2023 Manual Updates

January 2023
February 2023
April 2023
May 2023
June 2023
July 2023
August 2023
September 2023
October 2023
November 2023
December 2023

Updates made during the current calendar year are included below. For updates prior to 2023, click on the subtopic corresponding to the year of interest. If you need to reference an archived manual section for a retired form, please refer to the Retired Forms Manuals webpage.

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December 2023

12/20/2023	Appendix J: Reporting Comorbidities	Add	Clarification added for mild hepatic criteria: Hepatic, mild: Any one or more of the following: Chronic hepatitis Any diagnosed history of Hepatitis B or Hepatitis C
12/19/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Time frame for reporting the 1Y contact date updated in the Contact Date table in Q2: _F4100 , 1 Year, + 60 days (Day 36 5 6 – 425)
12/19/2023	2100:Post-Infusion Follow-Up Form	Modify	Q1 instructions update to clarify the contact date for the 1Y reporting period must be greater than day 365: Reporting the 1-Year Date of Contact: If this form is being completed for the 1-year reporting period, ensure the reported contact date is > ≥ Day 365. Review the 1-Year Date of Contact instructions below for additional information.
12/19/2023	2450: Post-TED	Modify	Q1 instructions update to clarify the contact date for the 1Y reporting period must be greater than day 365: Reporting the 1-Year Date of Contact: If this form is being completed for the 1-year reporting period, ensure the reported contact date is > ≥ Day 365. Review the 1-Year Date of Contact instructions below for additional information.
12/19/2023	2450: Post-TED	Add	Q110 instructions updated to clarify relapse / progression therapy is not reported when treatment begins in the reporting period after which relapse / progression was first reported in: Indicate whether therapy was given during the reporting period for persistent or relapsed / progressive disease. Do not include therapy given for maintenance or planned post-transplant consolidation. Any post-transplant therapy included as part of the initial transplant protocol should not be reported in this area of the form. If treatment for relapse / progression started after the reporting period in which relapse / progression was first reported in, the _intervention for relapse / persistent / progressive disease data fields are disabled and relapse / progression treatment is not captured. See the Intervention reporting scenarios provided below for further clarification._
12/19/2023	2018: LYM Pre-Infusion	Add	Zynlonta (Ioncastuximab) End Date blue box added above Q170: Zynlonta (Ioncastuximab) End Date: When only a single of the drug Zynlonta (Ioncastuximab) is given, report the therapy end date as the date 21 days post the therapy start date. If Zynlonta is given in multiple cycles, use the standard reporting instructions for reporting the therapy end date of multiple cycles
12/19/2023	Appendix O: Cellular Therapy Critical Fields	Remove	Removed Appendix O: Cellular Therapy Critical Fields. The CT Critical Data Fields Lists can be found in the Audit section of the CIBMTR Portal. An archived copy of this information can be found in the Retired Forms Manual section.
12/19/2023	Appendix M: HCT Critical Data Fields	Remove	Removed Appendix M: HCT Critical Data Fields. The HCT Critical Data Fields Lists can be found in the Audit section of the CIBMTR Portal. An archived copy of this information can be found in the Retired Forms Manual section.
12/19/2023	Appendix K: Key Fields	Remove	Removed Appendix K: Key Fields. An archived copy of this information can be found in the Retired Forms Manual section.
12/18/2023	2003: Gene Therapy Product	Add	Bone Marrow Products blue information box added above Q6: Bone Marrow Products: If the Gene Therapy product is mobilized from the bone marrow, select Not done for the questions Peripheral blood CD34+ cell count prior to first dose of cytokine for mobilization (baseline) and Peripheral blood CD34+ cell count on Day 1 apheresis, just prior to start of procedure.
12/12/23	4101: Post-Cellular Therapy Follow-Up	Modify	Reformatted and created an example: Example 1: A recipient has a CD19 expressing disease prior to the cell therapy infusion, such as acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL). The recipient is given a CD19-directed CAR T-cell therapy, achieves a CR then relapses. At the time of relapse their leukemia/lymphoma cells no longer express CD19.
12/12/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Select Not applicable when: The recipient never got immunoglobulin replacement therapy due to never having a decreased IgG level Or There was no decline in IgG levels in this reporting period Or IgG levels were never tested in this reporting period
12/12/23	4006: Cellular Therapy Infusion	Modify	Updated the definition of concomitant therapy: Concomitant therapy is any therapy given to increase the effectiveness of the cellular therapy or decrease the toxicity enhance the function of the cellular therapy
12/9/2023	2100:Post-Infusion Follow-Up Form	Add	Immunosuppressive Agents blue box added above Q209: Immunosuppressive Agents As of December 9, 2023, questions regarding if the recipient is still taking immunosuppressive agents are required to be answered for all allogeneic infusions, regardless of if GVDH developed.
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).

