DIN/UPI __________
Enter the DIN/UPI number associated with the participant.
Infusion date ____________
Recipient weight at infusion _______ kg
Enter the participants weight at infusion in the “NNN.NN” format. This format allows for 3 digits before the decimal and up to 2 digits after.
Post-thaw processing: Cellular products distributed for infusion
Viable CD34+ Enriched cells __________ x 10 6 / kg
Enter the amount of CD34+ Enriched cells that are in the cellular product after the thaw process. Enter the amount in the “NNNNNNNNNN” format. This allows for 10 digits without a decimal.
Viable CD34+ T Cell Addback cells __________ x 10 6 / kg
Enter the amount of CD34+ T cells that were added back into the cellular product after the thaw process. Enter the amount in the “NNNNNNNNNN” format. This allows for 10 digits without a decimal.
Viable CD34+ cells Total __________ x 10 6 / kg
Enter the total amount of CD34+ cells that are in the cellular product after the thaw process. This includes the T cells that were added back. Enter the amount in the “NNNNNNNNNN” format. This allows for 10 digits without a decimal.
Viable CD3+ Enriched cells __________ x 10 6 / kg
Enter the amount of CD3+ Enriched cells that are in the cellular product after the thaw process. Enter the amount in the “NNNNNNNNNN” format. This allows for 10 digits without a decimal.
Viable CD3+ T Cell Addback cells __________ x 10 6 / kg
Enter the amount of CD3+ T cells that were added back into the cellular product after the thaw process. Enter the amount in the “NNNNNNNNNN” format. This allows for 10 digits without a decimal.
Viable CD3+ cells Total __________ x 10 6 / kg
Enter the total amount of CD3+ cells that are in the cellular product after the thaw process. This includes the T cells that were added back. Enter the amount in the “NNNNNNNNNN” format. This allows for 10 digits without a decimal.
CD34 Enriched Cells volume distributed _______ mL
Enter the total volume of CD34 enriched cells that was distributed to the clinical site. Enter the amount in the “NNNNN” format. This allows for 5 digits without a decimal.
T Cell Addback Cells volume distributed _______ mL
Enter the total volume of T cells that were added back. Enter the amount in the “NNNNN” format. This allows for 5 digits without a decimal.
Total volume distributed _______ mL
Enter the total volume of the product that was distributed to the clinical site. Enter the amount in the “NNNNN” format. This allows for 5 digits without a decimal.
CD34 Enriched Cells Expiration time (24-hour format) __ __ : __ __
Enter the CD34 enriched cell expiration time. Enter the time in the 24-hour format.
T Cell Addback Expiration time (24-hour format) __ __ : __ __
Enter the T Cell Addback expiration time. Enter the time in the 24-hour format.
Cellular product infusion summary
Enter the CD34 infusion start and completion time (24-hour format)
Was CD34 Enriched product fully infused?
Indicate if the CD34 enriched product was fully infused. If “No” is selected, enter the number CD34+ and CD3+ cells infused in the “NNNNNNNNNN” format. This format allows for ten digits before the decimal and zero digits after the decimal.
Enter the T Cell Addback infusion start and completion time (24-hour format)
Was T Cell Addback cells product fully infused?
Indicate if the T Cell Addback product was fully infused. If “No” is selected, enter the number CD34+ and CD3+ cells infused in the “NNNNNNNNNN” format. This format allows for ten digits before the decimal and zero digits after the decimal.
Were any adverse events reported during product infusions or post-infusion observation? If Yes, complete and submit an Adverse Event report regarding the infusion of the cellular products and submit within 24 hours of the event.
CCG v.1 | CRF v.1
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