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.
Q1-25: Recipient Information
Q26-45: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy
Q46-83: Donor Information
Q84-87: Clinical Status of Recipient Prior to the Preparative Regimen
Q88-116: Comorbid Conditions
Q117-131: Pre-HCT Preparative Regimen
Q132-140: Additional Drugs Given in the Peri-Transplant Period
Q141-143: GVHD Prophylaxis
Q144-146: Post-HCT Disease Therapy Planned as of Day 0
Q147: 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.
|11/23/2020||2400: Pre-TED||Modify|| Questions 1 – 5 were updated to explain the CRID Assignment tool should be corrected if an error is identified in these data fields as these data are automatically populated based on what is reported in the CRID Assignment tool: The date of birth is automatically populated based on the value reported in the CRID Assignment
|11/23/2020||2400: Pre-TED||Add||Information added on how to report infection comorbidities in question 97: Infection: Documented infection, fever of unknown origin, or pulmonary nodules requiring continuation of antimicrobial / antifungal / antiviral treatment after day 0.|
|11/23/2020||2400: Pre-TED||Add||Clarification (blue information box) was added to question 119 to clarify MIBG therapy should not be reported as preparative regimen: MIBG Therapy: MIBG therapy given for recipients with neuroblastoma is no longer considered preparative regimen and should not be reported.|
|11/23/2020||2400: Pre-TED||Modify|| The instructions for question 87 were updated to include when to use the “indeterminant” option for CMV testing: If the laboratory reports the results as “inconclusive” or “equivocal,” select “
Indicate the test result documented on the laboratory report as either “reactive,” “non-reactive,” “indeterminant,” or “not done.”
|10/23/2020||2400: Pre-TED||Add|| Added the following guidance on answering question 60:
Question 60 has been “hidden” in FormsNet3 for the current revision of this form. If an NMDP donor ID had been previously entered, this field will not be hidden and can be edited as needed. However, if an NMDP donor ID has not been entered yet, this field will be hidden and skipped until the form is revised and the question is removed from the form.
|10/23/2020||2400: Pre-TED||Add|| Added the following guidance on answering questions 17 and 18:
Questions 17 and 18 should only be completed for recipients who received an allogeneic transplant. If the recipient received an autologous transplant, these questions should be left blank.
|10/14/2020||2400: Pre-TED||Add||Clarification added to question 96 on how to report a pulmonary comorbidity when both a “control” FEV1 and “post-dilator” FEV1 is available.|
|9/10/2020||2400: Pre-TED||Add||An example added to question 80 to explain how to report the number of products infused when there is a change in mobilization: Example 2 (change in mobilization): A G-CSF stimulated donor had a PBSC collection, but the cell count was poor. Plerixafor (Mozobil) was added as part of the mobilization and the donor was re-collected the following day. As the change in mobilization occurred during the same mobilization cycle, these collections are considered a single product.|
|9/9/2020||2400: Pre-TED||Add||Clarification added on how to report ADD and ADHD as comorbidities: Psychiatric disturbance – 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.|
|8/26/2020||2400: Pre-TED||Add||Blue information box added above question 88 to explain how to report COVID-19 infections when diagnosed after the start of the preparative regimen: Diagnosis of COVD-19 after the start of the preparative regimen: Questions 88 – 90 are intended to capture COVID-19 (SARS-CoV-2) infections diagnosed prior to the start of the preparative regimen / infusion. If a COVID-19 infection is diagnosed after the start of the preparative regimen, report the COVID-19 diagnosis on the post-infusion follow-up form (2450, 2100, and / or 4100).|
|8/18/2020||2400: Pre-TED||Add||Provided clarification for question 121 on how to report radiation boosts: Additionally, “radiation boosts,” often given to smaller sites that may have residual malignant cells or to areas that were shielded (i.e., chest wall or lung), should not be reported in this section. Report irradiation boosts administered on the applicable Recipient Baseline Data (2000) Form.|