November 2023

11/21/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	DO report an infection in the following scenarios: A recipient has a positive COVID-19 diagnostic result (PCR or antigen) or if treatment was given or if the recipient was asymptomatic. regardless of if treatment was given or if the recipient was asymptomatic.
11/17/2023	2100:Post-Infusion Follow-Up Form	Add	Instructions added on how to report the resolution date for cardiomyopathy: _Indicate if the cardiac impairment / disorder resolved during the reporting period. If Yes, report the resolution date. For all cardiac impairment / disorders, except for cardiomyopathy, the resolution date is the date when the notes specify the condition as resolved and / or medications to treat the condition were completed. For cardiomyopathy, report the resolution date as the first date when the echocardiogram normalized, and the recipient is no longer receiving cardiomyopathy treatment. If an echocardiogram was not performed to assess the cardiomyopathy status, report the resolution date as the first date when treatment is no longer required and in the physician’s opinion, cardiomyopathy resolved.
11/6/2023	4001: Pre-Cellular Therapy Baseline Data	Add	Add blue box at top of section: If drugs given for toxicity prophylaxis were started at the time of cell therapy infusion, including after day zero, they should be reported in this section.

October 2023

10/27/2023	2100:Post-Infusion Follow-Up Form	Modify	Version 9 of the 2100: Post-Infusion Follow-Up section of the Forms Instructions Manual released. Version 9 corresponds to revision 9 of the Form 2100
10/27/2023	2450: Post-TED	Modify	Red warning box regarding reporting maximum organ staging was added: Due to further clarification provided, the instructions for reporting the maximum organ staging were updated with the Fall 2023 Quarterly Release. The intent of the maximum organ staging questions is to capture the maximum stage of each organ involved with acute GVHD in the reporting period; not at the time of the maximum overall grade, despite what the question text states. The question text will be revised with the next revision of the Post-Infusion Follow-Up (2100) Form. Additionally. instructions were updated to clarify the maximum stage in the reporting period should be reported, not the maximum stage at the time of the maximum grade of GVHD
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.
10/25/2023	2402: Disease Classification	Add	Added clarification language to the blue box located below Q494: Laboratory studies at last evaluation Complete the serum iron, TIBC, and total serum bilirubin questions based on the most recent testing prior to the start of the preparative regimen / infusion. Tests can be performed on different days.
10/17/2023	2402: Disease Classification	Modify	Updated questions 18, 45, 72, 118, 137, 156, 229, 266, 317, 374, 452 due to the enabling of the ISCN string data field with the Summer 2023 quarterly release: The International System for Human Cytogenetic Nomenclature (ISCN) compatible string is disabled and cannot be answered at this time Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable. Refer to Appendix C for more information on how to report using the ISCN functionality.
10/5/2023	Appendix J: Reporting Comorbidities	Add	Further clarification added for pediatric invasive fungal infections: Infection: Pediatrics: The presence of one or more of the following: - History of invasive fungal infection (refer to Is there a history of invasive fungal infection? manual instructions located under the 2400 Comorbid Conditions section for further clarification) - Infection requiring antimicrobial treatment continued after Day 0 Do not report an infection comorbidity if the infection resolved prior to infusion and there was a recommendation to continue, or the recipient continued medication post-infusion as prophylaxis
10/5/2023	Appendix J: Reporting Comorbidities	Add	Further clarification added for pediatric mechanical ventilation: Pulmonary, severe: Pediatrics: Any one or more of the following at the time of pre-infusion evaluation: - Adjusted DLCO ≤ 65% - FEV1 ≤ 65%** - Dyspnea at rest attributed to pulmonary disease and not anemia - Requires intermediate or continuous supplemental oxygen - History of mechanical ventilation (refer to Is there a history of mechanical ventilation? manual instructions located under the 2400 Comorbid Conditions section for further clarification) Do not report if intubated due to premature birth for <24 hours.
10/5/2023	2114: Q88-171: Most Recent Laboratory Studies	Modify	Provided clarity on how to report when no flow assessments were completed : Flow cytometry assessment is a method of analyzing peripheral blood, bone marrow, or tissue preparations for multiple unique cell characteristics; its primary clinical purpose in the setting of MDS, MPN, and leukemias is to quantify blasts in the peripheral blood or bone marrow, or to identify unique cell populations through immunophenotyping. Flow cytometry assessment may also be referred to as “MRD” or minimal residual disease testing. If the disease was detected via flow cytometry, select Yes and continue to the next question. If disease was not detected via flow cytometry, flow cytometry wasn’t performed at any time during the reporting period, or it is unknown if disease was detected via flow cytometry, select No and continue to Was disease detected via cytogenetic testing (karyotyping or FISH)?
10/5/2023	2114: Q88-171: Most Recent Laboratory Studies	Modify	Provided clarity on how to report when no bone marrow assessments were completed: If a bone marrow biopsy detected disease during the reporting period, report Yes for Was disease detected via bone marrow examination? and report the date of the positive assessment. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms. If multiple bone marrow biopsies detected disease, report the date of the earliest positive assessment performed during the reporting period. If bone marrow biopsies did not detect disease at any time during the reporting period report No. If no bone marrow biopsies were done during the reporting period, or it is unknown if any bone marrow biopsies were done, report “no” or Unknown respectively and go to Was extramedullary disease indicative of AML detected? (e.g. myeloid sarcoma).

