Question 2-3: Date of cell product collection

Report if the date of cell product collection is “known” or “unknown” for question 2. If the date of cell product collection is known, report the date (YYYY-MM-DD) in question 3. If the date of cell product collection is unknown, continue with question 4.

If the exact date is not known, refer to General Instructions, General Guidelines for Completing Forms for more information regarding reporting partial or unknown dates.

Question 4-5: What is the tissue source of the cellular product? (check all that apply)

Select from the list the tissue source(s) of the cellular product being reported in this instance. If the source is selected as ‘Other tissue source’, specify the other source in question 5 and continue with question 6.

Question 6-7: What is the cell type? (check all that apply)

Select from the list the cell type(s) of the cellular product being reported in this instance. This should be the type of cell(s) harvested to make the product and / or in the product infused. If the cell type is selected as ‘Other cell type’, specify the other cell type in question 7 and continue with question 8. All cell types selected here must also be reported on the Cellular Therapy Infusion Form 4006. Please refer to the 4006 Manual, Q18-46 for description of cell types.

If “cytotoxic T lymphocytes (CTLs)” is selected, a Form 2005 Confirmation of HLA Typing form will also need to be completed.

Question 8-11: Where was the cellular therapy product manufactured / processed?

If the product was manufactured by a pharmaceutical or biotech company, continue with question 10 and select pharmaceutical or biotech company from the list. If the company is not in the dropdown list, select other pharmaceutical company and report the name and location of the company in question 11. Continue with question 12.

If the product was manufactured by a cell processing laboratory off site that is not a pharmaceutical / biotech company, continue with question 11 and report the name and location of the laboratory. Continue with question 12.

If the product was manufactured by a cell processing laboratory at the same center as the product is being infused, continue with question 12.

If the product was manufactured by another site not listed above, continue with question 9 to specify the other site and report the name and location in question 11. Continue with question 12.

Last modified: Jan 27, 2020

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