This form must be completed for all products for recipients of non-HCT cellular therapy (including post-HCT “DCI / DLI” infusions). For recipients of hematopoietic cellular transplants (HCT), complete the Hematopoietic Stem Cell Transplant (HCT) Infusion (2006) form.
The Cellular Therapy Product (4003) form is designed to capture product specific information for all products given to a recipient as part of a course of cellular therapy. A series of collections from the same donor that uses the same collection method, even if the collections are performed on different days, should be considered a single cellular therapy product if only one set of manufacturing steps are applied to the collected material.
If more than one type of cellular therapy product is infused as part of a single course of cellular therapy, each product type must be analyzed and reported on a separate Cellular Therapy Product (4003) form. A product from the same donor undergoing different manufacturing steps or manipulations are considered different products and require multiple Cellular Therapy Product (4003) forms if each product is infused separately.
However, if the cells underwent different manufacturing steps or manipulations and at the end of the manufacturing process were combined for a single infusion or administration, it will be considered a single product and it will require a single Cellular Therapy Product (4003) form.
For more information see Appendix D–How to Distinguish Infusion Types and Appendix E–Definition of a Product.
Links to sections of form:
Q1-2: Cellular Therapy Product Identification
Q3-12: Cell Product Source
Q13-15: Collection Procedure
Q16-37: Cell Product Manipulation
Q38-46: Cell Product Analysis
Q47: Product Infusion
Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals.
| Date | Manual Section | Add/Remove/Modify | Description |
|---|---|---|---|
| 4/11/2022 | 4003: Cellular Therapy Product | Add | Instruction added for the preferred timepoint of viability when the product was cryopreserved: If the product was cryopreserved, viability post-thaw should be reported. |
| 1/28/2022 | 4003: Cellular Therapy Product | Modify | Version 5 of the 4003: Cellular Therapy Product section of the Forms Instruction Manual released. Version 5 corresponds to revision 5 of the Form 4003. |
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