2015 Manual Updates

December 2015
September 2015
August 2015
July 2015
June 2015
May 2015

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December 2015

Date	Manual Section	Add/Remove/Modify	Description
12/9/15	2400: Pre-TED	Modify	Edited the following text in question 62: Stem cells do not typically circulate in the bloodstream. Therefore, in order to increase the quantity of cells for collection, an agent is frequently given to the allogeneic donor or autologous recipient. The purpose of the agent is to move the stem cells from the bone marrow into the peripheral blood. This practice is often referred to as mobilization or priming. Indicate if the donor received plerixafor at any time prior to the preparative regimen. start of stem cell collection.
12/7/15	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify/Add	Edited the text regarding manupulation of products in questions 73-95: Steps in Manipulation If the manipulation consists of several steps, individual steps do not need to be reported as separate manipulations. For example, washing that is part of CD34+ expansion selection does not need to be reported as a separate manipulation. Similarly, T-cell depletion that is part of expansion does not need to be reported. If dilution is performed as part of washing, dilution does not need to be reported. In the cases above, if T-cell depletion and/or washing are done as stand-alone manipulations, they should be reported.
12/7/15	2400: Pre-TED	Modify	Added MPN to the following text in the MDS/MPN Disease specific section: If the recipient is being transplanted for AML that has transformed from MDS/ MPN , the primary disease for HCT must be reported as AML. Disease Classification questions must be completed for both AML and MDS/ MPN .
12/3/15	Appendix Z: Primary Disease and Disease Inserts Due	Modify	Updated Appendix Z Severe Aplastic Anemia table to read that dykeratosis congenita does not require a disease insert.
12/3/15	2400: Pre-TED	Modify	Updated question 420 to refer to all tyrosine kinase inhibitors: There is currently an issue on this form. Question 420 should say “e.g. imatinib mesylate.” Report any tyrosine kinase inhibitors, rather than just imatinib mesylate. Report if the recipient received any tyrosine kinase inhibitors (TKI). Examples of TKIs include Imatinib mesylate (Gleevec, Glivec, STI-571, or CGP57148B), dasitinib (Sprycel), and nilotonib. Indicate “yes” or “no.”
12/3/15	2400: Pre-TED	Add	Added the following text to question 158: Based on the CIBMTR operational guidelines below, report if the regimen was myeloablative, reduced intensity, or non-myeloablative. The determination of whether the intent of the regimen was reduced intensity or non-myeloablative should be based either on the protocol at your center or the opinion of the physician overseeing the care of the recipient at your center. However, if there’s a protocol utilized at your center that doesn’t fall within CIBMTR operational guidelines for regimen intensity, you may report the regimen intensity based on the protocol intent.
12/3/15	2450: Post-TED	Modify	Updated description of DLI indication reporting in Questions 118-119: From the list provided, indicate the reason the cells were infused. If there was more than one reason for the DCI, check all applicable indications. If the recipient received multiple DCIs for more than one indication, report the DCI and the new indication in the second DCI section. If multiple DCIs were given within the 10-week period, check all applicable indications.
12/3/15	2010: AML Pre-HCT	Modify	Updated text in question 12: If the patient is suspected to have had a preceding hematologic disorder, but it was not definitively documented or diagnosed, indicate “suspected” and continue with question 16. 14.
12/3/15	2400: Pre-TED	Add	Added the following italic text to questions 366-401: If question 365 indicates that abnormalities were identified, each of questions 366-400 must be answered as “yes” or “no.” Do not leave any response blank. Indicate “yes” for each cytogenetic abnormality identified at any time prior to the start of the preparative regimen. Indicate “no” for all options not identified by cytogenetic assessment at any time prior to the start of the preparative regimen. For cases where AML has transformed from MDS, only report “yes” for cytogenetic abnormalities identified on or after the date of diagnosis for AML. If one or more abnormalities are best classified as “other abnormality,” specify in question 401.
12/3/15	2800: Log of Appended Documents	Modify	Changed email link on subject topic to cibmtrrecipientforms@nmdp.org.
12/3/15	2005: Confirmation of HLA Typing	Add	Added the following text to question 4: Indicate if the maternal HLA typing is available and continue with question 7; if yes, also complete Form 2005 reporting maternal HLA typing.The form will not come due on its own, so must be added by the data manager.

