data management guide - cibmtr.org · 7/2/2020 · transplant essential data form 2400, and the...

Data ManagementGuide1 — Last update: Jul 02, 2020

CIBMTR.org

Table of ContentsWelcome ..................................................................................................................................................... 2

Center Participation ................................................................................................................................... 4TED Centers ........................................................................................................................................... 5CRF Centers ........................................................................................................................................... 6EBMT Centers ........................................................................................................................................ 7RSA SecurID........................................................................................................................................... 8

Fee Schedule .............................................................................................................................................. 9

Public Health Authority and Protected Health Information .................................................................... 12PHI ....................................................................................................................................................... 13

Data Collection and Quality ..................................................................................................................... 15FormsNet3℠......................................................................................................................................... 16

Survival Form Status ....................................................................................................................... 17AGNIS .................................................................................................................................................. 18How Forms Come Due .......................................................................................................................... 19

HCT................................................................................................................................................. 20Forms 2004, 2005, and 2006...................................................................................................... 21

Autologous ............................................................................................................................ 22Autologous Cord Blood Units ................................................................................................ 23NMDP Donor ........................................................................................................................ 24NMDP Cord Blood Unit ......................................................................................................... 25Non-NMDP Donor ................................................................................................................. 26Related – HLA-mismatched / HLA-matched ......................................................................... 27Related – Syngeneic / HLA-Identical Sibling.......................................................................... 28Related – Cord Blood Unit..................................................................................................... 29

Non-NMDP Cord Blood Unit ....................................................................................................... 30Cellular Therapy .............................................................................................................................. 31

Form 2005 – Cellular Therapy .................................................................................................... 32Allogeneic, Unrelated Donor.................................................................................................. 33Allogeneic, Related Donor..................................................................................................... 34

Cellular Therapy (no HCT forms due) ......................................................................................... 35Post-HCT Cellular Therapy......................................................................................................... 36Co-infusion ................................................................................................................................. 37

Additional Forms.............................................................................................................................. 38Marrow Toxic Injury ......................................................................................................................... 39

Correcting Historical Data ..................................................................................................................... 40FormsNet2℠ Paper EC Process...................................................................................................... 41Legacy Error Corrections ................................................................................................................. 43Completing Error Correction Forms.................................................................................................. 45

Continuous Process Improvement (CPI)................................................................................................ 46Center Forms Due Communication Updates 2019 ........................................................................... 49Recipient Forms Due List................................................................................................................. 50Recipient CPI Summary Report ....................................................................................................... 51Compliance...................................................................................................................................... 55CPI Forms ...................................................................................................................................... 57

Consecutive Reporting .......................................................................................................................... 58Primary Disease and Disease Forms Due ............................................................................................. 59

Acute myelogenous leukemia (AML or ANLL) .................................................................................. 60Acute lymphoblastic leukemia (ALL) ................................................................................................ 62Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms.......................................... 63Chronic myelogenous leukemia (CML)............................................................................................. 64Myelodysplastic (MDS) / myeloproliferative (MPN)........................................................................... 65Other Leukemia ............................................................................................................................... 67Hodgkin Lymphoma ......................................................................................................................... 68Non-Hodgkin Lymphoma ................................................................................................................. 69NHL-Waldenstrom ........................................................................................................................... 71Multiple Myeloma/Plasma Cell Disorder (PCD) ................................................................................ 72Solid Tumors ................................................................................................................................... 73Severe Aplastic Anemia ................................................................................................................... 75Inherited abnormalities of erythrocyte differentiation or function....................................................... 76Disorders of the immune system...................................................................................................... 77Inherited abnormalities of platelets .................................................................................................. 78Inherited disorders of metabolism .................................................................................................... 79Histiocytic disorders......................................................................................................................... 80Autoimmune diseases...................................................................................................................... 81

Current Form Revision .......................................................................................................................... 83

Protocols and Consents .......................................................................................................................... 84US Transplant Centers.......................................................................................................................... 85International Centers............................................................................................................................. 87Observational Database........................................................................................................................ 88Research Sample Repository ................................................................................................................ 89

Online Training ......................................................................................................................................... 90

Data Manager Mentors ............................................................................................................................. 91

Acronyms.................................................................................................................................................. 92

Quick Links............................................................................................................................................... 94

Contact Us ................................................................................................................................................ 95

WelcomeCIBMTR Data Management Guide

The Data Management Guide contains information on center participation and data submission to theCIBMTR and serves as a resource for individuals seeking guidance about forms due, data quality, and thefunctions of CIBMTR research data processing.

We invite your feedback on individual sections and your suggestions on topics that you would like to seeincluded. Feel free to contact us by email.

Manual Updates

Sections of the Data Management Guide are frequently updated. The most recent updates to the Guide canbe found below. Go to the section and review the updated content.

Date Topic Section Description

2/14/2020 HCT

Forms 2004,2005, and2006

Updated the Non-NMDP Donor, Related HLA-Mismatched/HLA-Matched, Related Syngeneic/HLA-Identical Sibling, Related Cord BloodUnit, and Unrelated Cord Blood Unit tables with correct questionnumbers referenced within tables. Updates match current revisions offorms released in January 2020.

12/3/19

ContinuousProcessImprovement

Recipient CPISummaryReport

Updated the Recipient CPI Summary Report to reflect changes tointernational reporting requirements and trimester dates.

9/12/19

CorrectingHistoricalData

CompletingErrorCorrectionForms

Updated the instruction for submitting error correction forms. Errorcorrection forms should now be submitted via the ServiceNow portal.

9/9/19

FeeSchedule N/A Updated Fee Schedule for cellular therapy forms to reflect form

groupings.

1/17/19


Forms DueReport,SummaryReport,Compliance,and CPIForms

Updated all CPI sections to reflect the inclusion of Cellular Therapyforms.

12/3/18


CPI Forms Removed the 2500 from the list of forms excluded from CPI as theseforms are currently included in CPI counts.

11/14/18


Forms DueReport,SummaryReport, and

These sections were updated to reflect the most recent forms andreports that are involved in the CPI process.