September 2023

9/28/2023	2402 Q462 – 464: Severe Aplastic Anemia	Modify	Updated manual language for better clarification of severe / very severe Aplastic Anemia criteria Severe / Very Severe Requires two of more both of the following1: Bone marrow cellularity < 25% (or 25% to 50% if < 30% of residual cells are hematopoietic) and At least two of the following: Peripheral blood absolute neutrophil count (ANC) < 500 / µL (<0.5 x 109/L) Peripheral blood platelet count < 20,000 / µL Peripheral blood reticulocyte count < 20,000 / µL
9/15/2023	2450: Graft versus Host Disease	Modify	Instructions updated to clarify reporting the date of maximum grade of acute GVHD when there is organ staging variation: Report the first date of maximum acute GVHD involvement, based on clinical grade. If the recipient had multiple instances in which their GVHD reached the same maximum grade, report the earliest date, regardless of any variation in the organ staging. However, if the same maximum overall grade was achieved, but the specific organ staging varied, report the date of the maximum organ staging which is consistent with the overall grade reported in Maximum overall grade of acute GVHD question. For further clarification, review Acute GVHD grading scenario E above has been provided for further clarification.
9/15/2023	2450: Graft versus Host Disease	Modify	Updated Acute GVHD Grading Scenario E to reflect updated instructions of reporting the date of maximum grade when there is organ staging variation: E. A recipient developed stage 1 skin involvement and stage 1 liver involvement (overall grade II) on 1/1/2019 which resolved in response to topical steroids and tacrolimus steroids. Later in the reporting period, on 2/14/2019, they have a flare of the skin GVHD, this time at stage 2 3, along with GI stage 1 (overall grade II). In this case, grade II would be reported in question 29 as the Maximum overall grade of acute GVHD with the date of diagnosis of the more severe flare maximum date reported as 1/1/2019, the First date of maximum overall grade of acute GVHD. Additionally, the skin symptoms would be reported as stage 2 in question 31.when reporting the organ staging at the time of maximum overall grade, skin stage 1 and liver stage 1 should be reported. Skin stage 3 and GI stage 1 will not be captured.
9/15/2023	2100: Acute Graft vs. Host Disease	Modify	Instructions updated to clarify reporting the date of maximum grade of acute GVHD when there is organ staging variation: Report the first date of maximum acute GVHD involvement, based on clinical grade. If the recipient had multiple instances in which their GVHD reached the same maximum grade, report the earliest date, regardless of any variation in the organ staging. For further clarification, review acute GVHD grading scenario D above. If Not applicable was reported for Maximum overall grade of acute GVHD, this question must be left blank. If the same maximum overall grade was achieved, but the specific organ staging varied, report the date of the maximum organ staging consistent with the overall grade reported in Maximum overall grade of acute GVHD. For example, a recipient developed stage 2 liver GVHD that later progressed to stage 3 liver GVHD within the reporting period. The date the recipient had stage 3 liver GVHD should be reported as the date of maximum grade, even though stage 2 and stage 3 liver GVHD are both captured as grade 3.
9/15/2023	2100: Acute Graft vs. Host Disease	Add	Acute GVHD Grading Scenario D added to reflect updated instructions of reporting the date of maximum grade when there is organ staging variation: D. A recipient developed stage 1 skin involvement and stage 1 liver involvement (overall grade II) on 1/1/2019 which resolved in response to topical steroids and tacrolimus. Later in the reporting period, on 2/14/2019, they have a flare of the skin GVHD, this time at stage 3, along with GI stage 1 (overall grade II). In this case, grade II would be reported as the Maximum overall grade of acute GVHD with the maximum date reported as 1/1/2019 the first date of maximum overall grade of acute GVHD. Additionally, when reporting the organ staging at the time of maximum overall grade, skin stage 1 and liver stage 1 should be reported. Skin stage 3 and GI stage 1 will not be captured.
9/7/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Select Not applicable when: The recipient never got immunoglobulin replacement therapy due to never having a decreased IgG level Or There was no decline in IgG levels in this reporting period