September 2015

Date	Manual Section	Add/Remove/Modify	Description
9/27/15	2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT	Remove	Removed information box in Engraftment Syndrome [ 2100 ] [ 2200 ] Section: If this was an autologous or syngeneic HCT, continue with the Infection section at question 201.
9/27/15	Multiple Myeloma Response Criteria	Add	Added a footnote: Immunofixation (IFE) and immunoelectrophoresis (IEP) are essentially measuring the same thing and either may be used to determine CR. Electrophoresis (SPEP and UPEP) are, however, different assessments.
9/27/15	MDS/MPN Response Criteria	Modify	Added language to NR/SD criteria: Does not meet the criteria for at least HI, but no evidence of disease progression to AML.
9/27/15	MDS/MPN Response Criteria	Add	Added MPN criteria
9/27/15	2400: Pre-TED 2014: MDS/MPN Pre-HCT	Modify	Modified MDS transformation table [ 2400 ] [ 2014 ] to include RA, 5q- syndrome, MDS-U, and chronic eosinophilia transformations
9/27/15	2400: Pre-TED	Modify	Modified myeloablative, reduced intensity, and non-myeloablative regimens table for thiopeta. Thiotepa ≥ (greater than or equal to) 10 mg/kg is myeloablative, and thiotepa < (less than) 10 mg/kg is non-myeloablative.
9/27/15	2450: Pre-TED	Modify	Added language to question 65: Cause of death is considered the main disease, complication, or injury that leads to death. Do not report the mode of death (e.g., cardiopulmonary arrest). Only one primary cause of death may be specified; however, under “HSCT-related causes,” multiple contributing causes may be listed if relevant.
9/27/15	2450: Pre-TED	Remove	Removed the following phrase from “Subsequent Transplant” for clarification purposes. This does not change the intention of the question; if a recipient receives an autologous rescue, new forms should not come due: However, if the recipient receives an autologous HCT as a result of a poor graft or graft failure, the TED form sequence will not start over again. Generally this type of infusion (autologous rescue) is used to treat the recipient’s poor graft response, rather than to treat the recipient’s disease, and is therefore not considered a subsequent HCT.
9/14/15	2028/2128: Aplastic Anemia	Modify	Updated questions number is 2028 and 2128 Aplastic Anemia Pre- and Post-HCT
9/11/15	2033/2133: Wiskott Aldrich Syndrome	Add	Published new manual for 2033 & 2131 WAS Pre- and Post-HCT.

August 2015

Date	Manual Section	Add/Remove/Modify	Description
8/28/15	2031/2131: Immune Deficiencies	Add	Published new manual for 2031 & 2131 Pre- and Post-HCT Immune Deficiencies Data
8/28/15	2047/2147: Hepatitis Serology	Add	Published new manual for 2047 & 2147 Hepatitis Serology Pre- and Post-HCT Data.
8/3/15	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Added additional product analysis reporting instructions to question 158: To assist centers in reporting product analysis timepoints, the CIBMTR has developed guidelines specific to the product type being reported. … This may be different than the date testing for cell counts or cell viability was performed. [see text for full detail]
8/3/15	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Remove	Removed the following information bubble in question 158: This instruction is under review. If the product is thawed, but not retested prior to infusion, you can report the values prior to cryopreservation as “at infusion.” If a viability assessment is completed, ensure that it is reported accurately for the at infusion time point.

July 2015

Date	Manual Section	Add/Remove/Modify	Description
7/24/15	Appendix M: Reporting Comorbities	Add	Appendix M has been revised and combined with the former appendix U. Appendix U has been retired.
7/24/15	Appendix O: How to Distinguish Infusion Types	Modify	A new revision of Appendix O has been published.

