Protocol Builder Interface
If Coordinators specify in PB an Investigational Device is used in the study, the IRB API Details variable IS_IDE is set to 1 (true). If true, PB provides fields to enter the IDE #, if available, which is stored in the IRB API Details variable IDE. The Coordinator is also asked if the device was developed at UVA, and if so, the IRB API Details variable IS_UVA_IDE is set to 1 (true).
CRC1 Stats
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Study Dashboard Menu Dependencies
| State | Condition |
|---|---|
| Required | IRB API Details variable IS_IDE is 1 |
| Hidden | IRB API Details variable IS_IDE is 0 or Null |
Workflow Description
In the Load IDE Data script task the variables IS_IDE, IDE and IS_UVA_IDE are pulled from the IRB API Details endpoint. The list of PB Sponsors is configured into enum dropdown format to be used for indicating the IDE Holder. Additionally, the enum list for Holder Type is configured into enum dropdown format using the the following logic:
- Included if no IDE number is provided
- IDE Exempt
- IDE not exempt, but no IDE#
- Included if IS_UVA_IDE is 1
- UVA PI
- UVA Center
- Included if IS_UVA_IDE is 0 or Null
- UVA Center
- Industry
- Other Colleges and Universities
- Other PI
These variable are then passed through two decision tables, IND Number Check and UVA IND Check. The IND Number Check decision table determines if there were any IND numbers entered in PB and if not, the study is defaulted to be Exempt. For each IND_n variable the default for the Holder Type dropdown is set to "" if there is a number and NA if there is no number entered. The UVA IND Check decision table converts the PB results if 1 or 0 to True or False, respectively.
The IS_IDE? exclusive gateway checks to see if the IS_IDE variable from PB was converted to True and if so, continues with the workflow. If not, it takes the Coordinator to the Show Contact Support manual task which informs the Coordinator that they should not be in this workflow and instructs them to contact support. This should only occur if there is a failure of the menu logic.
The Enter IDE Info user task displays the IDE number, if available, and a message if it is not in read-only format. It also allows the coordinator to add the holder type and device name name. If a Holder Name is require, the Coordinator is asked whether the holder was included as a sponsor in PB, which is used in the next sections to determine if a selection from the PB Sponsors, a selection from UVA LDAP or free text is how the holder name will be provided.
If a holder name is needed, the next section determines how that name will be provided and allows the Coordinator to provide it:
- Selected from the list of sponsors pulled rom PB
- Option provided if the Coordinator indicated in the Enter IDE Info user task that the holder was added as a PB Sponsor
- The option to enter as text is provided if the Coordinator was mistaken and the holder was not found in the PB Sponsor list
- Selected from UVA's LDAP registry if not entered as a PB Sponsor and holder type is UVA PI
- The option to enter as text is provided if the Coordinator was not found in the UVA LDAP search
- Entered as text if not entered as PB Sponsor and holder type not UVA PI
- Script tasks to configure the text entry user task, if needed, to mimic the enum format so the output is in a consistent format.
Documents
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