All transplant centers participating in the CIBMTR must submit a Pre-TED Form for each allogeneic (related or unrelated) hematopoietic cell transplant (HCT). The Pre-TED is a requirement of the SCTOD for all United States transplant centers when either the stem cell donation or the transplant occurs within the United States. For more information regarding the SCTOD, see General Instructions, Stem Cell Therapeutics Outcomes Database.
Although data regarding recipients receiving autologous HCT are not required to be submitted as part of the C.W. Bill Young Transplant Program, the CIBMTR is highly committed to collecting data on these recipients for research studies. Centers choosing to report autologous data to the CIBMTR must report on all autologous transplants performed at their center. For more information regarding data reporting for autologous HCT, see HCT
The Pre-TED may be submitted to the CIBMTR up to two weeks prior to the start of the recipient’s preparative regimen (see Helpful Hint below). The Pre-TED is due the day of the HCT (day 0), and is past due if not received by that date.
For recipients receiving a subsequent HCT:
Transplant centers must submit a Pre-TED for all subsequent HCTs; this includes recipients assigned to the TED Forms and the Comprehensive Report Forms by the form selection algorithm.
For the majority of subsequent HCTs, the recipient will remain on the original follow-up form track assigned by the form selection algorithm. For more information regarding center type and the form selection algorithm, see Section 1 in the Center Reference Guide. A recipient may need to change tracks if enrolled on a study that requires comprehensive forms.
For recipients of multiple transplants, transplant centers are not granted access to the new Pre-TED Form in FormsNet3 until the Post-TED (Form 2450) or Post-Infusion Data Form (Form 2100) from the previous transplant has been completed.
Transplant centers can use the FormsNet3 application to determine if a Pre-TED is due by either: 1) accessing the Forms Due Report, or 2) entering the recipient’s unique ID (CRID) in the Patient Forms Due field.
Q1-23: Recipient Information
Q24-43: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy
Q44-82: Donor Information
Q83-86: Clinical Status of Recipient Prior to the Preparative Regimen
Q87-115: Co-morbid Conditions
Q116-130: Pre-HCT Preparative Regimen
Q131-139: Additional Drugs Given in the Peri-Transplant Period
Q140-142: GVHD Prophylaxis
Q143-145: Post-HCT Disease Therapy Planned as of Day 0
Q146: Prior Exposure: Potential Study Eligibility
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.
|5/6/2021||2400: Pre-TED||Add||Clarification added to question 55 that a 2004 and 2005 form will not come due when the product is facilitated by NMDP|
|4/28/2021||2400: Pre-TED||Add||Clarification added on how to report a psychiatric comorbidity when treatment is given “as needed”: The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks. Do not report a psychiatric comorbidity if therapy was given “as needed” for any mood, anxiety, or other psychiatric disorder.|
|3/8/2021||2400: Pre-TED||Modify|| Blue note box above questions 102-111 updated: Complete questions 102 – 111 using the results measured within four weeks prior to the
|1/25/2021||2400: Pre-TED||Modify||Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.|
|1/22/2021||2400: Pre-TED||Modify||Version 7 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 7 corresponds to revision 8 of the Form 2400.|
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