August 2023

8/28/2023	Appendix J: Reporting Comorbidities	Add	Version 4 of Appendix J added. This version is an overhaul of the appendix for easier comorbidity reporting
8/28/2023	2400: Comorbid Conditions:	Remove	Condensed comorbidity instructions listed in Q100 and 101
8/28/2023	Q81-91: Comorbid Conditions	Remove	Condensed instructions for reporting comorbidities in Q92 and Q93
8/25/2023	2149: Respiratory Virus Post-Infusion Data	Modify	Updated the Respiratory Virus Post-Infusion Data (2149) form instructions to reflect that this form will no longer come due automatically or be available on-demand for recipients on the CRF or cellular therapy tracks when there is a diagnosis of COVID-19 post-infusion.
8/25/2023	2100: Post-Infusion Follow-Up	Modify	Diagnosis of COVID-19 after the start of the preparative regimen Any COVID-19 infections diagnosed after the start of the preparative regimen should be reported in the following questions on the Post-HCT Follow-Up (2100) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated. Effective August 25, 2023, the Respiratory Virus Post-Infusion Data (2149) form for transplants on the CRF track will no longer be required. Additionally, an unscheduled Respiratory Virus Post-Infusion Data (2149) form cannot be created for these recipients.
8/25/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Diagnosis of COVID-19 after the start of the lymphodepleting therapy: Any COVID-19 infections diagnosed after the start of the lymphodepleting therapy should be reported in the following questions on the Cellular Therapy Essential Data Follow-Up (4100) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated. Effective August 25, 2023, the Respiratory Virus Post-Infusion Data (2149) form for infusions on the cellular therapy track will no longer be required. Additionally, an unscheduled Respiratory Virus Post-Infusion Data (2149) form cannot be created for these recipients.
8/24/2023	4100: Cellular Therapy Essential Data Follow-Up	Add	If the recipient never got immunoglobulin replacement therapy and their immunoglobulin levels were never decreased, select Not applicable.
8/22/2023	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Clarified the intention of the question: Indicate if the recipient received pre-exposure drugs for COVID-19 in this reporting period.
8/22/2023	4100: Cellular Therapy Essential Data Follow-Up	Modify	Clarified the intention of the question: Indicate if the recipient received pre-exposure drugs for COVID-19 in this reporting period.
8/22/23	4101: Post-Cellular Therapy Follow-Up	Modify	Update: Many cellular therapies are designed to target a specific tumor antigen(s). One mechanism of resistance to these cellular therapies includes antigen escape. This is occurs when disease relapses and the tumor develops partial or complete loss of the tumor antigen. An example is a recipient with acute lymphoblastic leukemia (ALL) that expresses the CD19 antigen prior to cellular therapy infusion.
8/22/23	4101: Post-Cellular Therapy Follow-Up	Add	New blue note box added under question 5: Antigen escape occurs in the context of relapse.
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.
8/3/2023	2402: Disease Classification	Remove	Removed the word date from Q1 of the Hodgkin and Non-Hodgkin Lymphoma section: If the lymphoma transformed from CLL, report the diagnosis date of the lymphoma. The CLL diagnosis date will be captured below.
8/3/2023	2402: Disease Classification	Remove	Removed the word date from Q1 of the Other Leukemia section: Ensure the Hodgkin / Non-Hodgkin Lymphoma section is completed. The CLL diagnosis date is captured in the Hodgkin / Non-Hodgkin Lymphoma section.

