| Folder (Visit) or Form Name | Requirements | Recommended Date to Enter for Event Date |
|---|---|---|
| Enrollment Folder | Event Date entered | Date subject entered screening in RTSM |
| Screening Folder | Field “Did both recipient and donor meet study eligibility criteria” is answered Yes on Enrollment Confirmation form and Screening event date is entered | Screening Date NOTE: This date may be the same as the subject enrollment date |
| Conditioning Regimen Folder | Field “Did both recipient and donor meet study eligibility criteria” is answered Yes on Enrollment Confirmation form and Conditioning Regimen event date is entered | Start date of Conditioning regimen |
| Day 0 Folder | Field “Date study ICF signed” on Informed Consent form is not blank and field “Did both recipient and donor meet study eligibility criteria” is answered Yes on Enrollment Confirmation form and Day 0 event date is entered | Date of PBSC Infusion |
| Day 7 Folder | Field “Date of infusion” is not blank on PBSC Infusion form and GVHD Prophylaxis and Treatment event date is entered and Day 7 event date is entered | Date of Day 7 follow-up visit |
| Day 14 Folder | Day 7 event date is entered and Day 14 event date is entered | Date of Day 14 follow-up visit |
| Day 21 Folder | Day 14 event date is entered and Day 21 event date is entered | Date of Day 21 follow-up visit |
| Day 28 Folder | Day 21 event date is entered and Day 28 event date is entered | Date of Day 28 follow-up visit |
| Day 35 Folder | Day 28 event date is entered and Day 35 event date is entered | Date of Day 35 follow-up visit |
| Day 42 Folder | Day 35 event date is entered and Day 42 event date is entered | Date of Day 42 follow-up visit |
| Day 49 Folder | Day 42 event date is entered and Day 49 event date is entered | Date of Day 49 follow-up visit |
| Day 56 Folder | Day 42 event date is entered and Day 56 event date is entered | Date of Day 56 follow-up visit |
| Day 63 Folder | Day 56 event date is entered and Day 63 event date is entered | Date of Day 63 follow-up visit |
| Day 70 Folder | Day 63 event date is entered and Day 70 event date is entered | Date of Day 70 follow-up visit |
| Day 77 Folder | Day 70 event date is entered and Day 77 event date is entered | Date of Day 77 follow-up visit |
| Day 84 Folder | Day 77 event date is entered and Day 84 event date is entered | Date of Day 84 follow-up visit |
| Day 91 Folder | Day 84 event date is entered and Day 91 event date is entered | Date of Day 91 follow-up visit |
| Day 100 Folder | Day 91 event date is entered and Day 100 event date is entered | Date of Day 100 follow-up visit |
| Day 180 Folder | Day 100 event date is entered and Day 180 event date is entered | Date of Day 180 follow-up visit |
| Day 270 | Day 180 event date is entered and Day 270 event date is entered | Date of Day 365 follow-up visit |
| Day 365 Folder | Day 270 event date is entered and Day 365 event date is entered | Date of Day 365 follow-up visit |
| Event Forms (Common Forms) • Adverse Events • Concomitant Medications • Unanticipated Problem • Re-consent • Off Protocol • Study Exit / Study Completion • Medical History • Protocol Deviation • Death Data • Tacrolimus Administration • Mycophenolate mofetil (MMF) Administration • Abatacept Administration • Ruxolitinib Administration • Infection • Cytokine Release Syndrome |
Field “Date study ICF signed” on Informed Consent form is not blank and both Subject and Donor are eligible for the study | N/A – No Event Date for Common Forms |
CCG v1.0 | CRF v1.3
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