Submission Types and States
Table of Contents
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:
|
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
Studies Reviewed by a Non-UW IRB: Used to make an update to the study after the reviewing IRB has issued approval
|
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
|
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
|
RNI |
Submission States
The submission state indicates where the submission is in the IRB process workflow.
- In-Review States
- Review Complete States
- External IRB Specific States
- Site Specific States
- RNI Specific States
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Administratively Withdrawn | HSD staff have withdrawn the application from review after it was submitted to HSD.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. |