|7/31/2020||2400: Pre-TED||Add||Provided clarification to question 51 on what to select if the infusion is gene therapy: If the infusion is a gene therapy, select “yes.”|
|7/8/2020||2400: Pre-TED||Modify|| Updated the time frame for reporting biomarkers in questions 103 – 112 (the blue information box) to be consistent with the augmented HCT comorbidity index: Complete questions 103 – 112 using the results measured the closest
|6/12/2020||2400: Pre-TED||Modify|| Updated the instructions on how to report intrathecal therapy as part of preparative regimen in question 127 – 128 to be consistent with Recipient Baseline (2000) manual: The “other drug” category should be used only if the drug is not one of the listed options. If an “other” drug is prescribed, list the name of the drug in question 128. Include any intrathecal drugs the recipient received for prophylaxis or treatment of CNS disease within
|6/11/2020||2400: Pre-TED||Modify|| Updated the instructions for question 120 on when the CIBMTR’s guidelines should be used to report the preparative regimen classification by removing (strike through text) and adding (red text) the following:
|6/9/2020||2400: Pre-TED||Add||Added clarification (red text) on how to report heart valve comorbidity for question 97. Moderate or severe valve stenosis or insufficiency (mitral, aortic, tricuspid, or pulmonary) as determined by the most recent heart evaluation by an echocardiogram, prosthetic mitral or aortic valve, and / or symptomatic mitral valve prolapse. This does not include a documented medical history of heart valve disease.|
|5/28/2020||2400: Pre-TED||Modify||Provided additional clarification on how to report the GFR if a range, “< X” or “> X” is listed and when the GFR calculator may be used.|
|5/21/2020||2400: Pre-TED||Modify||Provided additional clarification on how to report the ordered dose when pharmacokinetic testing is performed in question 129.|
|5/13/2020||2400: Pre-TED||Remove||Removed the word “proven” from question 92 guidance. Removed verbiage from paragraphs defining “proven”.|
|5/9/2020||2400: Pre-TED||Modify||Version 6 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 6 corresponds to revision 7 of the Form 2400.|
|5/7/2020||2400: Pre-TED||Add||For question 11, added the following guidance on zip codes: The zip or postal code is required for USA residents. The postal code is optional for Canadian residents. The question can be answered or left blank without error for Canadian residents.|
|4/7/2020||2400: Pre-TED||Add||For question 85-86, added the following guidance on Karnofsky/Lansky score documentation: Documentation from an RN who has been trained and authorized to determine performance scores may also be used.|
|4/6/2020||2400: Pre-TED||Remove||Removed the word “unrelated” from question 60, which now reads NMDP donor ID.|
|3/23/2020||2400: Pre-TED||Modify||In the Q88-113: Comorbid Conditions section, updated cardiac reporting guideline for congestive heart failure to include guidance on LVEF.|
|3/23/2020||2400: Pre-TED||Add||In the Q88-113: Comorbid Conditions section, added guidance to obesity reporting guideline for calculating BMI-for-age for pediatric patients.|
|3/20/2020||2400: Pre-TED||Modify||In the Q46-83: Donor Information section, updated instructions for question 51 to include more specific criteria for a genetically modified product.|
|3/6/2020||2400: Pre-TED||Modify||In Q114-128: Pre-HCT Preparative Regimen section, updated instructions for question 124 – 125 to report drug doses to the nearest tenth.|
|3/6/2020||2400: Pre-TED||Modify||In Q114-128: Pre-HCT Preparative Regimen section, updated instructions for question 115 to report weight to the nearest tenth of a kilogram.|
|3/6/2020||2400: Pre-TED||Modify||Moved “arrhythmia” designation after question 93 in sectionQ88 – 113: Comorbid Conditions in the Documented Medical History list. Removed “other” listing after “Current Diagnosis at the Time of Pre-HCT Evaluation” list.|
|1/24/2020||2400: Pre-TED||Modify||Version 5 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 5 corresponds to revision 6 of the Form 2400.|
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