This form must be completed for all recipients of cellular therapy (non-HCT), including standalone infusions and post-HCT infusions, selected for CRF reporting level. It will be completed in conjunction with the Pre-Cellular Therapy Essential Data (Pre-CTED) (4000) form. For more information on TED and CRF level reporting is available in Data Management Guide, Cell therapy reporting tracks and follow up schedules.
The Pre-Cellular Therapy Baseline Data (4001) form will come due if the infusion is selected for CRF reporting level. This form captures pre-infusion data such as: setting for the infusion, toxicity prophylaxis, and socioeconomic information. The Baseline Form is due within 30 days after infusion.
Links to sections of form:
Q1-4: Product Identification
Q5-8: Toxicity Prophylaxis
Q9-27: Hematologic Findings Prior to Lymphodepleting Therapy
Q28-31: Socioeconomic information
Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
To reference the historical Manual Change History for this form, review the retired manual section on the Retired Forms Manual webpage.
Section Updates:
| Date of Change | Manual Section | Add/Remove/Modify | Description |
|---|---|---|---|
| 1/23/2026 | 4001: Pre-Cellular Therapy Baseline Data | Add | Version 2 of the Cellular Therapy Essential Data Pre- Infusion section of the Forms Instructions Manual released. Version 2 corresponds to revision 2 of the Form 4001. |
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