sartography
/
cr-connect-configuration
mirror of https://github.com/sartography/cr-connect-configuration.git
1
0
Fork 0
Code Issues Packages Projects Releases Wiki Activity

Updated IDE (markdown)

calexh-sar 2021-04-20 15:55:34 -04:00
parent 1f0b189e26
commit 4ff3c206ae
1 changed files with 31 additions and 4 deletions
Show Stats Download Patch File Download Diff File Expand all files Collapse all files

35
IDE.md

@ -6,12 +6,39 @@ This workflow does not have any CRC1 stats.
### Study Dashboard Menu Dependencies
| State | Condition |
|----------|-----------|
| required | |
| disabled | |
| hidden | |
|:--------:|-----------|
| 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_IND?**_ exclusive gateway checks to see if the IS_IND 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 _**Confirm IND Status**_ user task allows the coordinator to confirm or change the interpretation of the information pulled from PB and add additional information about each drug, which includes the holder type and drug/biologic name. If the _**IND Number Check**_ determines that the study might be exempt, a question to confirm or refute the assumption is provided. Another confirmation for each IND in this task if 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.
![Confirm Section](https://images.zenhubusercontent.com/5f0623d8a1d620a9f39301dc/594e5a1a-e58c-4015-b2a2-7f227c4a6474)
If the study is not exempt and a holder name is needed, there is a section for each IND to determine how that name will be provided:
- Selected from the list of sponsors pulled rom PB
- Option provided if the Coordinator indicated in the _**Confirm IND Status**_ 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
No documents are produced from this workflow.