2400: Pre-TED

*The Pre-TED Form is now required for all transplants, including subsequent transplants on the comprehensive report form track.

All transplant centers participating in the CIBMTR must submit a Pre-TED (2400) 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 HCTs 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, review HCT in the Data Management Guide.

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).

*Helpful Hint:
In order to avoid having to make changes to the HCT date, complete the data for the Pre-TED (in FormsNet3^SM or on paper), but do not submit the form until the first dose of the preparative regimen is given.

!Consent Status and Baseline Forms
There has been a change to the functionality of submitting the Pre-Transplant Essential Data (2400), Pre-Transplant Essential Data Disease Classification (2402), and Pre-Cellular Therapy Essential Data (4000) forms. If a consent status has not yet been reported for a recipient, the edit form icon will appear disabled (see Figure 1 below). When the user hovers over the icon, it will display that consent has not yet been reported for that recipient (see Figure 2 below). The user should go to the Consent Tool (see Navigation to the Consent Tool) and document the recipient’s consent status in order to enable the edit icon and allow for completion of the form.

Figure 1. Disabled Edit Form Icon

Figure 2. Hovered Text, Consent Not Yet Reported

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.

Links to Sections of the Form:
Q1 – 21: Recipient Information
Q22 – 41: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy
Q42 – 80: Donor Information
Q81 – 86: Clinical Status of Recipient Prior to the Preparative Regimen
Q87 – 119: Comorbid Conditions
Q120 – 134: Pre-HCT Preparative Regimen
Q135 – 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
Q147 – 157: COVID-19 (SARS-CoV-2) Impact on Hematopoietic Cell Transplantation

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.

If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals webpage.