July 2023

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.
7/28/2023	2000: Recipient Baseline	Add	Red warning box added above Q115 to clarify question is now disabled: Specify the recipient’s combined household gross annual income is disabled. This question will be updated with the next revision of the Recipient Baseline (2000) Form.
7/28/2023	Appendix C: Cytogenetics	Add	Version 3 of Appendix C: Cytogenetics released with the Summer 2023 Quarterly release
7/26/023	4006: Cellular Therapy Infusion	Add	New note box for Abecma® ] under Lot number: If the cellular therapy product infused is the commercially available product Abecma®, the lot number must be reported and is available on the Release for Infusion (RFI).
7/26/023	4006: Cellular Therapy Infusion	Modify	Added Abecma® and BreyanziTM to the blue note box under Batch number: If the cellular therapy product infused is the commercially available product Yescarta®, Tecartus®, Abecma®, or BreyanziTM do not report a batch number.
7/20/2023	2450: Post-TED	Add	Clarification added on how to report haplo cords chimerism in Q60-74: When reporting chimerism studies for multiple donors, there should be one instance for each donor for each chimerism test results. For haplo cords, (i.e., haplo donor PBSC and CBU), there should be an instance for both the CBU and the PBSC.
7/19/2023	Multiple Myeloma Response Criteria	Add	Image 1 Urine Studies Requirement graphic added
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.
7/19/2023	2542: Mogamulizumab Supplemental Data Collection	Modify	Clarified when the 2542 will come due in the introduction section: The Mogamulizumab Supplemental Data Collection Form will come due for all recipients enrolled on the study, irrespective of Mogmulizumab administration status. This includes recipients on the Case arm, those each patient who received Mogamulizumab one year prior to or 18 months post allo HCT and recipients on the Control arm, those who satisfy the study eligibility criteria except Mogamulizumab administration. The 2400 and 2402 will confirm eligibility, this includes event date, age at event, disease subtype, and type of infusion. Once eligibility is confirmed, the 2500 and 2542 will come due. The 2500 will confirm use of Mogamulizumab pre-transplant, triggering the 2542.
7/19/2023	3500: Subsequent Neoplasms	Add	PTLD blue info box added and clarified PTLD should be reported as NHL in Q1: Post-Transplant Lymphoproliferative Disorder (PTLD) PTLD should be reported as a new malignancy if it was confirmed via a biopsy (treatment not required) or suspected to be PTLD and treated Indicate which new malignancy / disorder was diagnosed during the reporting period and any applicable questions. If the new malignancy / disorder is not found in the list, select Other new malignancy and report the malignancy in question 8. An example of an Other new malignancy includes histiocytic sarcoma. Report myeloid sarcoma as Acute myeloid leukemia (AML / ANLL). Report post-transplant lymphoproliferative disorder (PTLD) as NHL.
7/19/2023	2100:Post-Infusion Follow-Up Form	Add	Blue PTLD info box added to Q311: Post-Transplant Lymphoproliferative Disorder (PTLD): PTLD should be reported as a new malignancy if it was confirmed via a biopsy (treatment not required) or suspected to be PTLD and treated.
7/19/2023	2100:Post-Infusion Follow-Up Form	Modify	Clarified in Q311 which option to select for PTLD: Indicate whether a new or secondary malignancy, lymphoproliferative disorder, or myeloproliferative disorder has developed. Do not report recurrence, progression, or transformation of the recipient’s primary disease (disease for which the transplant was performed), or relapse of a prior malignancy. New malignancies, lymphoproliferative disorders, or myeloproliferative disorders include but are not limited to: Skin cancers (basal, squamous, melanoma) New leukemia New myelodysplasia Solid tumors PTLD (post-transplant lymphoproliferative disorder) (report as lymphoma or lymphoproliferative disease NHL )
7/19/2023	2450: Post-TED	Add	Blue PTLD info box added to Q56: Post-Transplant Lymphoproliferative Disorder (PTLD): PTLD should be reported as a new malignancy if it was confirmed via a biopsy (treatment not required) or suspected to be PTLD and treated.
7/19/2023	2450: Post-TED	Modify	Clarified in Q56 which option to select for PTLD: Indicate whether a new or secondary malignancy, lymphoproliferative disorder, or myeloproliferative disorder has developed. Do not report recurrence, progression, or transformation of the recipient’s primary disease (disease for which the transplant was performed), or relapse of a prior malignancy. New malignancies, lymphoproliferative disorders, or myeloproliferative disorders include but are not limited to: Skin cancers (basal, squamous, melanoma) New leukemia New myelodysplasia Solid tumors PTLD (post-transplant lymphoproliferative disorder) (report as lymphoma or lymphoproliferative disease NHL )

June 2023

6/28/2023	2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion	Add	The Reporting Prior Cellular Therapy as a Line of Therapy blue information box added to Q194: As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion is no longer required to be reported as a line of therapy on the pre-infusion disease specific form
6/28/2023	2018: LYM Pre-Infusion	Add	The Reporting Prior Cellular Therapy as a Line of Therapy blue information box added to Q216: As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion is no longer required to be reported as a line of therapy on the pre-infusion disease specific form
6/28/2023	2016: PCD Pre-Infusion	Add	The Reporting Prior Cellular Therapy as a Line of Therapy blue information box added to Q181: As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion is no longer required to be reported as a line of therapy on the pre-infusion disease specific form
6/28/2023	2014: Myelodysplastic Syndrome (MDS) Pre-Infusion	Add	The Reporting Prior Cellular Therapy as a Line of Therapy blue information box added to Q143: As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion is no longer required to be reported as a line of therapy on the pre-infusion disease specific form
6/28/2023	2011: ALL Pre-Infusion	Add	The Reporting Prior Cellular Therapy as a Line of Therapy blue information box added to Q49: As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion is no longer required to be reported as a line of therapy on the pre-infusion disease specific form
6/28/2023	2010: AML Pre-Infusion	Add	The Reporting Prior Cellular Therapy as a Line of Therapy blue information box added to Q55: As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion is no longer required to be reported as a line of therapy on the pre-infusion disease specific form

