ISBT 128 Clinical Trials Product Description Codes were specifically developed for the identification and labeling of clinical trials products. These Clinical Trials PDCs are standardized global identifiers allocated by ICCBBA, which may be used by organizations licensed with ICCBBA, including clinical trials facilities, clinical trial sponsors, and cell and gene therapy manufacturers.
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This video outlines the benefits and labeling standards for Clinical Trials Product Description Codes using ISBT 128, the international consensus-driven information standard used for labeling Medical Products of Human Origin.
The information provided in this video is presented by ICCBBA, an international non-profit organization that manages and develops the ISBT 128 Standard.
Facilities implementing ISBT 128 can label their Clinical Trials Medical Products of Human Origin using local codes. However, since local codes are not globally unique, this approach may result in facilities receiving different Clinical Trial MPHOs labeled with identical local codes from multiple sources.
ICCBBA manages and issues ISBT 128 Clinical Trials Product Description Codes to ensure uniqueness and support product identification and traceability.
Facilities already using ISBT 128 can encode Clinical Trials PDCs into their established software system allowing for easier implementation of the new codes.
Facilities define allocated sets of Clinical Trials PDCs using their proprietary terminology and are responsible for the eye-readable label text that corresponds with their assigned PDCs. Once defined, a Clinical Trials Product Description Code shall not be redefined.
Clinical Trials Product Description Codes act as one of the essential elements necessary for bidirectional traceability of a product throughout the lifecycle of the manufacturing process to the point of administration – serving the same function as traditional ISBT 128 Product Description Codes.
Clinical Trials Product Description Codes are assigned to facilities by ICCBBA. These 5-character codes are assigned in sequential order beginning with uppercase Y, followed by an uppercase alpha character in the second position, with numeric characters in positions 3-5.
Labels applied to Clinical Trials Products intended for Further Manufacturing follow the same format as standardized products collected for further manufacturing.
This label format consists of:
- The Donation Identification Number
- The Product Code
- The Division Identifier
- The ISBT 128 Chain of Identity Identifier
- The intended use of the product
- Information pertaining to the product donor
- Intended recipient information
- Product expiration dates and times
- Sponsor or Manufacturer Protocol Identifier, and
- Sponsor or Manufacturer Identification
Facilities can reserve Clinical Trials Product Description Codes by navigating to the “Technical Library” section of the isbt128.org site and selecting "*Request a PDC". Once on this page, follow the steps outlined in the “Requests For Clinical Trials PDCs” Section and submit the subsequent “Request Form for Clinical Trials PDCs”.
Following submission of the Request Form and invoices, globally unique Clinical Trial PDCs will be issued within 5 business days. Once issued by ICCBBA, Facilities are free to define and utilize their respective codes.
If you wish to know more about the ISBT 128 Standard, visit our website at www.isbt128.org or contact us at support@isbt128.org. Special thanks to Mr. Josh Geary of the Dana-Farber Cancer Institute for his contributions to ICCBBA for this video.