Date	Manual Section	Add/Remove/Modify	Description
4/19/2024	2400: Pre-TED	Remove	Instructions reporting weight prior to prep updated in Q121: Report the recipient’s body weight just prior to the start of the preparative regimen as documented on the transplant (for radiation and/or systemic therapy) or admitting orders. The intent of this question is to report the weight used to calculate the preparative regimen drug doses. This weight may also be the same weight reported on the Recipient Baseline (2000) Form, if applicable. Report weight to the nearest tenth of a kilogram or pound. Do not report adjusted body weight, lean body weight, or ideal body weight. Even if the recipient does not receive a preparative regimen, the weight is still required.
4/19/2024	2400: Pre-TED	Modify	The Diagnosis of COVID-19 After the Start of the Preparative Regimen blue box removed and the COVID-19 Infection red box added above Q87 to clarify these questions are now disabled.
4/19/2024	2400: Pre-TED	Modify	The COVID-19 Vaccine red box updated above Q90 to clarify these questions are now disabled.
4/15/2024	2400: Pre-TED	Remove	Instructions reporting weight prior to prep updated in Q121 due to missing a sentence with the previous 4/3/2024 update: Report the recipient’s body weight just prior to the start of the preparative regimen as documented on the transplant (for radiation and/or systemic therapy) or admitting orders. The intent of this question is to report the weight used to calculate the preparative regimen drug doses. This weight may also be the same weight reported on the Recipient Baseline (2000) Form, if applicable. Report weight to the nearest tenth of a kilogram or pound. Do not report adjusted body weight, lean body weight, or ideal body weight. Even if the recipient does not receive a preparative regimen, the weight is still required.
4/4/2024	2400: Pre-TED	Add	Plasma vs Serum Samples blue box added above Q106
4/3/2024	2400: Pre-TED	Modify	Instructions for reporting the weight prior to prep were updated in Q121: Report the recipient’s actual body weight just prior to the start of the preparative regimen as documented on the transplant (for radiation and/or systemic therapy) or admitting orders. The intent of this question is to report the actual weight used to calculate the preparative regimen drug doses. This may be the same weight reported on the Recipient Baseline (2000) Form. at the time the preparative regimen starts (which may be different than the weight used to determine preparative regimen doses). This weight is usually documented on the transplant orders (for radiation and/or systemic therapy) or admitting orders. Report weight to the nearest tenth of a kilogram or pound. Do not report adjusted body weight, lean body weight, or ideal body weight.
3/13/2024	2400: Pre-TED	Modify	The red warning box above Q147 updated to clarify this section is now disabled and will be updated with the next revision of the Pre-TED (2400) form.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q76: Omidubicel and Orca-T Products: If the product is Omidubicel, report the number of products intended to achieve hematopoietic engraftment as two and complete two HCT Product and Infusion (2006) forms. If the product is Orca-T, report the number of products intended to achieve hematopoietic engraftment as one and complete one HCT Product and Infusion (2006) forms and two Cellular Therapy Product (4003) forms.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q75: Omidubicel and Orca-T Products: If the product is Omidubicel, report the number of products from the donor as two. If the product is Orca-T, report the number of products from the donor as three.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q47: Omidubicel and Orca-T Products: If the product is Omidubicel or Orca-T, report No, the product was not genetically modified.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q45: Omidubicel and Orca-T Products: If the product is Omidubicel, report the product type as CBU. If the product is Orca-T, report the product type as BM.
3/8/2024	2400: Pre-TED	Add	Omidubicel and Orca-T Products blue box added above Q42: Omidubicel and Orca-T Products: If the product is Omidubicel or Orca-T, select No for multiple donors.
2/21/2024	2400: Pre-TED	Add	ATG / Campath blue note box added above Q106
12/4/2023	2400: Pre-TED	Remove	Removed the Cord Blood Units and Ex-vivo Expansion blue box: Cord Blood Units and Ex-vivo Expansion If the product is a cord blood unit that was ex-vivo expansion was performed, select Other product and specify ‘ex-vivo cord blood unit’ along with the method of expansion (examples of expansion methods include, but are not limited to, with omidubicel, with UM171, or on mesenchymal stem cells).
10/25/2023	2400: Pre-TED	Modify	Navigation instructions updated: Continue with Specify number of products infused from this donor What agents were used to mobilize the autologous recipient for this HCT if the donor type is autologous.
8/28/2023	2400: Comorbid Conditions:	Remove	Condensed comorbidity instructions listed in Q100 and 101 Appendix J
8/6/2023	2400: Pre-TED	Add	The Canadian Cancer Trials Group red warning box was above Q16: Canadian Cancer Trials Group Do not report Canadian Cancer Trials Group (CCTG) trials.
7/28/2023	2400: Pre-TED	Add	Instructions updated in Q79 – 80 on how to report product name due to specific products being added to the form: Report the name of the product. If the name is not listed, select Other name and specify the gene therapy product name.
7/28/2023	2400: Pre-TED	Add	Updated instructions in Q17-18 to clarify RCI-BMT is now known as CIBMTR CRO Services: Select the study sponsor of the clinical trial the recipient is participating in. If the participant is enrolled in multiple studies, even if from the same sponsor, report each study separately. If the study sponsor is reported as BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), or PIDTC, continue with Study ID Number.
7/28/2023	2400: Pre-TED	Add	Clarified in Q19 response options will remain the same, even though the RCI-BMT has been updated to CIBMTR CRO Services: Enter the BMT-CTN, RCI-BMT, or PIDTC study ID number of the recipient. Although the RCI-BMT study sponsor name has been updated to CIBMTR CRO Services, existing study ID options will remain listed as RCI-BMT. The new title CIBMTR CRO Services will be used as new studies are added to the option list.
7/19/2023	2400: Pre-TED	Modify	Updated instructions on what relapse date to report when the reason for subsequent HCT is recurrent primary disease in Q31-35: Recurrent primary disease: Additional stem cells are required because of relapse primary disease (i.e., complete remission was achieved pre- or post-transplant, but the disease relapsed following the previous transplant). If the reason is recurrent primary disease, continue with Date of relapse and report the relapse date. If multiple relapses have occurred since the previous infusion, report the date of the most recent relapse. Ensure that the date of recurrent primary disease matches the relapse/progression date reported on the previous transplant’s appropriate follow-up form.
7/19/2023	2400: Pre-TED	Add	Therapy Clinical Trials red warning box added above Q16: Therapy Clinical Trials Do not report clinical trials for induction / consolidation / salvage therapy (excluding clinical trials sponsored by COG or if the recipient is enrolled on the PedAL study, COG APAL2020SC), blood / tissue sample collection, or any trial the recipient is enrolled post-HCT.
