To access follow-up visit CRFs, click on the Enter Date box and enter the date of the study visit. Click Continue. If the date entered is a future date, a query will appear in the EDC.
Was G-CSF administered in accordance with the protocol?:
Report if G-CSF (filgrastim) or a biosimilar was administered on Day +5 in accordance with the protocol.
Granulocyte colony-stimulating factor (G-CSF) to accelerate neutrophil recovery should be administered starting at Day +5 with dose, route of administration, formulation, and duration of administration following institutional guidelines. Filgrastim biosimilars are permissible, but granulocyte-macrophage colony-stimulating factors are not permissible.
If No, answer the below questions.
Specify reason G-CSF was not administered in accordance with protocol:
This field will only appear in the EDC if “Was G-CSF administered in accordance with the protocol?” is answered No. Report the reason G-CSF was not administered in accordance with protocol (up to 200 characters).
Specify G-CSF dosing and/or administration deviation that was given:
This field will only appear in the EDC if “Was G-CSF administered in accordance with the protocol?” is answered No. Report the G-CSF dosing and/or administration deviation from the protocol (up to 200 characters).
Was GM-CSF administered?:
Report if granulocyte- macrophage colony stimulating factors (GM-CSF) were administered.
Per protocol, granulocyte- macrophage colony stimulating factors (GM-CSF) are not permissible. If this field is answered Yes a protocol deviation should be logged in the EDC.
CCG v1.0 | CRF v1.3
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