June 2015

Date	Manual Section	Add/Remove/Modify	Description
6/26/15	2450: Post-TED 2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT 2300: Greater Than Two Years Post-HCT	Modify	Updated/Added language to warnings in Chimerism Studies [2100 & 2200 ], Engraftment Syndrome [2100 & 2200 ], and GVHD [2450 ] [Acute: 2100 , 2200 , & 2300 and Chronic: 2100 , 2200 , & 2300 ] sections that state autologous and sygeneic HCTs should skip the applicable sections.
6/26/15	2400: Pre-TED MDS/MPN Response Criteria 2014: MDS/MPN Pre-HCT 2114: MDS/MPN Post-HCT 2015: JMML Pre-HCT	Modify	Edited Progression to AML text in Questions 525 [2400], MDS/MPN Response Criteria, 121 & 123 [2014], 30 [2114], and 63 [2015] to include the following concept: ≥ 20% blasts in the blood or bone marrow
6/26/15	2000: Recipient Baseline	Add	Added the following explanatory text to questions 256-263: Report the recipient’s source of health insurance as of the date of HCT. If the recipient carries more than one source, select “yes” for all that apply. For each option, select “yes” or “no” and do not leave any options blank. U.S.-based, government-sponsored health insurance should be reported in question(s) 256 and/or 257. Non-U.S.-based, government-sponsored health insurance (such as the National Health Service in the United Kingdom) should be reported in question 258. Insurance purchased through an U.S. Affordable Care Act Government Exchange should report this in questions 262-263. If the recipient has a health insurance that is not listed, select “yes” for “other” and specify the health insurance in question 263.
6/26/15	AML Response Criteria	Add	Added the following text to AML CR: Alternative post-transplant CR criteria are accepted in the setting of pediatric AML when the center does not routinely perform bone marrow biopsies post-transplant and the patient was in CR pre-transplant. These criteria are not used for pre-transplant AML disease status. The criteria are as follows: Complete donor chimerism (≥ 95% donor chimerism without recipient cells detected) No extramedullary disease (e.g., CNS, soft tissue disease) Neutrophils ≥ 1,000/µL Platelets ≥ 100,000/µL Transfusion independent
6/12/15	2118: LYM Post-HCT	Add	Added instruction for METHOD and DATE reporting in the Q55-65: Disease Status at the Time of Evaluation for this Reporting Period section. See text for full detail.
6/12/15	2116: PCD Post-HCT	Add	Added instruction for METHOD and DATE reporting in the Q102-136: Disease Status at the Time of Evaluation for this Reporting Period section just prior to question 126. See text for full detail.
6/12/15	2111: ALL Post-HCT	Add	Added instruction for METHOD and DATE reporting in the Q73-96: Disease Status at the Time of Evaluation for This Reporting Period section. See text for full detail.
6/12/15	2110: AML Post-HCT	Add	Added instruction for METHOD and DATE reporting in the Q186-107: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen section. See text for full detail.
6/12/15	Manual-wide	Modify	Language relating to the Lost-to-Follow-Up (2802) has been removed.
6/12/15	2450: Pre-TED	Add	Added explanatory text to question 106: The date reported should be that of the most disease-specific assessment within a reasonable timeframe of the date of contact (approximately 30 days). Indicate the date the sample was collected for examination for pathological and laboratory evaluations; enter the date the imaging took place for radiographic assessments, or the date of physical examination.
6/12/15	2100: 100 Days Post-HCT	Modify	Modified the informational text prior to question 110: ATG given before Day 0 as GVHD prophylaxis should be reported in the preparative regimen section on the Baseline Form (questions 107-111) and on the Pre-TED form (questions 168-172). Report ATG given after Day 0 as GVHD prophylaxis in the acute GVHD prophylaxis section on the 100 Day Post-HCT Data Form (questions 111-113) and on the Pre-TED form (questions 317-319). Please note, ATG given pre and post transplant for GVHD prophylaxis would be reported in both the preparative regimen and GVHD prophylaxis sections of the Pre-TED form. For ATG, Campath, and Cyclophosphamide: If these agents are given for GVHD prophylaxis both prior to and after Day 0, they must be reported in separate sections of the Pre-TED form, and Recipient Baseline Forms. Report doses given prior to Day 0 in the preparative regimen section of the Pre-TED (questions 168-315) and Recipient Baseline (107-242). If given after Day 0 as planned GVHD prophylaxis, report in the GVHD prophylaxis section of the Pre-TED (questions 316-341) and below.
6/12/15	2400: Pre-TED	Modify	Modified the informational text in question 168 and before question 316: ATG or alemtuzumab (Campath) given for GVHD prophylaxis planned prior to Day 0 should be reported in the preparative regimen section of the Pre-TED. If ATG, alemtuzumab, or cyclophosphamide is planned after Day 0, it should be reported in the GVHD prophylaxis section (questions 316-341). For ATG, Campath, and Cyclophosphamide: If these agents are given for GVHD prophylaxis both prior to and after Day 0, they must be reported in separate sections of the Pre-TED form. Report doses given prior to Day 0 in the preparative regimen section of the Pre-TED (questions 168-315). If given after Day 0 as GVHD prophylaxis, report in the GVHD prophylaxis section of the Pre-TED (questions 316-341).
6/12/15	2000: Recipient Baseline	Modify	Modified the informational text in question 105: ATG or alemtuzumab (Campath) given for GVHD prophylaxis prior to Day 0 should be reported in the preparative regimen section of the Baseline Form. If ATG, alemtuzumab, or cyclophosphamide is given after Day 0 for GVHD prophylaxis, it should be reported in the acute GVHD prophylaxis section on the 100 Day Post-HCT Data form. For ATG, Campath, and Cyclophosphamide: If these agents are given for GVHD prophylaxis both prior to and after Day 0, they must be reported in separate sections of the Comprehensive Report Forms. Report doses given prior to Day 0 in the preparative regimen section of the Baseline Form (questions 107-242). If given after Day 0 as GVHD prophylaxis, report in the GVHD prophylaxis section of the 100 Day Post-HCT Data (questions 111-139).