CIBMTR.org Data Management Guide - 1

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mailto:[email protected]

https://nmdp.service-now.com/csm

CPI Forms

9/6/18

FeeSchedule N/A Updated Fee Schedule (formerly referred to as Reimbursement

Schedule) to reflect current rates

2/28/18

DataCollectionand Quality

Current FormRevision

Spring release information; New forms; Forms in revision; volunteersneeded; new email

2/08/18



Changes to each sub-section: Forms Due Report; Summary Report;Non-compliance; and CPI Forms

11/15/18


Current FormRevision Update to form revision schedule

For more detailed instructions on completing CIBMTR forms, access the Forms Instruction Manual.

Last modified: Feb 14, 2020


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https://www.cibmtr.org/manuals/fim

Center ParticipationCIBMTR offers two levels of participation:

• Transplant Essential Data (TED) center• Comprehensive Report Form (CRF) center

The type of data collection forms that a transplant center submits to the CIBMTR is based on the center’slevel of participation. A transplant center may participate as either a Transplant Essential Data (TED only)center, or a Comprehensive Report Form (CRF) center. Participation can vary depending on transplant type(allogeneic vs. autologous), and this designation is agreed upon by the Medical Director of the transplantcenter and the CIBMTR. NMDP centers may be required to complete CRFs for their allogeneic, unrelatedtransplants.

Data from the TED and CRF series will be used for evaluation of the Stem Cell Therapeutic OutcomesDatabase (SCTOD) program operations, including federally required research such as analyses of center-specific outcomes and evaluation of optimal registry and cord blood bank size. Data from theComprehensive Report Forms (CRF) will typically be included in research studies, though TED-level datamay occasionally be used. When appropriate, CIBMTR will share data from these forms with anotherregistry, such as the National Cord Blood Inventory bank.

Each center designates its preferred reporting status, and based on this, CIBMTR uses a selectionalgorithm that assigns transplant recipients to the appropriate data reporting track based on variables suchas consent, type of transplant, age of recipient, disease, etc. Periodically, the algorithm is reviewed toassess the burden of data submission for participating transplant centers.

Last modified: Jun 26, 2017


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TED CentersTransplant Essential Data (TED) Center

A transplant center designated as TED level is required to submit the Transplant Essential Data (TED)forms. All allogeneic HCTs require a minimum of TED level data submission, even if the recipient declinesconsent to the observational research database. The exception being if the recipient is participating incertain clinical trials (e.g. select BMT CTN trials, RCI BMT, etc.) that required submission of CRF level data.In these cases, consent is covered under the study protocol and that criteria will be used to select whichreporting track will be required.



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CRF CentersComprehensive Report Form (CRF) Center

A transplant center designated as CRF level will submit either Transplant Essential Data (TED) forms orComprehensive Report Forms (CRF). The type of follow-up forms a CRF center uses for a specific recipientis determined by the CIBMTR’s selection algorithm. If the recipient does not consent to participate inCIBMTR observational research, then HCT follow-up data must be submitted on the Post-TED forms forallogeneic recipients. Recipients participating in certain clinical trials may be required to submit CRF leveldata, even if the recipient declines consent to the observational database.

Last modified: May 02, 2018


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EBMT CentersEuropean Society for Blood and Marrow Transplantation (EBMT) Centers

EBMT centers have a different process for reporting data to CIBMTR than U.S. centers, and otherinternational centers. Prior to the implementation of FormsNet in December 2007, EBMT centerselectronically forwarded MED‐A data (comparable to TED‐form data) to CIBMTR from centers that hadgiven their permission. When the FormsNet application was implemented, CIBMTR was not able to receiveelectronic transfer of MED‐A data. As a result, MED‐A level data appear on the CIBMTR Forms Due reportas TED forms being “overdue,” even though a center may have submitted these data to EBMT. Those“overdue” forms listed on the report can be ignored. CIBMTR is working with EBMT to electronically transfer“overdue” data.

At CIBMTR, we understand that the current Forms Due Report is not optimal for EBMT centers, andapologize for this inconvenience. We appreciate your patience as we work to complete implementation ofelectronic data transmission between the EBMT and CIBMTR databases. Feel free to contact your CIBMTRCenter CRC if you have additional questions about the Forms Due reports.

CIBMTR is currently working with EBMT on electronic data transfer. The EBMT can now successfully submitthe following forms to the CIBMTR via AGNIS:• Form 2400 Pre‐TED• Form 2450 Post‐TED• Form 2804 CIBMTR Research ID (CRID) Assignment• Form 2814 Indication for CRID Assignment• Form 2006 Hematopoietic Stem Cell Transplant (HCT) Infusion

All other forms are CRFs, and should be submitted directly to CIBMTR in FormsNet3. Examples of CRFforms include:• Form 2000 Baseline• Form 2100 Post-HCT Data• Disease specific inserts• Form 2900 Recipient Death DataSee: Data Collection Forms

At this time, there is not an “electronic pathway” for CRF form data to be transferred from EBMT to CIBMTR.Therefore, CIBMTR plans to continue to request follow‐up wherever possible for patients on the CRF track.Follow‐up for these patients can be submitted to CIBMTR via FormsNet. These patients also appear onForms Due reports, and CIBMTR would like centers to respond to requests for follow‐up CRF data.



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https://www.cibmtr.org/DataManagement/DataCollectionForms/Pages/index.aspx

RSA SecurID

Soft TokenOur international centers are now moving to a smartphone app-based “soft” token for logging on atconnect.nmdp.org. Setting up the soft token is slightly different than setting the PIN for the SecurID token,but not difficult. Instructions are provided and support is available from the Be The Match Service Desk at(763)406-3411. CIBMTR staff are also available to assist. The RSA app works like the SecurID, but the PINis entered into the user’s smartphone. An 8-character code is generated. That code is used to log into thesystem. Logging into FormsNet3 remains the same.

LDAP Password ResetA convenient new feature has been added to the connect.nmdp.org page – a self-service password resetoption. This eliminates the need to contact the Service Desk for a password. The option is called LDAPPassword Reset and it can be found on the connect.nmdp.org page after logging in with the RSA SecurIDor app-based soft token. A link to set a password is sent to the email address that we have listed in theuser’s account. If there are any questions about the LDAP Password Reset, you can contact the Be TheMatch Service Desk at (800)526-7809 ×3411 or 763-406-3411 (outside of the U.S.)



