Submission The submission has been created but has not yet submitted to HSD for review. Applications must be submitted by the PI or PI proxy.
Discarded The application was discarded before the completion of review by HSD.
Administratively Withdrawn HSD staff have withdrawn the application from review after it was submitted to HSD.
Pre-Review The application has been submitted to HSD for review and is currently in the queue for review or being reviewed by HSD staff.
Clarification Requested (Pre-Review) HSD staff have requested more information about this application as a part of the review.
Pre-Review Completed Initial determinations have been made but the application has not yet been assigned to an expedited reviewer or to an IRB meeting for additional review.
Non-Committee Review The application has been assigned to a designated reviewer to complete the review.
Committee Review The application has been assigned for review by a full committee.
Clarification Requested (Designated Review) The designated reviewer has requested additional information from the study team in order to complete review of the application.
Clarification Requested (Committee Review) An IRB member has requested additional information from the study team before the application is reviewed at a convened IRB meeting.
Deferred The IRB committee has deferred the application, or determined at a convened meeting that additional information is needed in order to make a determination. The study team must submit a response to the committee.
Post-Review The review has been completed and the application is in the queue for IRB staff to complete processing of the submission.
Modifications Required The designated reviewer or IRB committee has determined that changes are needed in order for an application to be approved.
Modifications Submitted The study team has submitted the required changes for approval and the application is in HSD staff’s queue for review.

Review Complete States

State Description
Approved The application received full IRB approval or was determined to be exempt from the regulations. See the letter available in the study workspace for more information.
Human Research, Not Engaged HSD has determined that the UW is not engaged in the research.
Not Research HSD has determined that the study is not research as defined by federal regulations.
Not Human Research HSD has either determined that the study is not research as defined by federal regulations or that the study is not considered research with human subjects. The type of Not Human Research determination is listed in the study workspace and in the determination letter.
Disapproved The IRB committee disapproved the application.
Closed A previously approved study has been closed.
Lapsed IRB approval has expired for the study. The study team must submit a request to renew or close the study.
Suspended A previously approved study or site has been suspended.
Terminated A previously approved study or site has been terminated.

External IRB Specific States

State Description
Pending sIRB Review The study is being reviewed by an external (non-UW) IRB. The reviewing IRB’s decision has not yet been recorded by HSD.
External IRB An external (non-UW) IRB is acting as the IRB of record.
Active The multi-site or collaborative external (non-UW) IRB study has been approved by the reviewing IRB, and HSD has received documentation of the reviewing IRB’s approval.

Site Specific States

State Description
Invitation Pending UW has not yet confirmed whether or not the non-UW site may receive IRB review from UW.
Awaiting Site Materials HSD has not yet received confirmation that all of the site materials are accurate and available in the site application.
Inactive The site has been inactivated and never received or is no longer receiving review from the UW IRB.
Active The non-UW site’s involvement in the UW study has been approved.

RNI Specific States

State Description
Acknowledged The RNI is not considered a serious issue and the review is complete.
Action Required The RNI has been reviewed by the IRB and additional action has been required.
Action Submitted The required action has been submitted for the RNI and is in the queue for HSD’s review.
Complete The review of the RNI has been completed.