Kit Chain of Custody (Blinded) report

In this report, you receive a blinded view of all kits in a study. When run at the site level, the report describes every transition a kit has made throughout the study, both virtual and physical. The report also includes details on changes made to each kit.

Information on the changes of kits include:

• Creation of the kit
• Assignment to a lot
• Assignment to a depot
• Shipped to a site
• Dispensation to a subject
• Destruction of the kit

Modes

Available in 3 modes: Testing, Training, and Production.

Permission required to run the report

Any user who's assigned the Run the Blinded Chain of Custody Report permission can generate this report.

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.

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	(Available if Yes for Include Audit Trail is selected) Choose a date range for the report. The report will include only kits with status changes during the date range.
Kit Status	Select a kit's status for each event. For example, a kit may start as New and progress to Available (at the depot), In Transit, Available (at the site), and Dispensed
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, PDF or HTML.

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
Site Name	A site's name as entered by the site manager when they created the site
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
Subject ID	A subject's distinct ID code
Date Range	Period of time you selected when running this report
State	The state of the kit(s) you selected when running this report
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

Fields in Kit section	Description
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)
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.
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
Study Org ID	ID of the site or depot
Study Org Name	Long name of the site or depot
User Name	The user responsible for the transaction
Return Study Org 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 Study Org 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
Expiration Date	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.