Question 69: Date of manipulated product infusion

Report the date this product was infused. If the product was infused over multiple days, report the first date of infusion.

Questions 70 – 71: Specify the route of product infusion

Report the route by which the product was infused.

  • Intravenous: refers to the infusion into the veins. Examples include infusion via central line or via catheter.
  • Other route of infusion: If the product was infused other than intravenously, select this option and specify in question 71. This option should be used sparingly since the only known method of infusion for gene therapy products is intravenously.

Question 72: Was the unmanipulated (“back up”) product infused?

Indicate Yes or No if the unmanipulated product was infused. If No, continue with the Signature Lines.

This question is only enabled if it is reported a Portion of product was manipulated.

*Question 73: Date of unmanipulated product infusion

Report the date the unmanipulated product was infused. If the product was infused over multiple days, report the first date of infusion.

*Questions74 – 75: Specify the route of unmanipulated product infusion

Report the route by which the product was infused.

  • Intravenous: refers to the infusion into the veins. Examples include infusion via central line or via catheter.
  • Other route of infusion: If the product was infused other than intravenously, select this option and specify in question 75. This option should be used sparingly since the only known method of infusion for gene therapy products is intravenously.

*Signature Lines:

The FormsNet3SM application will automatically populate the signature data fields, including name and email address of person completing the form and date upon submission of the form.

Last modified: Nov 01, 2021

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