6/12/15	2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT 2300: Greater Than Two Years Post-HCT	Add	Added text to questions 151 [2100], 92 [2200], and 22 [2300]: Indicate the maximum grade of acute GVHD present during this reporting period [including acute GVHD that persists from a previous HCT or donor cellular infusion (DCI)]. If acute GVHD was present, but the maximum grade was not documented nor is it able to be determined from the grading and staging table, leave the maximum overall grade blank and override the error as “Unknown.” Example 1: A recipient developed stage 2 skin involvement and elevated liver function tests (LFTs) attributed to acute GVHD; however, there was no total bilirubin manifestation. In this case, overall maximum grade I acute GVHD should be reported since the staging/grading can be determined using Table 4 [2100, 2200] or 1 [2300]. Example 2: A recipient developed acute liver GVHD with elevated LFTs with no total bilirubin manifestation. The progress notes indicate stage 1 (grade II overall) acute GVHD of the liver. In this case, the clinical manifestations do not fit the criteria used in Table 1; “present, grade unknown” would be the best option to report.
6/12/15	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Added the following text to question 96: If antibodies were used during product manipulation, select “yes” and continue with question 97. However, it is not necessary to report antibody use as part of CD34+ enrichment using the CliniMacs, Isolex, or Miltenyi devices. If antibodies were not used, select “no” and continue with question 109.
6/5/15	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify	Updated daylight savings time reference webpage to http://www.timeanddate.com/time/dst/
6/5/15	2400: Pre-TED	Remove	Removed the following words from the comorbidities section in question 97: Hepatic (mild): Chronic hepatitis, bilirubin > upper limit of normal to 1.5x upper limit of normal, or AST/ALT > upper limit of normal to 2.5x upper limit of normal at the time of transplant, or any history of hepatitis B or hepatitis C infection. See note in question 96.
6/5/15	2400: Pre-TED	Add	Added the following warning box to question 6: There is an exception to this guidance. Do not report a 10-CBA recipient’s participation using this question; select “no” for question 6 if the patient is enrolled in 10-CBA.
6/5/15	2400: Pre-TED	Modify	Modified the explanation for question 451: If more than one “other molecular marker” is identified, add an additional instance in the FormsNet application for questions 453-454. … Assessments for other molecular markers known or believed to be associated with ALLmay be performed. If these studies are performed, indicate “yes” “positive” or “negative” and specify the marker in question 454. If another molecular marker was not performed, select “not done.”
6/5/15	2400: Pre-TED	Modify	Modified the explanation for question 403: Add an additional instance in the FormsNet application for questions 410-411 if more than one “other molecular marker” is identified. … Assessments for other molecular markers known or believed to be associated with AML may be performed. If these studies are performed, indicate “yes” “positive” or “negative” and specify the marker in question 411. If another molecular marker was not performed, select “not done.”
6/5/15	MDS/MPN Response Criteria	Modify	Changed the following text in HI-P: For pre- transplant treatment platelet count of > 20 ×109, platelet absolute increase of ≥ 30 ×109 For pre- transplant treatment platelet count of < 20 ×109, platelet absolute increase of ≥ 20 ×109 and ≥ 100% increase from pre-treatment level
6/5/15	2450: Post-TED 2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT 2300: Greater Than Two Years Post-HCT	Add	Added pediatric acute GVHD Gut guidelines to questions 15 [2450], 151 [2100], 92 [2200], and 22 [2300]. See table for details.
6/5/15	2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT	Modify	Modified text of questions 291-295 [2100] and 231-235 [2200]: Organism: From the table “Codes for Commonly Reported Organisms,” drop down menu, select the code corresponding to the identified or suspected organism … … Site: From the table “Codes for Common Sites of Infection,” drop down menu, select the code corresponding to the site of the infection…
6/5/15	2400: Pre-TED	Modify	Modified the explanation for question 451: If more than one “other molecular marker” is identified, add an additional instance in the FormsNet application for questions 453-454. … Assessments for other molecular markers known or believed to be associated with ALLmay be performed. If these studies are performed, indicate “yes” “positive” or “negative” and specify the marker in question 454. If another molecular marker was not performed, select “not done.”
6/5/15	2400: Pre-TED	Modify	Modified the explanation for question 403: Add an additional instance in the FormsNet application for questions 410-411 if more than one “other molecular marker” is identified. … Assessments for other molecular markers known or believed to be associated with AML may be performed. If these studies are performed, indicate “yes” “positive” or “negative” and specify the marker in question 411. If another molecular marker was not performed, select “not done.”
6/5/15	2200: Six Months to Two Years Post-HCT 2300: Greater Than Two Years Post-HCT	Add	Added text to questions 83 [2200], 137 [2200], 13 [2300], and 67 [2300]: Do not report the results of a biopsy performed in an earlier reporting period; only report histologic confirmation during the reporting period in which the specimen was collected.