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https://connect.nmdp.org/

Fee ScheduleFee Schedule for Forms Completion

The CIBMTR pays transplant centers for all completed Comprehensive Report Forms and Cellular TherapyForms. Reporting of TED level data is not compensated, with the exception of the Form 2006 whenrequested for recipients on the TED track. Once a form is designated as “CMP” in the FormsNet application,the transplant center will be paid during the next payout time-point. Effective January 1, 2013,Comprehensive Report Forms will be paid only if completed within one calendar year of the form due date.Forms are paid at the following rate:

Data Transmission Agreement / Master Healthcare Data and Sample SubmissionAgreement Fee Schedule

Form # Description Payment TIN1

Product Insert

Form 2006 HSCT Infusion $25* CIBMTR

* An infusion form (Form 2006) may be paid when requested by CIBMTR for those recipients not on the CRFtrack. No center will be paid twice for the same form.

Comprehensive Report Forms

Form 2000+ Recipient Baseline Form, plus disease specific inserts

$135 CIBMTRForm 2004+ Infectious Disease Markers (related donor only)

Form 2005+ Confirmation of HLA Typing (related donor only)

Form 2006+ HSCT Infusion Form

+ These four forms will be paid as a unit when all required forms are received.

Form 2100 100 Days Post-HSCT Data, plus any required inserts $110 CIBMTR

Form 2100 Six Months to Two Years Post-HSCT Data, plus any required inserts $85 CIBMTR

Form 2100 Yearly Follow-Up for Greater than Two Years Post-HSCT Data, plusany required inserts $65 CIBMTR

Form 2900 Recipient Death Data $15 CIBMTR

Cellular Therapy Essential Data (CTED) Forms

Form 4000* Pre-Cellular Therapy Essential Data Form

$150 CIBMTRForm 4003* Cellular Therapy Product Form

Form 4006* Cellular Therapy Infusion Form

Form 2402* Disease Classification Form


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Form 2005* Confirmation of HLA Typing

* These five forms will be paid as a unit when all required forms are received. Not all cellular therapies require aF2402 or F2005.

Form 4003+ Cellular Therapy Product Form $10 CIBMTR

Form 4006 R1/2+ Cellular Therapy Infusion Form $25 CIBMTR

Form 4006 R3+ Cellular Therapy Infusion Form $15 CIBMTR

+Paid separately when associated with a Pre-TED F2400.

Form 4100 Post Cellular Therapy Essential Data Form $120 CIBMTR

Form 2011 / 2013/ 2018 Disease-Specific Pre-Treatment Insert for ALL, CLL or LYM $80 CIBMTR

Form 2111 / 2113/ 2118 Disease-Specific Post Disease Insert for ALL, CLL or LYM $80 CIBMTR

Form 3500 Subsequent Neoplasms $25 CIBMTR

Form 3501 Pregnancy $25 CIBMTR

Repository Forms

N/A Repository Sample Received – Related Donor Transplant $35 TC

N/A Repository Sample Received – Unrelated Donor Transplant $10 TC

Form F00227 Repository Excuse Code – Related Transplant $10 TC

Form F00227 Repository Excuse Code – Unrelated Transplant $5 TC

1 Payment is made to the Tax Identification Number (TIN) for the TC# or CIBMTR# as provided by theCenter.

Study Forms

For Centers participating in the studies specified below, effective January 20, 2020, Study Forms will bepaid only if completed within one calendar year of the form due date. Forms are paid at the following rate:

Study Name Form Number Description Fee

SP16-02:Veno-Occlusive Disease (“VOD”)Data Registry

Form 2553Veno-Occlusive Disease (VOD) / SinusoidalObstruction Syndrome (SOS) SupplementalData Form

$300 /form

SC16-06:Safety of Allo HCT in classical HLpatients treated with Nivolumab

Forms are inRAVE; no form

ID

One Time Start Up Fee $1000

Supplemental Data Form $200 /form

KFG Study Form 2503 KGF Study Supplement $100 /form


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Form 2504 KGF Study Long-Term Follow Up $100 /form

SC15-04:Plerixafor Prospective RegistryStudy

Form 2565 Mozobil Supplemental Data Form $500 /form

Center Survey $100

SC17-03:Use of Tepadina as part of prepregimen followed by HCT

Form 2540 Tepadina Supplemental Data Form $100 /form

SC17-02:Rate and Characterization of VODin Patients who received Mylotargpre-HCT

No form Supplemental Data (collected via an Excelfile $150

SC17-10:PASS study of Inotuzumab tocharacterize post-HCT for B-CellALL

Form 2541 Inotuzumab Supplemental Data Form $100 /form

Last modified: Jan 14, 2020


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Public Health Authority and Protected HealthInformationPublic Health Authority (PHA) Status

CIBMTR meets the U.S. Department of Health & Human Services HIPAA Privacy Rule’s definition of apublic health authority (PHA) and is authorized by law to collect the information necessary to fulfill thelegislated mandate to collect data needed to assess outcomes of hematopoietic cell therapy. It is thereforenot a “covered entity” under HIPAA. Additionally, transplant centers that fit the definition of covered entitiesmay disclose certain individually identifiable health information to the CIBMTR under 45 CFR 164.512(HIPAA Privacy Rule). This allows for the disclosure of an individual’s protected health information withoutthe individual’s written consent or authorization when such a disclosure is made to a PHA that is authorizedby law to collect information for the purpose of preventing or controlling disease, injury, or disability.

(See: The National Institutes of Health’s Protecting Personal Health Information in Research: Understandingthe HIPAA Privacy Rule. Click here)



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https://privacyruleandresearch.nih.gov/pr_02.asp

PHIProtected Health Information (PHI) and the CIBMTR Research ID (CRID)

In order to create a universal unique ID system, the CIBMTR collects protected health information (PHI),including but not limited to identifiers such as name, social security number (SSN), mother’s maiden nameand birth information. This decision was made after careful consideration by a combination of CIBMTR staff,an external Data Advisory Group and representatives of the Health Resources and Services Administration(HRSA). Upon notification of a patient’s first HCT or cellular therapy, the CIBMTR will request the PHIneeded to create a unique CIBMTR Research ID (CRID). A CRID must be assigned using the CIBMTRResearch ID (CRID) Assignment Form (Form 2804). The CRID is a lifelong ID used across the entire C.W.Bill Young Cell Transplantation Program. Direct identifying information collected to establish the CRID willnot be disclosed to investigators for research purposes.

