Below is an example specification for a lab label template design. This is a useful concept for sites to maintain internally amongst users who will be overseeing and maintaining label designs. In this example, changes can be tracked using ticket numbers in the notes. The screenshot images are included to show that annotated screenshots provide useful and specific information more than just text descriptions.
The intention is for this to serve as a set of suggestions, not intended for copy. Customers are encourages to make their own specifications, descriptions, screenshots, and notes to meet label specification requirements.
Lab Labels
Lab Labels must contain the following:
Barcode w/ number
Study Name/Number
Period & Trial Day
Timepoint
Randomization Number
Volunteer ID
Nature of sample
Lab Destination
Container Type
Sample Path / Lab Panel
Parent Barcode
Label Text | ClinSpark Data | Screenshot | Definition | Conditions/Logic | Notes |
|---|---|---|---|---|---|
Volunteer ID | Volunteer ID |  | Volunteer ID associated with the subject. | ||
Timepoint | Timepoint |  | Timepoint associated with a timed activity. | If there is no associated timepoint with barcode, label will display: Timepoint NA |
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Study Name/Number | Study Name |  | |||
Sample Path or Lab Panel | Sample Path or Lab Panel associated with Item |   | This is the lab panel or sample path associated with the item. This is useful to display on the label, since the name of the sample path or the lab panel will be a meaningful reference for the study floor staff and lab technicians. | ||
Randomization Number | Randomization Number Lead In Number Screening Number |  | Subject study identifier. Subjects may only have some of these values assigned. | On the label, the first in the below list which is present on the subject will appear in the label. Randomization Number (shown as “Rand#") Lead In Number | shown as “L-I#” Screening Number | shown as “Scr#” If none of the above are associated, label will display: L-I/Scr/Rand# NA |
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Period & Trial Day | Study Event Name |  |
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Parent Barcode | Parent Barcode of the sample transfer |  | When printing a sample transfer this field will be populated to contain the parent barcode of the sample transfer. In the scenario of aliquot of an aliquot the the most immediate parent barcode would be referenced. |
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Nature of sample | Item Alias ‘natureOfSample’ or Item Label Field 1 | If using Item Alias, it must must match: natureOfSample 
 | This represents the intended purpose (nature of) the sample contained inside of the specimen container. Examples of nature of sample values: Safety; PK; PD; Genomics Note that Item Label Field 2 does not appear, it is not used for this label at all. | To allow flexibility amongst study designers and lab managers, nature of sample is defined through using either an item alias or the use of Item ‘label field’ metadata. The label logic will first look for a matching item alias. If there is no matching item alias, it will display the defined value in Item Label Field 1. If there are no values defined for either, it will appear blank on the label. | |
Lab Destination | Lab Name on Associated Lab Panel, or Sample Transfer Barcode Notes | If there is a lab service code attached, this is the name of the lab interface to which the same will be sent. If there is a sample processing panel attached to the item, this should be the barcode notes in the sample processing path.  If the sample is split or transferred, this will be the barcode notes associated with the transfer material.  | This represents where the sample is intended to be sent for analysis. | If there is a lab service code attached, this is the name of the lab interface to which the same will be sent. If there is a sample processing panel attached to the item, this should be the barcode notes in the sample processing path. If the sample is split or transferred, this will be the barcode notes associated with the transfer material. | |
Container Type | Item Specimen Container | Study Lab Panels 
 Samples  If there is no transfer, then the Specimen Container will display in this field.  These labels show how these two variations look when printed:  | This is the description of the container that contains the specimen. Specimen containers are configured as part of system setup. However the labels will display on the barcode the description associated with the container tied to the Sample Path, Study Lab Panel, or Sample Transfer Step. | Study Lab Panels For Items with a Study Lab Panel associated, the value displayed will be the Container description on the Study Lab Panel Samples This field populates differently for items which have Sample Paths. To see where the item will get the value for this label field, navigate to the Sample Path referenced in the item. If there is no transfer, then the Specimen Container will display in this field. If there is a transfer, then the material column value will display. |
Barcode Properties
The label barcodes are 1 dimensional data representation. The length of the barcode appearing on the label is a function of the amount of data.
Role Based Dependencies
Due to the reliance on Item Aliases and Sample Transfer Barcode Notes, changes to this label may require a collaboration between lab managers, study designers, and data managers. Each of these groups have an independent reliance on aliases, so it’s important use clear and different terminology when assigning aliases to items.
Users with role action CRF Design Study Library will be able to change Item aliases.
Users with role action Samples Configure will be able to update Sample Transfer Barcode Notes.