Pregnancy Test

*The timeline requirements for this form are as follows:
Assessment Time Frame: Within 45 days prior to the anticipated start of the conditioning regimen.
Submission Time Frame: Within 5 business days of collection.

*This form will only appear in the EDC if the “Sex Assigned at Birth” field on Demographics form is answered Female.

Was a pregnancy test performed:
Indicate if a serum or urine pregnancy test was performed. Per protocol test is required for women of childbearing potential. If field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.

If field is answered Yes complete the Date of sample collection for pregnancy test, Specimen Type, and Pregnancy test result fields below.

If field is answered No complete the “Reason pregnancy test not performed” field below.

Reason pregnancy test not performed:
Indicate reason pregnancy test was not performed:

• Subject is female of non-child bearing potential (i.e., subject had surgical sterilization or is post-menopausal)
• Other
  

Specify:
If Reason pregnancy test not performed is answered “Other”, describe the other method in the free textbox (up to 200 characters).

Date of sample collection for pregnancy test:
Report date of sample collection for pregnancy test. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.

If the date entered is a future date, a query will appear in the EDC.

Specimen Type:
Report the specimen type of pregnancy test as “Serum” or “Urine”.

Pregnancy test result:
Report the subject’s pregnancy test result as either “Positive” or Negative”.

If field is answered Positive, a query will appear in the EDC.

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