The use of PHI to uniquely identify recipients who are registered with CIBMTR is needed for severalreasons. First, CIBMTR is required by HRSA to develop a system to uniquely identify recipients for center-specific outcomes reporting. The CRID will avoid duplication of recipient records across transplant andcellular therapy programs, particularly when situations exist where sequential HCTs occur at differentinstitutions. The CRID will facilitate knowledge of previous autologous HCTs that may not be reported by acenter performing an allogeneic HCT, and therefore adjusting the expected outcome accordingly for center-specific outcome reporting. Data used to generate a CRID may be used to increase the value of the StemCell Therapeutic Outcomes Database (SCTOD) by acquiring matching data from other Federal governmentdatabases for government reports or research. Second, generation of a CRID is essential to determiningthat all allogeneic HCT recipients in the United States are reported to the SCTOD. In the event of a statelaw or IRB policy that supersedes federal statute, centers may opt out of providing some of these data.

The items listed below highlight the important security concerns that have been addressed with regard tothe collection of the PHI.

•CIBMTR and NMDP are designated Public Health Authorities in the capacity of collecting and using datafor the SCTOD and addressing HIPAA privacy regulations.

•The electronic system that collects the PHI is called FormsNet3. The server holding the direct identifiers issecure and is separate from the outcomes database. Access to these data is highly restricted within theCIBMTR. The electronic systems used for acquisition and generation of CRID numbers have undergonerigorous certification and authorization from HRSA’s Office of Information Technology and comply with allUnited States federal regulations (21 CFR Part 11) relevant to security of electronic data in federaldatabases.

•Electronic transmission of the PHI from transplant centers using FormsNet3 is protected by doubleauthentication entry requirements (login/password and SecurIDTM card) for all system users who enter thedata. Electronic transmission is protected by SSL technology.


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•The PHI used to create the CRID will not appear on any subsequent forms or correspondence. Centerswishing to confirm a CRID will be able to re-enter data into one-way look-up tables, however PHI will not bedisplayed by the system. This security measure will prevent inappropriate revealing of PHI to unauthorizedindividuals.

For more information regarding the Form 2804, see the Forms Instruction Manual, or access the eLearninghere.



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https://www.cibmtr.org/manuals/fim/1/en/topic/2804-cibmtr-research-id-assignment-form?q=2804

http://nmdp.learnercentral.com/ContentRegistration.aspx?DocumentID=5a1b1fb6-0598-4006-8a49-71ab81c726ef&Cust=34083&ReturnUrl=/p/3408339256

http://nmdp.learnercentral.com/ContentRegistration.aspx?DocumentID=5a1b1fb6-0598-4006-8a49-71ab81c726ef&Cust=34083&ReturnUrl=/p/3408339256

Data Collection and QualityCIBMTR, in collaboration with the worldwide hematopoietic cell transplantation community, developedappropriately organized forms to capture a standard set of data elements for all transplant recipients. Theseforms are revised as needed to match the evolving science and medical advances in cellular therapyresearch to ensure that the most relevant data are collected.

Form Submission

CIBMTR encourages centers to submit forms electronically through either FormsNet3 or AGNIS. Theseelectronic submission mechanisms allow for immediate validation of data allowing centers to correct orvalidate data prior to submission. When that is not possible, we accept a paper version of the form.

To view any of the forms in their paper format click here.

Last modified: Apr 13, 2017


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https://www.cibmtr.org/DataManagement/DataCollectionForms/Pages/index.aspx

FormsNet3℠℠More than 95% of data collected by the CIBMTR is submitted electronically via FormsNet3℠, acomprehensive electronic data capture system containing greater than 250 forms related to the capturing ofHCT outcomes for donors and recipients.The FormsNet3 application is CIBMTR’s clinical research management system that brings togetherresearchers from around the world to share data and knowledge used to answer questions critical to savinglives.FormsNet3 provides enhanced features and functions, including user friendly site navigation, field levelsaving, auto-population, enabling/disabling of fields, and timely form processing.

How to Use the Application:

FormsNet3 Recipient Application Training may be accessed immediately from here. Or, you can download

the FormsNet3 Training Guide.



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http://nmdp.learnercentral.com/ContentRegistration.aspx?DocumentID=cfbb307e-650a-4ba6-8100-fd748ad38a13&Cust=34083&ReturnUrl=/p/3408360666

https://www.cibmtr.org/DataManagement/TrainingReference/FormsNet/Documents/FN3%20Training%20Guide%20AE.pdf

Survival Form StatusWhen you have a patient that is further out from transplant, you know is alive and all efforts to obtain follow-up data on a patient have failed, you can report the recipient’s latest alive date of contact, thus eliminatingthe need to override multiple questions to get forms to complete status.

This feature is located in the same location as the Lost to Follow-up (LTF) feature. Simply select if you arereporting Survival or LTF, then answer the applicable questions.

Additionally, the feature updates the corresponding disease inserts’ form status to match the 2100 Form,(i.e. you only need to complete Survival or LTF once for the visit instead of on both forms).



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AGNISAGNIS® (A Growable Network Information System) is an open-source messaging system specificallydesigned to exchange hematopoietic cell transplant data using a secure, standards-based system.

Transplant centers can use AGNIS to retrieve and transmit form data, extracted directly from their owninstitution’s database, directly to the FormsNet3℠ application using a secure and authenticated electronicdata transmission system.

AGNIS gives centers an “enter once, use often” data capability by handling all subsequent distribution andsynchronization between databases, including the CIBMTR database.

For information to access AGNIS and training, please see the AGNIS section on the CIBMTR website. Clickhere.



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http://www.cibmtr.org/DataManagement/TrainingReference/AGNIS/Pages/index.aspx

http://www.cibmtr.org/DataManagement/TrainingReference/AGNIS/Pages/index.aspx

How Forms Come DueWhen first registering a patient with the CIBMTR, the center must complete a CIBMTR Research ID (CRID)Assignment (2804) in FormsNet3℠, which generates a unique identifier for the patient. Once a CRID isassigned, the Indication for CRID Assignment Form (2814) must be completed to report the indication.Depending on the indication reported, forms are added to the Forms Due list by FormsNet3, and must thenbe completed by the center.

