Protocol Builder Interface
This workflow checks the PB study_info("documents") endpoint to see if Package Inserts and/or Investigator Brochure is a required document, i.e., found on the study cover sheet.
CRC1 Stats
This workflow does not have any CRC1 stats.
Study Dashboard Menu Dependencies
| State | Condition |
|---|---|
| required | Package Inserts and/or Investigator Brochure are required |
| optional | Package Inserts and Investigator Brochure are not required |
Workflow Description
This workflow allows the Coordinator to upload Package Inserts documents and/or Investigator Brochure documents, if either or both are required, and As Applicable Drug/Device Documents.
The workflow begins with the Load Data Script Task which starts by retrieving documents from the study_info API. Next it checks to see if UVA is the IRB of record by determining if the Non UVA IRB - Initial and Last Continuation document is required or not. The Package Inserts and Investigator Brochure documents are next checked to see if either or both of them are required and the boolean variables isPackageInsert and isInvestBrochure, respectively, are set accordingly. The script next cycles through the previously retrieved documents for any that have been designated in irb_documents.xlsx to be part of the Drug Device Documents workflow. Several actions are done for each document tagged with that workflow, which are:
- Build a label for each document type with includes a lock icon at the beginning based on the data configuration for that document in irb_documents.xlsx.
- Set a data variable for each document as True if it is locked on IRB PreReview submission, False if not.
- Set a data variable for each document as True if it will included in the zip file of documents sent to the IRB for PreReview submission, False if not.
- For As Applicable documents only, the drug_dev enum data dictionary that is used to populate a dropdown of document types later is built.
The script ends with checking to see if either of the required documents were previously uploaded and a refresh of PB data indicates they are no longer required. If so, all previously updated documents no longer required are deleted.
The workflow next proceeds to a Parallel Gateway, which allows the user to pick any of the available document options. An Exclusive Gateway is in the paths for Package Inserts and Investigator Brochures, each of which checks the respective variables isPackageInsert or isInvestBrochure to see if the document is required. Each required document will be available in the workflow navigation menu and documents not required will not.
Both of the User Tasks for uploading Package Inserts or Investigator Brochures are configured with the document code in the Form Field ID. Both also allow multiple documents to be uploaded, so a repeating section configuration is used to include the Form Field ID with the document code and the associated configurable metadata fields, ShortDesc, VerDate and Lang. The Investigator Brochure also has a unique metadata field, Name, included in its repeating section.
The As Applicable User Task is configured to allow the user to add one or more documents in the remaining Drug/Device categories. The drug_dev enum data dictionary described above in the Load Data section is used to populate the dropdown of the AsApplDrugDeviceDocType Form Field, which allows the Coordinator to select which category of As Applicable documents to upload. The AsApplDrugDeviceDoc Form Field uses the doc_code Property ID to set the category with the AsApplDrugDeviceDocType.value as its Value. The As Applicable workflow allows multiple documents to be uploaded for each selected category, so a repeating section configuration is used to include the Form Field IDs AsApplDrugDeviceDocType, AsApplDrugDeviceDoc and the associated configurable metadata fields, ShortDesc, VerDate and Lang.
After all active document upload User Tasks have been saved, the workflow executes the Load Summary Data Script Task which reloads the study_info("documents") info for all Drug/Device documents, as to reflect updates that occurred during the previous User Tasks. This data is used to display the End Event Summary specified in its Element Documentation, which shows a summary of all categories with uploaded documents and a list of those categories which had none.
Generated Documents
No documents are generated from this workflow.