Kit Chain of Custody (Unblinded) report
In this report, you get an unblinded view of all the kits in a study. The report shows every transition that a kit has made throughout the study, both physical and virtual, plus the user who made the change, when the change happened, and any comments they provided.
- Creation of the kit
- Assignment to a lot
- Assignment to a depot
- Shipped to a site
- Dispensation to a subject
- Destruction of the kit
This report is useful for a clinical supply manager or other unblinded user. We recommend running this report as a CSV file so that you can filter and sort the data to find what you need. You might run this report during the study conduct period so you can see the kits in a given lot or at the depot. You might run the report at the end of the study if you need to get various views into some or all kits in the study.
Users with Blinded Depot User permission can now see unblinding kit numbers to fulfill shipments. Only data from manually associated depots and sites by the user administrator will show when running the report.
Keep in mind that if you need information about one or two kits, you can open the Kit Reconciliation tab and get your answer quickly and easily. This report is more useful when you need to view data related to a number of kits.
Modes
Available in all 3 modes: Testing, Training, and Production
Permission required to run the report
Any user who's assigned the Run the Unblinded Chain of Custody Report permission can generate this report.
Filters
| Filter | Description |
|---|---|
| Include Audit Trail | Choose Yes to see the current kit status plus all historical changes to them; choose No to see only the current Kit status. |
| Transaction Date | Choose a date range for the report. The report will include only kits with status changes during the date range. |
| Kit Type ID | Choose one or more kit types to include in the report, or leave this filter blank to run the report for all kit types. |
| Shipment ID | An unique identifier for the shipment |
| Quarantine ID | The tracking number for a kit or shipment that has experienced a temperature excursion. |
| Location | Choose one or more sites or depots to include only the kits at the location in the report, or leave this filter blank to include kit types at all locations. |
| Subject Number | Choose one or more subjects to include only the kits dispensed to them, or leave this filter blank to include kits dispensed to all subjects. |
| File Type | Choose the output type for the report: CSV, HTML, or PDF.
Note: We recommend choosing CSV, so that you can narrow your view of the data. You can then sort by Sequence Number and Transaction Date to see the complete lifecycle. |
Field descriptions
Note:
Fields that don't have any corresponding values are marked as N/A in the report.
| Initial Fields | Description |
|---|---|
| Customer Name | A customer's name used to purchase the cloud subscription |
| Study Name | A study's ID as entered by the study manager when they created the study |
| Mode | The mode in which you ran this report. For example, you may run a report in Testing mode to verify the data of your sites before going live with your study |
| Include Audit Trail | Setting that indicates if you included audit trails in your report or not |
| Kit Type ID | The Kit Type ID you selected to be included in the report |
| Subject Number | The Subject Number(s) you selected to be included in the report |
| Transaction Date | Period of time you selected when running this report to view data in your study |
| Report Generated By | User name of the user who ran this report (typically a training manager) |
| Created Date | UTC time and date of the current generated report |
| Location | The location you selected for audit history, either a site or depot |
| Fields in Kit section | Description |
|---|---|
| Kit List | The name of the kit list as entered by the clinical supply manager |
| Kit Type ID | Unique code entered in the design of the study for a kit |
| Kit Description | A kit's description is also a unique value, this description is either visible (unblinded distribution) or hidden from site users based on the study design |
| Kit Number | A unique number assigned to individual kits (serialized kit distribution) |
| Sequence Number | This number is potentially unblinding. The distribution vendor uses it for filling shipment requests |
| Barcode | The barcode of the kit as it was either generated by the system |
| Device ID | ID of the device |
| Transaction Date | The UTC time and date of the kit transition |
| Dispensation Confirmation | Setting that indicates if the dispensation was confirmed or not |
| CRA Verified | This field indicates if the CRA verified the kit or not |
| Status | A kit's status for each event, for example, a kit may start as new and progress to Available (at depot), In Transit, Available (at site), Dispensed, and Misallocated. |
| Dispensing Visit | Indicates as part of which visit a kit was dispensed. |
| Instance Number | Reflects visit cycle instances whenever cycling is enabled for the study. |
| Reason for Change | Where applicable, user indicates a reason for change when updating a kit's status. Not all state changes require this additional comment" |
| Units per Kit | Number of individual consumable units in a kit such as a pill count or mg |
| Returned Units | Number remaining in the kit as indicated by the site user or clinical research associate (CRA) in the kit reconciliation process |
| Missing Units | Number of units that are missing from the kit as indicated by the site user or clinical research associate (CRA) in the kit reconciliation process |
| Balance Units | Number of units in the kit that is assumed were consumed by the subject |
| Units Returned to Depot | Number of units in a kit returned to depot |
| User Name | The user responsible for the transaction |
| Study Organization ID | ID of the site or depot |
| Study Organization Name | Long name of the site or depot |
| Return Organization ID | Indicates the ID of the site or depot a kit has been returned to. This field appears only when a kit is returned for a kit reconciliation shipment |
| Return Organization Name | The full name of the site or depot a kit has been returned to. This field appears only when a kit is returned for a kit reconciliation shipment |
| Subject Number | If dispensed, the subject number is included in the report |
| Manufacturing Lot | Minimal requirement for lot assignment, this lot group provides expiration, Do not count, and Do not ship dates for the inventory management system |
| Label Group | The name of the Label Group the kit is assigned to |
| Expiration | Expiration date assigned to the kit |
| Shipment ID | If the kit was selected for a shipment, this is a unique identifier. If a shipment from depot to site, or from site to destruction depot, is canceled, the Shipment ID will still be present. However, if a kit is removed from a shipment from depot to site, the Shipment ID will not be present on the report |
| Quarantine ID | A tracking number assigned to a kit or shipment that has experienced a temperature excursion. |
Parent topic: Report descriptions