This form must be completed for all products for Gene Therapy recipients. All patients receiving a Gene Therapy product will be placed into the CRF track. For TED only reporting centers, Form 2003 will also need to be completed.
The Gene Therapy Product (2003) form is designed to capture product specific information for all infusions given to a recipient as a course of gene therapy. PBSC collected from a single mobilization event (a mobilization event is the planned administration of growth factors or systemic therapy designed to enhance stem cell collection), even when collected over several days, is considered one product.
Multiple products are collected when, for example, the donor requires another mobilization to collect a product at a later date. The collection from the second mobilization event is considered a different product and should be reported on an additional 2003 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 – 6: Product Identification
Q7 – 15 : Product Collection
Q16 – 32: Product Processing / Manipulation
Q33 – 71: Product Analysis
Q72 – 81: 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 reference the retired manual section on the Retired Forms Manuals of the CIBMTR Forms Instruction Manual is intended to be a resource for completing the Gene Therapy Product Form.
| Date | Manual Section | Add/Remove/Modify | Description |
|---|---|---|---|
| 7/26/2024 | 2003: Gene Therapy Product | Add | Version 2 of the 2003: Gene Therapy Product section of the Forms Instructions Manual released. Version 2 corresponds to revision 2 of the Form 2003. |
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