Business Requirements
-
Each study will have only one final protocol uploaded
- When sent to the IRB, it will be placed in the Study<>Protocol<>Document IRB Online bucket.
- Subsequent uploads will replace the previous copy-
-
If UVA is the IRB of record, as indicated by the absence of the Non UVA IRB Approval - Initial and Last Continuation document on the PB Cover Sheet......
- Each study will have only one final UVA IRB of record Coversheet uploaded
- When sent to the IRB, it will be placed in the Study<>Coversheet IRB Online bucket
- Subsequent uploads will replace the previous copy.
- Each study will have only one final UVA IRB of record Application uploaded
- The Application Type should be selected from the following list:
- Protocol Information Form for HUD
- Request for Medical Records
- Determination for Non-Human Subject Research
- Determination for Non-UVA Agent
- Exempt Application
- Non-engaged Application
- Expedited Application
- Full Board Application
- When sent to the IRB, it will be placed in the Study<>Application<>Document IRB Online bucket
- Subsequent uploads will replace the previous copy.
- The Application Type should be selected from the following list:
- Each study will have only one final UVA IRB of record Coversheet uploaded
-
If UVA is not the IRB of record, as indicated by the presence of the Non UVA IRB Approval - Initial and Last Continuation document on the PB Cover Sheet...
- Each study will have only one final UVA IRB of record Coversheet uploaded
- When sent to the IRB, it will be placed in the Non-UVAIRB<>Study Protocol Coversheet IRB Online bucket
- Subsequent uploads will replace the previous copy.
- Each study will have only one final UVA IRB of record Application uploaded
- The Application Type should be set to: Non-UVA IRB Application
- When sent to the IRB, it will be placed in the Non-UVAIRB<>Application IRB Online bucket
- Subsequent uploads will replace the previous copy.
- Each study will have only one final UVA IRB of record Coversheet uploaded
Protocol Builder Interface
This workflow rely on PB coversheet displaying or not displaying the following documents:
- Non UVA IRB Approval - Initial and Last Continuation
- If on the PB Coversheet, indicates that UVA-HSR is not the IRB of record
- If not on the PB Coversheet, indicates that UVA-HSR is the IRB of record
CRC1 Stats
This workflow does not have any CRC1 stats.
Study Dashboard Menu Dependencies
| State | Condition |
|---|---|
| required | Always |
Workflow Description
The workflow starts by executing the Load Data Script Task which executes the study_info('documents') IRB API call to determine the state of PB Coversheet documents. If Non UVA IRB Approval - Initial and Last Continuation is not required, the variable isUVA_IRBofRec is set as True. If the document is required, isUVA_IRBofRec is set as False. The status of the IRB Reliance Agreement Request Form- IRB-HSR Not IRB of Record document is checked and if required, isRelianceAgreement is set as True and if not required, it is set as False. The status of the IRB Approval or Letter of Approval from Administration: Study Conducted at non- UVA Facilities document is checked and if required, isNonUVA_Facilities is set as True and if not required, it is set as False.
The Upload Protocol User Task is next executed which allows the Coordinator to upload a single Protocol document file which is placed in the Study<>Protocol<>Document IRB Online bucket. The Coordinator is also prompted to enter the Protocol version date and owner ID. When saved, the Protocol document appears in the Document Pane under the Study section.
The Store Protocol MetaData script task then stores Protocol file metadata version data and owner ID in the file datastore for future reference.
The workflow next uses isUVA_IRBofRec to determine which flow to follow coming out of the Is UVA IRB of record? Exclusive Gateway. If isUVA_IRBofRec is True, the workflow continues on the lower, default flow to a Parallel Gateway encasing the Upload UVA Coversheet User Task and Upload UVA Application User Task. The Upload UVA Application User Task will allow the Coordinator to select the appropriate Application type which are loaded from the IRB_HSR_Application_type.xls spreadsheet. The Upload UVA Coversheet User Task allows the Coordinator to upload the Coversheet document to the Study<>Coversheet IRB Online bucket or the Application document to the Study<>Application<>Document IRB Online bucket. As each of these tasks are saved, the document appears in the Document Pane under the Study section and the workflow ends.
The Store UVA Application MetaData script task then stores the Application file metadata for application type in the file datastore for future reference.
If isUVA_IRBofRec is False, the workflow continues to the upper flow to a Parallel Gateway encasing encasing the Upload non-UVA Coversheet User Task, Upload non-UVA Application User Task and Upload non-UVA Approval User Task. The Upload non-UVA Application User Task sets the Application Task to: Non-UVA IRB Application. The Upload non-UVA Coversheet User Task allow the Coordinator to upload the Coversheet document to the Non-UVA IRB<>Study Protocol Coversheet IRB Online bucket or the Application document to the Non-UVA IRB<>Application IRB Online bucket or the Approval document to the Non-UVA IRB<>Approval New Protocol Non-UVA IRB IRB Online bucket. As each of these tasks are saved, the documents appear in the Document Pane under the Non-UVA IRB section and the workflow ends.
The Store Non UVA Application MetaData script task then stores the Application file metadata for application type in the file datastore for future reference.
The File Datastores mentioned above documented here.
Generated Documents
No documents are generated in this workflow.