Sample Collection Date and Lab Location

Collection Date Time:
Enter the date and time the lab sample was collected. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used. Time should be entered in the 24-hour clock format.

Per protocol creatine clearance (CrCl) is required within 45 days prior to the anticipated start of the conditioning regimen. If the assessment date entered is outside of those parameters a protocol deviation should be logged in the EDC.

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

Lab Location:
Select your site’s lab location from the dropdown list. If there are not any lab location options available, contact the study inbox (ACCELERATE@nmdp.org) for assistance.

Age: [SYSTEM GENERATED]
This field should auto-populate once the Collection Date and Time and Lab Location fields are completed. If this field does not auto-populate, ensure that the age field is completed on the Demographics form. If not, complete the appropriate fields to derive the age, then navigate back to the Renal Assessment form. You can click Recalculate Age to refresh the field if needed.

Sex: [SYSTEM GENERATED]
This field should auto-populate from the Sex Assigned at Birth field on the Demographics form. If this field does not auto-populate, ensure that the sex field is completed on the Demographics form. If not, complete the sex field and submit the Demographics form, then navigate back to the Renal Assessment form.

Renal Assessment (CrCl)

Creatinine Clearance Lab Result:
Report the lab result and specify unit. Enter the result in “XXXXXXXXXXXXXX.XX” format. This format allows for up to 14 digits before the decimal and up to 2 digits after. If analyte resulted with a special character, select the appropriate option from the dropdown list before the analyte results box.

If analyte was not tested, check the “Missing Result” checkbox. Per protocol, creatinine clearance assessment is required at Screening. If Missing Result is reported, a protocol deviation should be logged in the EDC.

Normal Override:
Normals are pre-populated in the Normal column. You can override the current lab normal ranges by clicking Edit (pencil icon) in the Normal Override column and enter new Normal Ranges. A Reason for Override must be entered in order for the new normal range to be saved in the EDC.

CCG v1.0 | CRF v1.3

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