May 2015

Date	Manual Section	Add/Remove/Modify	Description
5/29/15	2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT 2300: Greater Than Two Years Post-HCT	Modify	Modified text in questions 500-506 [2100], 441-447 [2200], and 262-268 [2300] to clarify FormsNet reporting: Report the total number of cells infused and specify the exponent for each cell type. If the cells were cryopreserved, report the totals after processing, but before cryopreservation. If completing the paper version, copy this page to report more thanone infusion. The FormsNet3SM application will allow as many infusion entries as needed for the 10-week period. (In Example 5, there would be 4 entries for the first 10-week period). If multiple cellular infusions were given within the 10-week period, report the cumulative total of all cells infused; submit a log of appended documents showing the product analyses for each individual DCI product.
5/29/15	2016: PCD Pre-HCT 2116: PCD Post-HCT	Modify	Added text for clarification in questions 42 [2016], 249 [2016], 18 [2116], and 114 [2116]: (total in g/dL of monoclonal protein) x (total urine volume) = urinary M-protein/24 hours (0.145 g/dL of monoclonal protein) x (1500 mL total urine) x (1 dL/100 mL) = 2.175 g/24 hours
5/29/15	2116: PCD Post-HCT	Add	Added an informational bubble in questions 30 and 126: Flow cytometry is a technique that can be performed on blood, bone marrow, or tissue preparations where cell surface markers can be quantified on cellular material. Currently the CIBMTR forms do not contain fields to capture flow cytometry data. Since the sensitivity of flow cytometry is similar to that of FISH assays, flow cytometry data should be reported in question 31 [or 127]. An exception to the note above applies to multiple myeloma. If the flow cytometry assessment has < 5% malignant plasma cells, this result should not be reported because the result is not reliable; if no other cytogenetic or FISH assessments were performed, report “no.” However, if the flow cytometry assessment found ≥ 5% malignant plasma cells, this should be reported as evidence of disease.
5/29/15	2119: WM Post-HCT	Modify	Clarified explanatory text for questions 22-23: Indicate if the number of cycles is “known” or “unknown.” If the number of cycles is known, continue with question 23 and specify the number of cycles of chemotherapy administered. If the patient received a single administration or one line of chemotherapy, indicate a single cycle. If the patient received long-term maintenance therapy consisting of a single agent, indicate “known” for question 82; leave question 83 blank and override the error as “not applicable.” Indicate if the number of cycles is “known” or “unknown.” If known, report the number of cycles the recipient received during the reporting period for the line of therapy reported in question 23. If the therapy is not given in cycles or the number of cycles is not known, select “unknown” and continue with question 24. If the number of cycles is unknown, continue with question 24.
5/29/15	2116: PCD Post-HCT	Add	Added text to questions 67-68: Indicate if the number of cycles is “known” or “unknown.” If known, report the number of cycles the recipient received during the reporting period for the line of therapy being reported in question 68. If the therapy is not given in cycles or the number of cycles is not known, select “unknown” and continue with question 69.
5/29/15	2016: PCD Pre-HCT	Modify	Modified the text in question 363 for clarity: Example 1: A 62-year-old man is diagnosed with IgG Kappa multiple myeloma. He receives initial therapy with 6 cycles of bortezomib and lenalidomide/dexamethasone; and achieves a near complete remission (nCR). The values used to determine disease status at transplant are the values obtained at diagnosis. The comparison values used to determine disease status at transplant are the values obtained at diagnosis.
5/29/15	Multiple Myeloma Response Criteria	Add	Added the following text to VGPR: … then a ≥ 90% decrease in the difference between involved and uninvolved free light chain levels is required in place of the M-protein criteria .
5/29/15	2400: Pre-TED 2016: PCD Pre-HCT 2116: PCD Post-HCT	Modify	Modified explanatory text for questions 619 [2400], 229 [2016], 363 [2016], 96 [2116], and 135 [2116]: If the recipient had amyloidosis or POEMS syndrome, but no evidence of myeloma, select “Not Applicable (POEMS or Amyloidosis with no evidence of myeloma)”