Indication Forms Due

HCT Pre-TED (Form 2400)Disease Classification (Form 2402)

Cellular therapy (non-HCT) Pre-CTED (Form 4000)

Marrow Toxic InjuryRITN Baseline Form (Form 5000)RITN Contact Form (Form 5001)RITN Follow-Up Form(s) (Form 5002)

Non-cellular therapy (e.g. chemotherapy,immunotherapy, etc.)

No additional data is required at this time. No formsrequired (Stop Here)

If the indication reported is Non-cellular therapy, no additional data is required at this time. For moreinformation, see the Indication for CRID Assignment (2814) Form Instruction Manual, or access theeLearning here.

If the indication reported was HCT, Cellular therapy (non-HCT), or Marrow toxic injury, refer to the sectionsspecific to those indications for more information on CIBMTR forms due.

Indication and Pre-TED Forms

As of May 13, 2015, the CIBMTR requires centers to complete the Pre-TED Forms (Form 2400 and 2402)for all autologous transplant recipients, whether or not they consent to have their data used in research. Therelease of the revised CRID Assignment Form (Form 2804) and new Indication Form (Form 2814) inFormsNet3 on May 12, 2015 supported this change.



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https://www.cibmtr.org/manuals/fim/1/en/topic/2814-indication-for-crid-assignment

http://nmdp.learnercentral.com/ContentRegistration.aspx?DocumentID=c5a02be3-be4e-471c-97fc-b15fc42125d0&Cust=34083&ReturnUrl=/p/3408336463

http://nmdp.learnercentral.com/ContentRegistration.aspx?DocumentID=c5a02be3-be4e-471c-97fc-b15fc42125d0&Cust=34083&ReturnUrl=/p/3408336463

HCTWhen the indication is reported as HCT for the patient’s first event, or an HCT is reported on an HCT orcellular therapy follow-up form, the Pre-TED Forms 2400 and 2402 will be the first to come due. Once thePre-TED forms are complete and the data are processed, the selection algorithm determines if the patientwill follow the CRF or TED track.

If the patient is autologous and did not give consent to submit data to the research database and is notparticipating in a study protocol requiring data to be submitted, no additional forms are required.

Autologous patients that did not give consent to the research database but are participating in specific studyprotocols will be assigned to the CRF track while enrolled in the study.

For all other patient types, follow the appropriate track below:

TED track – Click here to see the Visio flowchart for how forms come due.

CRF track – Click here to see the Visio flowchart for how forms come due.

Last modified: Mar 16, 2020


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https://cdn.manula.com/user/3235/docs/ted.pdf

https://cdn.manula.com/user/3235/docs/crf_v1.pdf

Forms 2004, 2005, and 2006Infectious Disease Markers (Form 2004)Confirmation of HLA Typing (Form 2005)Hematopoietic Stem Cell Transplant (HCT) Infusion (Form 2006)

• If a form 2005 has been completed for the recipient for a prior event date, another will not be madedue.

• If the donor was used for a previous HCT or cellular therapy for the same recipient and 2005s werenot captured for the donor and/or recipient, form(s) will be made due.

• In the case of cellular therapies occurring post-HCT, where the same donor is used from the priorHCT, no form 2005s are required.

• A form 2004 is required for each product type from a single donor.• If you have any questions or think a form has been made due in error, please contact your CIBMTR

CRC.

The following tables display how the 2004, 2005, and 2006 forms come due by donor types for HCTrecipients.



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AutologousForm 2004 Form 2005 Form 2006

For each instance where:Donor type = AutologousCRF track

X (for each product)



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Autologous Cord Blood UnitsForm 2004 Form 2005 Form 2006

For each instance where:Donor type = Autologous cord blood unitCRF track


For each instance where:Donor type = Autologous cord blood unitTED track




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NMDP DonorForm 2004 Form 2005 Form 2006

For each instance where:Donor type = NMDP unrelated donorCRF Track


For each instance where:Donor type = NMDP unrelated donorTED Track




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NMDP Cord Blood UnitForm 2004 Form 2005 Form 2006

For each instance where:Donor type = NMDP unrelated cord blood unitCRF Track


For each instance where:Donor type = NMDP unrelated cord blood unitTED track




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Non-NMDP DonorForm 2004 Form 2005 Form 2006

For each instance where:Donor type = Non-NMDP unrelated donorTED trackQ17= No, Not approached, or Not applicable(consent for Research Sample Repository)Q58 = No

X (donor)X (recipient)

For each instance where:Donor type = Non-NMDP unrelated donorQ17= Yes (consent for Research Sample Repository)TED trackQ58 = No

X (donor) X (donor)X (recipient) X (for each product)

For each instance where:Donor type = Non-NMDP unrelated donorCRF trackQ58 = No




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Related – HLA-mismatched / HLA-matchedForm 2004 Form 2005 Form 2006

For each instance where:Donor type= HLA-matched other relativeor HLA-mismatched relativeQ17 = Yes(yes to consent for Research Sample Repository)TED trackQ58 = No


For each instance where:Donor type = HLA-matched other relativeor HLA-mismatched relativeTED trackQ17= No, Not approached, or Not applicable(consent for Research Sample Repository)Q58 = No


For each instance where:Q52 = HLA-matched other relativeor HLA-mismatched relativeCRF trackQ58 = No




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Related – Syngeneic / HLA-Identical SiblingForm 2004 Form 2005 Form 2006

For each instance where:Donor type = Syngeneic (monozygotic twin)or HLA-identical siblingCRF trackQ58 = No

X (donor) X (recipient) X (for each product)

For each instance where:Donor type = Syngeneic (monozygotic twin)or HLA-identical siblingQ17 = Yes(yes to consent for Research Sample Repository)TED trackQ58 = No

X (donor) X (recipient) X (for each product)

For each instance where:Donor type = Syngeneic (monozygotic twin)or HLA-identical siblingQ17= No, Not approached, or Not applicable(consent for Research Sample Repository)TED trackQ58 = No



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Related – Cord Blood UnitForm 2004 Form 2005 Form 2006

For each instance where:Donor type = Related cord blood unitTED trackQ58 = No


For each instance where:Donor type = Related cord blood unitCRF trackQ58 = No




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Non-NMDP Cord Blood UnitForm 2004 Form 2005 Form 2006

For each instance where:Donor type = Non-NMDP unrelated cord blood unitTED trackQ58 = No


For each instance where:Donor type = Non-NMDP unrelated cord blood unitCRF trackQ58 = No




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Cellular TherapyWhen the indication is reported as Cellular therapy (non-HCT) for the patient’s *first*__ event, or apost-HCT cellular therapy is reported on an HCT follow-up form, the Cellular Therapy Pre-CTED Form 4000will come due. Once completed and the data is processed, FormsNet3℠ will add additional forms based onthe product and donor type.