May 2023

5/3/2023	2100:Post-Infusion Follow-Up Form	Add	Not applicable / previously reported blue box added to Q9: Not applicable and Previously reported options: When Not applicable is reported for 100-day reporting period, for all future reporting periods, select Previously reported.
5/3/2023	2100:Post-Infusion Follow-Up Form	Add	Not applicable / previously reported blue box added to Q16: Not applicable and Previously reported options: When Not applicable is reported for 100-day reporting period, for all future reporting periods, select Previously reported.
5/3/2023	Key Fields & Signature Lines	Modify	Instructions updated: Accuracy of the Key Fields is essential for ensuring that: Data are being reported for the correct recipient and infusion. Outcomes data accurately reflects appropriate transplant type and product for each transplant center. Data about donors are correctly linked across from for that donor Data are being shared with the correct donor center, cord blood bank, cooperative registry, or other agency. The Key Fields precede the form body and are automatically populated in the FormsNet3 application based on information provided on the CRID Assignment Form 2804. If errors are noted in the key fields, correct Form 2804 and then review it for accuracy. After Form 2804 has been corrected, verify data has been updated on all completed forms. If the data has not been updated automatically, centers will need to reprocess the completed forms to correct the key field data. If errors are noted in key fields for second or subsequent transplants, contact your CRC to make any necessary corrections to the transplant or product type. Transplant and product type will not be automatically populated on product or donor specific forms (Forms 2004, 2005, and 2006) and will need to be manually reported. The Key Fields precede the form body on each form. The key fields are automatically populated when a form (i.e., the “target form”) is opened in edit mode in the FormsNet3 application. The auto-population uses information provided on the CRID Assignment and other forms previously completed (i.e., the “source form”). Centers should review all auto-populated data for accuracy and completeness. If errors are noted in the key fields, the source will need to be updated first. Once the source is accurate, the center will need to reprocess any completed target forms to correct the key field data.
5/3/2023	Key Fields & Signature Lines	Add	Auto-population table and red warning box below table added
5/2/2023	2018: LYM Pre-Infusion	Add	The Follicular Lymphoma Grade Progression blue box was added above Q1 and 83: Follicular Lymphoma Grade Progression: Follicular lymphoma may progress to a more severe grade prior to infusion (i.e., follicular lymphoma grade I to follicular lymphoma grade II); however, progression of the grade of follicular lymphoma should not be reported as a transformation. In cases where the follicular grade progresses, report the initial follicular lymphoma grade as the disease histology at diagnosis and report No, there was not a transformation – the follicular grade after progression will not be captured on the Lymphoma Pre-Infusion (2018) Form.
5/2/2023	2402: Disease Classification	Add	The Follicular Lymphoma Grade Progression blue box added above Q395 and 400: Follicular Lymphoma Grade Progression: Follicular lymphoma may progress to a more severe grade prior to infusion (i.e., follicular lymphoma grade I to follicular lymphoma grade II); however, progression of the grade of follicular lymphoma should not be reported as a transformation. In cases where the follicular grade progresses, report the most severe follicular lymphoma grade (i.e., the follicular grade after progression) as the histology for infusion and report No, there was not a transformation – the initial follicular grade at diagnosis will not be captured on the Disease Classification (2402) Form.
5/1/2023	2402: Disease Classification	Add	Instructions for Q411 added on how to report lines of therapy when there was a Richter’s transformation: A single line of therapy refers to any agents administered during the same time period with the same intent (induction, consolidation, etc.). If a recipient’s disease status changes resulting in a change to treatment, this should be considered a new line of therapy. Additionally, if therapy is changed because a favorable disease response was not achieved, this should be considered a new line of therapy. Do not include surgery when determining the number of lines of therapy. Report the total number of lines of therapy received since the original lymphoma diagnosis up until the start of the preparative regimen / infusion, regardless of if the recipient has received a prior infusion. If there was a transformation (lymphoma transformation or Richter’s transformation), include lines of therapy given to treat the original lymphoma histology or CLL prior to transformation..
5/1/2023	ALL Response Criteria	Modify	Definition of ‘transfusion independent definition clarified for CR and CRi: _Transfusion independent (a minimum of four weeks without platelet or red blood cell transfusion)
5/1/2023	2450: Post-TED	Modify	The Diagnosis of COVID-19 after the start of the preparative regimen blue box above Q49 was updated: Any COVID-19 infections diagnosed after the start of the preparative regimen should be reported in the development of COVID-19 questions on the Post-TED (2450) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated. Effective November 18, 2022, the Respiratory Virus Post-Infusion Data (2149) form for transplants on the TED track will no longer be required. Additionally, an unscheduled Respiratory Virus Post-Infusion (2149) form can not be created for these recipients.
5/1/2023	2100:Post-Infusion Follow-Up Form	Add	Instructions for Q333 clarified: Select the work status that best describes the recipient’s current or most recent employment during this reporting period. If the recipient is Retired, specify their retirement status. If the recipient’s status is anything other than Full time, indicate if the recipient claimed medical disability due to any illness.
5/1/2023	2100:Post-Infusion Follow-Up Form	Add	Instructions for Q328 updated on what to not consider when reporting smoked tobacco cigarettes: The intent of this question is to determine the recipient’s history of smoking cigarettes only. Do not report the use of cigars, pipe tobacco, chewing tobacco, electronic cigarettes, vaping or other drugs. Report Yes if the recipient has smoked tobacco cigarettes since the date of the last report and capture the average number of packs (20 cigarettes per pack) smoked a day, if known. If the recipient has not smoked tobacco cigarettes since the date of the last report, or their smoking history is not known, report No or Unknown.
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	2000: Recipient Baseline	Add	Instructions for Q87 and 95 updated to define peri-transplant period: Report the total dose actually given during the peri-transplant period (before and after infusion). Do not report the prescribed dose or the daily dose. The pharmacy record or Medication Administration Record (MAR) should be used for determining the exact total dose given.
5/1/2023	2000: Recipient Baseline	Add	Instructions above Q86 updated to define peri-transplant period: Drugs may be given during the peri-transplant (before and after infusion) period to prevent transplant-related complications or facilitate engraftment.
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	2031: ID Pre-HCT	Modify	Instructions above Q44 updated: Specify the lymphocyte function assessment performed at the time of diagnosis; if multiple studies were performed prior to the institution of therapy, report the latest values prior to any first treatment for ID. values closest to the diagnosis date.
5/1/2023	2031: ID Pre-HCT	Modify	Instructions above Q36 updated: Specify the antibody response assessment performed at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy (including IVIG), report the latest values prior to any first treatment for ID values closest to the diagnosis date.
5/1/2023	2031: ID Pre-HCT	Modify	Instructions above Q26 updated: Specify the lymphocyte analyses performed at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy, report the latest values prior to any first treatment for ID values closest to the diagnosis date.
5/1/2023	2031: ID Pre-HCT	Modify	Instructions above Q16 updated: Specify the following quantitative immunoglobulins measured at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy, report the latest values prior to any first treatment of the immune deficiency values closest to the diagnosis date.
5/1/2023	2016: PCD Pre-Infusion	Modify	Instructions above Q3 updated: For questions 3-60, report values obtained at diagnosis or prior to the first treatment for the plasma cell disorder for which the transplant was performed. If testing is performed multiple times prior to the start of the first treatment, report the last test before the start of treatment testing performed closest to the diagnosis date.
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).

