To access follow-up visit CRFs, click on the Enter Date box and enter the date of the study visit. Click Save. If the date entered is a future date, a query will appear in the EDC.
Chimerism studies are performed to determine the percent of blood cells post-transplant that are produced from donor stem cells and the percent that are produced from host (recipient) stem cells. Different types of blood cells and a variety of laboratory tests can be used to determine if a chimera (presence of both donor- and host-derived cells) exists. If the donor and recipient are different sexes, cytogenetic testing (e.g., FISH or karyotype) may be used to determine if a chimera exists. Chimerism testing may also be performed by molecular methods (e.g., STR or VNTR).
Per protocol, donor chimerism evaluation should be obtained via bone marrow or peripheral blood in CD3 blood cell fraction or whole blood cell fraction.
Was chimerism testing performed?:
Report if chimerism testing was performed. Per protocol, assessment is required at this timepoint. If chimerism testing was not performed, a protocol deviation should be logged in the EDC.
Date chimerism sample collected:
This field will appear in the EDC if “Was chimerism testing performed?” is answered Yes. Report the date the chimerism 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.
Date should be within the specified visit window in the protocol. If the collection date entered is outside of visit window a protocol deviation will be logged in the EDC.
If the date entered is a future date, a query will appear in the EDC.
Chimerism Sample Source:
This field will appear in the EDC if “Was chimerism testing performed?” is answered Yes. Report the chimerism sample source as Bone Marrow or Peripheral Blood.
Unsorted/Whole blood chimerism:
This field will appear in the EDC if “Was chimerism testing performed?” is answered Yes. Report the chimerism result (unsorted/whole blood cells) in % donor cells (up to 5 characters).
T cells: CD3+ chimerism:
This field will appear in the EDC if “Was chimerism testing performed?” is answered Yes. Report the chimerism result (CD3+ cells) in % donor cells (up to 5 characters).
Myeloid cells: CD33+ chimerism:
This field will appear in the EDC if “Was chimerism testing performed?” is answered Yes. Report the chimerism result (CD33+ cells) in % donor cells (up to 5 characters).
CCG v1.0 | CRF v1.3
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