Click on the appropriate cellular therapy scenario to determine what forms will come due.



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Form 2005 – Cellular Therapy• If a form 2005 has been completed for the recipient for a prior event date, another will not be made

due.• If the donor was used for a previous HCT or cellular therapy for the same recipient and 2005s were

not captured for the donor and/or recipient, form(s) will be made due.• In the case of cellular therapies occurring post-HCT, where the same donor is used from the prior

HCT, no form 2005s are required.• If you have any questions or think a form has been made due in error, please contact your CIBMTR

CRC.

The following tables display how Confirmation of HLA Typing Form 2005 comes due by donor types(Allogeneic, Unrelated or Related) for Cellular Therapy.



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Allogeneic, Unrelated DonorIf the donor is the same donor used for a prior cellular therapy or HCT, and a Form 2005 has already beencompleted for the recipient and/or donor, then no additional Form 2005s are required. If you think that onehas been made due in error, please contact your CIBMTR CRC.

Form 2005

For each instance where:Q32 Specify the cell source = Allogeneic, unrelatedQ34 = No




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Allogeneic, Related DonorIf the donor is the same donor used for a prior cellular therapy or HCT, and a Form 2005 has already beencompleted for the recipient and/or donor, then no additional Form 2005s are required. If you think that onehas been made due in error, please contact your CIBMTR CRC.

Form 2005

For each instance where:Q32 Specify the cell source = Allogeneic, relatedQ33 Specify the related donor type = Syngeneic,or HLA-identical siblingQ34 = No

X (recipient)

For each instance where:Q32 Specify the cell source = Allogeneic, relatedQ33 Specify the related donor type = HLA-matched other relative,or HLA-mismatched relativeQ34 = No




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Cellular Therapy (no HCT forms due)This Visio flowchart shows how forms come due when the indication is Cellular Therapy (no HCT formsdue).



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Post-HCT Cellular TherapyThis Visio flowchart shows how forms come due when the infusion is Post-Transplant Cellular Therapy(e.g. DCI).



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Co-infusionThis Visio flowchart shows how forms come due when there is a co-infusion.



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Additional FormsData reported on the CIBMTR forms may trigger additional forms to come due. Examples of these formsinclude, but are not limited to:• Infection forms (e.g. Fungal Infection Forms 2046/2146)• Study specific forms (e.g. 2500 series)• Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome Supplemental Form 2553

Additionally, there are several forms that are used by the center as needed, and submitted to the CIBMTR.Examples include, but are not limited to:• Delayed / Canceled HCT Form (Form 2008)• Request for Recipient Transfer (Form 2801)

For more information on how to complete these forms, see the Forms Instruction Manual, or contact yourCIBMTR CRC.



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https://www.cibmtr.org/manuals/fim

Marrow Toxic InjuryWhen the indication is reported as marrow toxic injury, the RITN Baseline Form 5000, RITN Contact Form5001, and RITN Follow-Up Forms will come due.

Note: Marrow toxic injury should only be reported as an indication by participating Radiation InjuryTreatment Network centers in the event of a radiation incident.

For more information on RITN, click here, or contact your CIBMTR CRC.

Click here to see the Visio flowchart for how forms come due.



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http://ritn.net/About/

https://www.cibmtr.org/DataManagement/TrainingReference/eLearning/_layouts/15/VisioWebAccess/VisioWebAccess.aspx?id=/DataManagement/TrainingReference/eLearning/Documents/Marrow%20Toxic%20Injury.vsdx&Source=https%3A%2F%2Fwww%2Ecibmtr%2Eorg%2FDataManagement%2FTrainingReference%2FeLearning%2FDocuments%2FForms%2FAllItems%2Easpx%23InplviewHash1244c6d3%2Df3df%2D4d15%2Da2dd%2D6d8c5273827e%3DPaged%253DTRUE%2Dp%5FSortBehavior%253D0%2Dp%5FFileLeafRef%253DManual%252520Updates%252520for%252520Newsletter%2525202%2525207%25252014%252520%2525282%252529%25252epdf%2Dp%5FID%253D5337%2DPageFirstRow%253D91

Correcting Historical DataWith the release of FormsNet3℠, all corrections to Legacy Data (submitted prior to FormsNet2℠) andFormsNet2℠ forms that aren’t FormsNet3℠ editable, need to be sent via Paper Error Corrections.

Data entered into FormsNet3℠ (since 12/4/12) or on FormsNet3℠ editable FormsNet2℠ forms should becorrected in FormsNet3℠.



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FormsNet2℠℠ Paper EC ProcessError corrections for FormsNet2 versions of the forms are available on the Retired Forms page of CIBMTR’swebsite. Please make sure to use the correct version of the form that was completed for all FormsNet2documents. The question number and sometimes entire questions may be different depending on theversion of the form used.

To Find theAppropriateForm

Select thePDFsymbol ofthe formthat needscorrectionfrom thefirst columnof theForms Grid

To Find theForm Version

Look to thebottom ofthe form’spage

To Find theErrorCorrectionForm

From theRetiredFormswebpage,on thesame row,select theform, andthe version,on the farrightcolumn isthe Error

Correction form.

To Find theSequenceNumbers

In the Recipient Forms tab, the Forms Due Grid displays the sequence number for each form.This number is used by data entry to assure corrections are made to the right form.

Note: The CRID Assignment Form 2804 does not have a sequence number, so this field shouldbe left blank on the banner.


