Visit
Indicate the phase of the study in which the product event occurred. If product event is not associated with a listed phase, select “Other” and specify.
- Product Transit
- Thaw
- Infusion
- Other, specify _______
Date product received _______
Enter the date product was received DD/MMM/YYYY.
Date product event discovered_______
Enter the date the event was discovered DD/MMM/YYYY.
Donation ID _______
Enter the donation ID associated with the product.
Product event description
Indicate the best description of the event from the list. If description is not listed, select “Other” and specify.
- Thaw Issue
- Packaging Issue
- Labeling Issue
- Accompanying documents issue
- Change in product appearance
- Unexpected quantity or volume
- Other, specify _______
Was product infused
Indicate if the product was infused into the recipient.
If yes, was there a serious adverse event caused by, or probably caused by, the product
Indicate if a serious adverse event occurred and was definitely or probably caused by the product.
Is this event reportable to the IRB
Indicate if the event is reportable to the IRB of record.
CCG v.1 | CRF v.1
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