April 2023

4/21/2023	2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q11.
4/21/2023	2033: WAS Pre-HCT	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q14.
4/21/2023	2031: ID Pre-HCT	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q9.
4/21/2023	2028: Aplastic Anemia Pre-Infusion	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q34.
4/21/2023	2026: Neuroblastoma Pre-Infusion	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q62.
4/21/2023	2019: WM Pre-HCT	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q24.
4/21/2023	2015: JMML Pre-HCT	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q7.
4/21/2023	2014: Myelodysplastic Syndrome (MDS) Pre-Infusion	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q18.
4/21/2023	2402: Disease Classification	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis. These updates were made to the MDS, MPN, and PCD sections.
4/6/2023	4100 Post-CTED	Modify	Increased the length of time required to report resolution of hypogammaglobulinemia from 3 months to 6 months without the need for IVIG infusions. Added a 5th example.

February 2023

2/20/23	4100 Post-CTED	Modify	Updated the applicable response options for non-malignant disease in Table 1: Complete Response, Partial Response, or No Response Normalization of organ function, Partial normalization of organ function, No response, Worsening of organ function
2/16/2023	2100:Post-Infusion Follow-Up Form	Add	Examples of immunosuppression added to Q208
2/16/2023	2118: LYM Post-Infusion Data	Add	Instructions for best response by PET clarified (Q85): Indicate the best response to the line of therapy using the international working group metabolic criteria provided in LYM Response Criteria section of the Forms Instruction Manual. Report “Not assessed” if the recipient’s primary disease is a non-PET avid lymphoma or a PET scan was not performed after the initiation of the line of therapy being reported and prior to the initiation of any new therapy.
2/16/2023	2450: Post-TED	Modify	Examples updated for Q1: Example 8. The recipient had a subsequent non-genetically modified cellular therapy. The recipient has their first transplant on 1/21/15 and a non-genetically modified (e.g. DLI) (excludes DLI) cellular therapy infusion on 2/15/15. There was no lymphodepleting therapy administered. Example 9. The recipient had a subsequent Donor Lymphocyte Infusion (DLI). The recipient has their first transplant on 1/21/2215 and receives a DLI on 2/27/2022. There was no lymphodepleting therapy administered prior to the DLI. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period. Do not complete the follow up form early. Combined follow up will not be applied, a single F2199 is required for each DLI in the reporting period, then HCT reporting continues.
2/16/2023	2100:Post-Infusion Follow-Up Form	Modify	Examples updated for Q1: Example 8. The recipient had a subsequent non-genetically modified cellular therapy. The recipient has their first transplant on 1/21/15 and a non-genetically modified (e.g. DLI) (excludes DLI) cellular therapy infusion on 2/15/15. There was no lymphodepleting therapy administered. Example 9. The recipient had a subsequent Donor Lymphocyte Infusion (DLI). The recipient has their first transplant on 1/21/2215 and receives a DLI on 2/27/2022. There was no lymphodepleting therapy administered prior to the DLI. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period. Do not complete the follow up form early. Combined follow up will not be applied, a single F2199 is required for each DLI in the reporting period, then HCT reporting continues.
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).
2/15/2023	2100:Post-Infusion Follow-Up Form	Add	Clarification added on how to report the mucositis grade: Mucositis requiring therapy: inflammation and ulceration of mucous membranes that line the digestive tract, usually due to chemotherapy and radiotherapy. Specify the grade as 0 (none), I (mild) – oral soreness, erythema, II (moderate) – oral erythema, ulcers, solid diet tolerated, III (severe) – oral ulcers, liquid diet only, or IV (life-threatening – oral ulcers, oral alimentation impossible in question 304. The highest grade in the reporting period should be reported. Do not report mucositis which did not require treatment or intervention during the reporting period.
2/15/2023	4100 Post-CTED	Add	The ‘No Documentation of Contact Date’ red warning box added above Q2: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2900: Recipient Death	Add	The ‘No Documentation of Contact Date’ red warning box added above Q1: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2100:Post-Infusion Follow-Up Form	Add	The ‘No Documentation of Contact Date’ red warning box added above Q1: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2450: Post-TED	Add	The ‘No Documentation of Contact Date’ red warning box added above Q1: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2450: Post-TED	Add	Instruction updated to include a radiologic assessment may be reported for the current disease stats assessment date: If the current disease status is Complete remission, report the date of the most disease specific clinical / hematologic or radiologic assessment performed within approximately 30 days of the contact date. If the current disease status is Not in complete remission – disease detected, report the most recent clinical / hematologic or radiologic assessment performed in the reporting period that detects disease. If the current disease status is Not in complete remission – no disease detected but incomplete evaluation to establish CR, report the last clinical / hematologic (color-red) or radiologic assessment performed in the reporting period.