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http://www.cibmtr.org/DataManagement/DataCollectionForms/Pages/Retired.aspx



To Find theInfusion Date

The infusion date is located in the ‘Event’ column. Be aware which infusion the form wassubmitted for, if there are more than one for the patient.



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Legacy Error CorrectionsHow to make changes to Legacy Data

“Legacy data” are data submitted to CIBMTR or National Marrow Donor Program® (NMDP)/Be The Matchbefore the FormsNet2℠ application became available on December 3, 2007. If you need to make changesto data that were submitted to the legacy databases, please send an error correction to document thechange.

You only need to send the page that has the information on it that needs to be changed. For all corrections,please indicate “LEGACY ERROR CORRECTION” on the page so we know where to find the data that youare changing.

The procedures to follow are different depending on whether corrections are being made to NMDP/Be TheMatch or CIBMTR forms.

NMDP/Be The Match forms

Blank Error Correction pages for NMDP/Be The Match forms are available on the Retired Forms page ofCIBMTR’s website.

• Follow the instructions on Completing the Error Correction Form• The sequence number from the legacy forms is not available in FormsNet3℠. This may be left blank

and your CRC will add this for you.

IBMTR / ABMTR forms

For IBMTR / ABMTR forms, if you need to change data on a previously submitted old version IBMTR form(002 Core or earlier), please copy the original page of the old form and indicate “LEGACY ERRORCORRECTION” on the top of the page. Please cross out the original answer, and record the correct answerand circle it. Please initial and date your changes and send to your assigned campus. If the original CIBMTRform is not available, you may send an email containing the following information:

• Old IBMTR Team #• Recipient IUBMID #• Date of Birth• Date of HCT that the correction pertains to• Which form is being corrected and the Question Number• A clear explanation of the change that needs to be made

Note: If you submitted NMDP/Be The Match data to both organizations, you do not need to submitcorrections to both campuses. Send the corrections to your assigned CRC. They will ensure that theinformation is changed in the legacy databases and in FormsNet if applicable.


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Completing Error Correction FormsThe banner box needs to be completed for each page.

1. Provide the Sequence Number from the original form2. Provide the CRID, Infusion Date, and Center Number3. Today’s Date – is the date you are completing the EC4. Provide your initials in the ‘Initials’ box to indicate that you are approving the change

You only need to complete the questions on the form where updates to the data are required. It is helpful tohighlight these changes with an arrow or circle, especially if the change is small. Be aware, a change to onequestion may result in other questions needing to be answered or deleted. Only the page(s) with datachanges need to be sent.

Submit the form via the ServiceNow portal.

Last modified: Sep 12, 2019


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Continuous Process Improvement (CPI)The CIBMTR Continuous Process Improvement (CPI) program has been ongoing with US centers since2010, to monitor and track the submission of required data by network transplant centers. In 2019, CIBMTRstarted to roll out CPI with non-US centers.

US Center Requirements:

On a trimester basis (January, May, and September), centers are reviewed and held accountable formeeting CPI standards for Allogeneic Related, Allogeneic Unrelated, Autologous, and Cellular Therapy (CT)infusions. To be compliant with CPI standards, there are three requirements:

1. Having current IRB documents (renewal letters and consents) on file with NMDP2. Meeting the requirements of consecutive reporting of hematopoietic cell transplants (HCT) which

includes centers submitting their complete list, registering CRIDs for any unregistered patients,resolving invalid CRIDs that do not exist in FormsNet3℠ (FN3), and resolving data discrepancies (i.e.mismatches) that were found between center-provided lists and FN3

3. Form completion of at least 90% of the required forms for four product types at each of three timeperiods as well as CT forms (January 1 – April 30th, May 1 – August 31st, September 1 – December31st) as applicable

• Allogeneic Related form completion◦ All three time periods

• Allogeneic Unrelated form completion◦ All three time periods

• Autologous form completion◦ All three time periods

• Cellular Therapy form completion◦ All three time periods

Please see Non-compliance section of the Data Management Guide for details about what happens if acenter fails to meet the CPI standard.

Non-US Center Requirements:

On a trimester basis (November, March, and July), centers are reviewed and held accountable for meetingCPI standards for Hematopoietic Transplants (HCT). To be compliant with CPI standards, there are threerequirements:

1. A signed Data Transmission Agreement (DTA) or updated Master Healthcare Data and SampleSubmission Agreement (MHA)

2. Meeting the requirements of consecutive reporting of HCT which includes centers centers submittingtheir complete list, registering CRIDs for any unregistered patients, resolving invalid CRIDs that do not


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exist in FormsNet3℠ (FN3), and resolving data discrepancies (i.e. mismatches) that were foundbetween center-provided lists and FN3

3. A minimum of 90% of forms completed error free for hematopoietic cell transplant (HCTs) performedsince January 1, 2016 to present (this will be implemented according to the schedule below). Pleasesee the Recipient CPI Summary Report section for more details regarding what forms are included

• HCT◦ All three time periods

At this time only centers in Australia, New Zealand, and Brazil will be included in the Non-U.S. Center CPIPilot Program.

Non-U.S. CPI Trimesters are:

• November 1 – February 28/29• March 1 – June 30• July 1 – October 31

Below is the comprehensive implementation plan:

• To meet CPI requirements and be in “good standing” as of July 1, 2020 you must complete andsubmit 60% of forms due for:

◦ Previous trimester: earliest complete dates of November 1, 2018 through February 29, 2020◦ 3 prior trimesters (previous year): November 1, 2018 – October 31, 2019◦ Historic: January 1, 2016 – October 31, 2018◦ In addition, centers will also need to submit a list of HCTs performed January 1, 2016 – June

30, 2019 via CIBMTR Center Support (https://nmdp.service-now.com/csm)▪ Your center will receive more information in March 2020

• To meet CPI requirements and be in “good standing” as of November 1, 2020 you mustcomplete and submit 75% of forms due for:

◦ Previous trimester: earliest complete dates of March 1, 2020 through June 30, 2020◦ 3 prior trimesters (prior year): March 1, 2019 – February 29, 2020◦ Historic: January 1, 2016 – February 28, 2019◦ In addition, your center must Register any transplant performed January 1, 2016 – June 30,

2019 that are not in FormsNet SM

• To meet CPI requirements and be in “good standing” as of March 1, 2021 you must completeand submit 90% forms due for:

◦ Previous trimester: earliest completion dates of July 1, 2020 through October 31, 2020◦ 3 prior trimesters (prior year): July 1, 2019 – June 30, 2020◦ Historic: January 1, 2016 – June 30, 2019◦ In addition, your center must submit resolution of discrepancies via CIBMTR Center Support

(https://nmdp.service-now.com/csm) once your center has made the necessary corrections in

FormsNet SM


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For more information, please refer to the Data Management Guide (https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/getting-started). If you have any additional questions or concerns,please submit a ticket via CIBMTR Center Support (https://nmdp.service-now.com/csm) by selecting CPI,IRB, MHA/DTA and then CPI.

