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 appropriate HCT infusion form (Form 2006).
Form 4003 is designed to capture product specific information for all products/infusions 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, each product type must be analyzed and reported on a separate Form 4003. A product from the same donor undergoing different manufacturing steps or manipulations are considered different products and require multiple 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 Form 4003.
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.
|1/24/2020||4003: Cellular Therapy Product||Modify||Version 3 of the 4003: Cellular Therapy Product section of the Forms Instruction Manual released. Version 3 corresponds to revision 3 of the Form 4003.|
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