5/29/15	2016: PCD Pre-HCT	Modify	Added the following text to the subsequent transplant text: If this is a report of a second or subsequent transplant for a different disease (e.g., patient was previously transplanted for a disease other than Plasma Cell Disorder/Multiple Myeloma), select “no” and begin at question 1.
5/29/15	2000: Recipient Baseline	Modify	Added the following instruction to question 4: If the recipient is White, Southeast Asian, or Pacific Islander, but a more specific Race Detail is not available, report the patient is “Other [White, Southeast Asian, or Pacific Islander respectively].
5/29/15	2804: CIBMTR Research ID Assignment form	Add	Added text to question 14: The National MDS Study: The National MDS Study refers to an NHLBI-sponsored study looking at the natural history of MDS; this is not the same as 10-CMSMDS-1, the HCT for MDS Medicare Study. If the individual’s data are being reported to the National MDS Study, continue with question 17.
5/22/15	2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT 2300: Greater Than Two Years Post-HCT	Modify	Added “Oral Beclomethasone” to the following text in question 161-187 [2100], 102-128 [2200], and 32-58 [2300]: “Systemic” refers to drugs given by mouth, intramuscularly (IM), or intravenously (IV). “Topical” refers to drugs applied to the skin, eye drops, or inhalation therapy. An exception to this guidance would be the drugs budesonide and oral beclomethasone. They are drugs given by mouth for treatment of gut GVHD, but considered a “topical” since they’re not absorbed.
5/22/15	MDS/MPN Response Criteria	Add	Added the following text to CR: In some cases, there may not be a four-week interval between completion of therapy and the pre-transplant disease assessment. In this case, CR should still be reported as the status at transplant since it represents the “best assessment” prior to HCT. This is an exception to the criteria that CR be durable beyond four weeks; the pre-transplant disease status should not be changed based on early relapse or disease assessment post-transplant.
5/16/15	2400: Pre-TED	Modify	Removed the following text from the main page: 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 General Instructions, Autologous Hematopoietic Stem Cell Transplant. and added information about autologous reporting: “Centers are required to complete a Pre-TED Form (F2400) for all autologous transplant recipients, whether or not they agree to have their data used in research. … Pre-TED data will make federally required annual Center Volumes report more complete and better able to inform the public about the types of HCTs occurring in the United States.”
5/16/15	2400: Pre-TED	Modify	Removed the following text from Q159: Use the earliest date from questions 161-167 (radiation) or questions 168-315 (chemotherapy). All dates reported in the preparative regimen section must be equal to or after the date reported for this question. and added information about autologous reporting: “Use the earliest date from questions 163, (radiation), or 170-236,  253-311 (systemic therapy) and 314.  Additional radiation and/or intrathecal chemotherapy start dates may be prior to the date the preparative regimen began.”
5/16/15	2000: Recipient Baseline	Modify	Removed the following text from Q78: Enter the date the preparative regimen began. Use the earliest date from questions 82, (radiation), or 109-176 and 193-241 (systemic therapy). All dates reported in the preparative regimen section must be equal to or after the date reported for this question. and added information about autologous reporting: “​Use the earliest date from questions 82 (radiation), or 109-176 and 193-241 (systemic therapy). Additional radiation and/or intrathecal chemotherapy start dates may be prior to the date the preparative regimen began.”
5/16/15	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Added to “Cultured (ex-vivo expansion)” under questions 73-95: If the product is expanded, also report the expansion protocol under “other” in addition to checking “cultured.”
5/16/15	2004: Infectious Disease Markers	Add	Added the following text to question 20: “Non-U.S. centers should answer this question, regardless of FDA licensure.”
5/12/15	2814: Indication for CRID Assignment	Add	Updated manual for new 2814
5/12/15	2804: CIBMTR Research ID Assignment form	Add	Updated manual for new 2804

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