7/19/2023	2400: Pre-TED	Modify	Clarified which clinical trials should be reported in Q16: For the infusion being reported on this form, indicate if the recipient is a registered participant of a key treatment clinical trial pre or post infusion regardless of if that sponsor uses CIBMTR forms to capture outcomes data. Only clinical trials relating to the HCT intervention and are known and consented at the time of HCT should be reported. This includes trials related to, but not limited to, the graft source, GVHD prophylaxis, or the preparative regimen. Examples of pre-infusion key treatment clinical trials include cooperative group initial treatment trials (i.e., Alliance, ECOG-ACRIN, SWOG, and COG), cooperative group relapse treatment trials, and transplant trials. Report any clinical trial, including upfront or relapse chemotherapy, only if the sponsor is COG or if the recipient is enrolled on the PedAL study, COG APAL2020SC If the recipient is a registered participant of key treatment clinical trials and enrolled post-infusion, the Pre-TED (2400) should be updated to reflect the post-infusion trials. Examples of post-infusion key treatment clinical trials include the Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) and MAGIC consortium.
7/19/2023	2400: Pre-TED	Modify	Clinical trials blue box updated above Q16: Clinical Trials As of the April 2023 release, pre or post infusion key treatment clinical trials regardless of if the sponsor uses CIBMTR forms to capture outcomes data should are now reported on the Pre-TED (2400) Form, regardless of if the sponsor uses CIBMTR forms to capture outcomes data. Review the instructions below for additional information on key treatment clinical trials. Corporate / industry trials or investigator-initiated trials should be reported under Other.
5/1/2023	2400: Pre-TED	Add	Clinical trials blue box added above Q16: Clinical Trials As of the April 2023 release, and pre- or post-infusion key treatment clinical trials should now be reported on the Pre-TED (2400) Form, regardless of if the sponsor uses CIBMTR forms to capture outcomes data. Review the instructions below for additional information on key treatment clinical trials. Corporate / industry trials or investigator-initiated trials should be reported under Other.
5/1/2023	2400: Pre-TED	Modify	Instructions for reporting clinical trials updated as part of the Spring 2023 release: Indicate if the recipient is a registered participant of a key treatment clinical trial pre- or post-infusion. Examples of pre-infusion key treatment clinical trials include cooperative group initial treatment trials (i.e., Alliance, ECOG-ACRIN, SWOG, and COG), cooperative group relapse treatment trials, and transplant trials with BMT-CTN, RCI-BMT, USIDNET, COG, PedAL and/or another clinical trial sponsor that uses CIBMTR forms to capture outcomes data. If the recipient is a registered participant of key treatment clinical trials and enrolled post-infusion, the Pre-TED (2400) should be updated to reflect the post-infusion trials. Examples of post-infusion key treatment clinical trials include the Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) and MAGIC consortium. Sponsors include but are not limited to, BMT-CTN, RCI-BMT, USIDNET, COG, and PedAL. Report corporate / industry trials or investigator-initiated trials as an Other clinical trial sponsor. BMT-CTN: Blood and Marrow Transplant Clinical Trials Network RCI-BMT: Resource for Clinical Investigation in Blood and Marrow Transplant PIDTC: Primary Immune Deficiency Treatment Consortium USIDNET: United States Immunodeficiency Network COG: Children’s Oncology Group PedAL: LLS PedAL Other: Corporate / industry or investigator initiated The Other sponsor option should rarely be used. Do not report any transplant center specific clinical trials or investigator-initiated trials the recipient is participating at the transplant center. If the recipient is participating in a clinical trial but does not use CIBMTR form to capture outcomes data and does not fit in one of the specified options listed, contact CIBMTR Customer Support. If the recipient is not participating in a clinical trial, select No. Submit a ticket through CIBMTR Center Support when there are questions on reporting clinical trials.
5/1/2023	2400: Pre-TED	Add	Peri-transplant time frame defined: Drugs may be given during the peri-transplant (before and after infusion). period to prevent transplant-related complications, such as liver injuries or to facilitate engraftment. For each agent listed, indicate whether the drug was administered during the peri-transplant period to prevent transplant-related complications or facilitate engraftment, and any additional question(s) for each drug administered. ALG (Anti-Lymphocyte Globulin), ALS (Anti-Lymphocyte Serum), ATG (Anti-Thymocyte Globulin, ATS (Anti-Thymocyte Serum): Serum or gamma globulin preparations containing polyclonal immunoglobulins directed against lymphocytes. These drugs are usually prepared from animals immunized against human lymphocytes. Report the total dose prescribed pre- and post-infusion and the animal source. If Other is selected, specify the source. Alemtuzumab (Campath): Antibody preparations that are infused in the recipient. Report the total dose prescribed pre- and post-infusion to the nearest tenth and specify the units of measurement.
5/1/2023	2400: Pre-TED	Add	Cord Blood Units and Ex-vivo Expansion blue box added add to Q45: Cord Blood Units and Ex-vivo Expansion If the product is a cord blood unit that was ex-vivo expansion was performed, select Other product and specify ‘ex-vivo cord blood unit’ along with the method of expansion (examples of expansion methods include, but are not limited to, with omidubicel, with UM171, or on mesenchymal stem cells).
2/15/2023	2400: Pre-TED	Remove	Instructions for reporting the height prior to prep were updated: Report the recipient’s height just prior to the start of the preparative regimen. The intent of this question is to determine the height used when calculating preparative regimen drug doses. This height is usually documented on the transplant orders (for radiation and/or systemic therapy) or admitting orders. Report height to the nearest whole centimeter or inch (round up if 0.5 or greater).
10/20/2022	2400: Pre-TED	Add	Instructions for Q17 – 18 updated to include PedAL option: If the study sponsor is reported as USIDNET, COG, or PedAL continue with Subject ID.
10/20/2022	2400: Pre-TED	Add	Instructions for Q16 updated to include PedAL option: Indicate if the recipient is a registered participant with BMT-CTN, RCI-BMT, USIDNET, COG, PedAL and/or another clinical trial sponsor that uses CIBMTR forms to capture outcomes data. BMT-CTN: Blood and Marrow Transplant Clinical Trials Network RCI-BMT: Resource for Clinical Investigation in Blood and Marrow Transplant PIDTC: Primary Immune Deficiency Treatment Consortium USIDNET: United States Immunodeficiency Network COG: Children’s Oncology Group PedAL: LLS PedAL
10/18/2022	2400: Pre-TED	Add	Clarification added on how to answer Q135 – 139 when peri-transplant drugs were not given: If the recipient did not receive any of the drugs listed above, leave these questions blank and override the error as ‘verified correct.’
9/23/2022	2400: Pre-TED	Modify	Version 9 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 9 corresponds to revision 10 of the Form 2400.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.