2/14/2023	2450: Post-TED	Modify	Clarification added on when to use the Previously reported option: The Previously reported option should only be used if the same malignancy has already been reported on a Subsequent Neoplasms (3500) form that was made do on demand. See examples below. If it is unclear whether or not to use of this option, contact CIBMTR Center Support if there are questions. Example 1. A recipient developed a new malignancy at Day +68 and is reported at the time the Day 100 Post-Infusion Follow-up (2450) form is completed. In this scenario, report Yes, the recipient developed a new malignancy, and a Subsequent Neoplasms (3500) form will be completed to report the new malignancy information. For all future reporting periods, select No. Example 2. A recipient developed a new malignancy during the seven-year reporting period and the transplant center decided to create the Subsequent Neoplasms (3500) form as an unscheduled form in FormsNet3SM to report the new malignancy information immediately since a Post-Infusion Follow-Up for seven-year reporting period will not come due. When the eight-year Post-Infusion Follow-Up (2450) form is completed, Previously reported, will be reported since a prior Subsequent Neoplasms (3500) form has already been submitted for the new malignancy. Example 3. A recipient was diagnosed with basal cell skin cancer on the neck in the one-year reporting period and two months later, within the same reporting period, there was a diagnosis of basal cell located on the nose. The lesion on the nose is not considered a metastasis from the neck, but a new discreet lesion. Report Yes, there was a new malignancy on the Post-HCT Follow-Up (2450), and a single Subsequent Neoplasms (3500) form will come due to report one of the basal cell malignancies. Create a second Subsequent Neoplasms (3500) form to report the other basal cell malignancy as these are discreet episodes. If the new malignancy, lymphoproliferative disorder, or myeloproliferative disorder was reported in a prior reporting period, select Previously reported.
2/8/23	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated the text in the blue box below question 121: Serologic tests should be completed during the pre-HCT work-up phase, or approximately one month prior to the start of the preparative regimen. If a recipient tests positive for Hepatitis B core antibody (Anti HBc), Hepatitis B surface antigen (HBsAg), Hepatitis B NAAT, Hepatitis C antibody (Anti HCV), and/or Hepatitis C NAAT serologic tests, also complete the HEP Form (Form 2047). If a recipient tests positive for HIV antibody or HIV NAT serologic tests, also complete the HIV Form (Form 2048).
2/7/2023	4100 Post-CTED	Modify	Added CarvyktiTM to the red warning box below question 180: This question will enable only if the commercially available product Kymriah®, BreyanziTM, Abecma®, or CarvyktiTM is selected in question 1 and can only be completed on the 100 day and 6 month follow-up forms.
2/3/2023	4100 Post-CTED	Modify	Clarified what should not be reported as CRS therapy, highlighting the follow text in a blue box: Supportive care treatments should not be reported as treatment for CRS. Examples of what not to report as other therapy include, but are not limited to, acetaminophen (Tylenol®) albumin, antibiotics, IV fluids, or any brand name or specific corticosteroids administered.

January 2023

1/27/2023	2450: Post-TED	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q38: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did chronic GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed chronic GVHD in the last reporting period of the previous infusion and chronic GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, chronic GVHD persisted since the date of last report.
1/27/2023	2450: Post-TED	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q19: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did acute GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed acute GVHD in the last reporting period of the previous infusion and acute GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, acute GVHD persisted since the date of last report.
1/27/2023	2100:Post-Infusion Follow-Up Form	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q136: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did chronic GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed chronic GVHD in the last reporting period of the previous infusion and chronic GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, chronic GVHD persisted since the date of last report.
1/27/2023	2100:Post-Infusion Follow-Up Form	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q96: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did acute GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed acute GVHD in the last reporting period of the previous infusion and acute GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, acute GVHD persisted since the date of last report.

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