Last modified: Jan 13, 2020


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https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/getting-started

https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/getting-started


Center Forms Due Communication Updates2019Starting in March 2019 (non-US centers may be slightly later), the Recipient Forms Due list will beautomatically sent to current Primary Data Managers and staff indicated as cc-PDM. This will correspondwith a retirement of the previous Weekly Forms Due report that was sent to Primary Data Managers.Centers in the United States are familiar with the Recipient Forms Due list, as it is the same as the list offorms included in the CPI form completion requirement previously sent by a center’s CRC. Non-US centersshould consider this a complete forms due list, as the requirements for CPI in the pilot centers is not asencompassing at this time.

The biggest differences between the CPI Forms Due lists and the retired Weekly Forms Due list is formswhich are included in the CPI list are based on the “Earliest Complete Date” and the CPI trimester windows,while the Weekly Forms Due report was based on the “Earliest Complete Date” only. CIBMTR expectscenters to be able to complete forms near the Earliest Complete Date and by the forms’ Due Dates. If a formis on the CPI Forms Due list it is past the date it could have been completed and is likely overdue. The CPIForms Due list also excludes forms due for Autologous infusions for an event date prior to 12/3/2007.



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Recipient Forms Due ListThe Recipient Forms Due list will be automatically sent to current Primary Data Managers and staffindicated as cc-PDM. Centers in the United States should use this list of forms to know what is included inthe CPI form completion requirement. Non-US centers should consider this a complete forms due list, as therequirements for CPI in the pilot centers is not as encompassing. Please see directions under the manualsection titled FormsNet Forms Due Lists for details on how to make this ‘forms due’ list more reflective of aninternational CPI requirement.

Effective May 1, 2018 forms will be considered due based on form status. All forms in the following statusDUE, SVD, QRY, ERR, and MOD will be considered incomplete. Note: Autologous forms with an event dateprior to 12/3/2007 are currently excluded from CPI and therefore are not included on the Recipient FormsDue list. Consider using the Forms Due feature in FormsNet to get a list of these forms. Please be sure tocomplete the Indication for CRID Assignment Form 2814, the Pre-TED Forms 2400 and 2402, and the Pre-Cellular Therapy Essential Data Form 4000 as soon as possible to ensure the HCT type and treatment pathare accurately reported and applicable forms for the CRID come due.

The forms due lists are sorted by CRID to facilitate data entry. The earliest complete dates are listed underthe column “Earliest”. Recipient Summary report values are broken into twelve categories for US centers orsix categories for Non-US centers as HCT product types are combined. Additional details regarding thesummary information can be found in the Summary Report section. Centers are responsible for determiningwhich category each form fits in regards to the time frame and infusion type. The two “Study” columnsinclude the first and last alphabetical study name. If a CRID is on more than two studies, the middlealphabetical study names will not be available on the forms due report. Please note, completing forms usedin CIBMTR studies should be a priority for centers, By the time these forms are included on the RecipientForms Due or the Study Forms Due reports they are considered overdue by CIBMTR. The “Created By”column is available for most CRIDs, especially newer CRIDs, and gives the user name of the person whoentered the initial CRID information into FormsNet. This is available for center use to help divide work and isnot used by CIBMTR staff at this time. Treatment paths are listed as 1 for HCT and 2 for CT. If the value isblank, these forms will count against the center for all four summary types.

The number of forms required to meet your CPI requirement is subject to change until the close of thetrimester. Some forms once completed, such as the Pre-TED Form 2400/2402, trigger other forms to bedue. The forms that come due will count for CPI if their earliest complete date falls into the applicable timeperiods. If the HCT type (US only) or treatment path are not available for a CRID it will count against thecenter in each potentially applicable summary value.



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Recipient CPI Summary ReportThe Recipient CPI Summary Report will be automatically sent to current Primary Data Managers and staffindicated as cc-PDM. Information regarding US CPI metrics including form completion status and currentIRB documentation will be included in this report.

Each center will be held accountable for completing 90% of forms for multiple categories. If a center fails toachieve 90% in any of these categories by the end of the day (Central Time) prior to the close of thetrimester, they will be considered failing CPI for that trimester. US centers have twelve total categories,including three HCT product types and CT forms at each of three time periods. Non-US centers will also seethe HCT product types and CT forms, but only HCT categories count towards CPI.

Summary percentages reflect a total count of forms. Forms are considered complete if they are in AUD,CMP, LCK, and PND as these do not require center action (effective May 1, 2018). The summary reportincludes the following information for each of the required categories:

• Total #, includes the total number of forms which have been completed or are yet to be completed.Forms in LTF (lost to follow-up), SUR (survival), or NRQ (no longer required) statuses are excludedfrom this count.

• Due Forms, includes forms in DUE, QRY, SVD, ERR, and MOD status with a complete date that fallsafter the end of the Trimester (Midnight Central prior to the trimester end date).

• %Complete, these are the summary values your center is accountable for. All of these values must beabove or equal to 90. They are calculated by taking (Total # – Due forms) / Total #. Please note,these values do not get rounded.

The product types are divided into the following categories (US Centers only):

• Allogenic Related (Allo_R)• Allogenic Unrelated (Allo_U)• Autologous (Auto)• Cellular Therapies (CT)*

*CT product reporting is only applicable for US Centers


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The other CPI requirements will be presented at the bottom of the report. Please note, these additionalitems are currently being finalized:

Other CPI Requirements:

IRB Expiration Date (US Centers only)

MHA / DTA: TBD (Non-US Centers only)

Met CTA Requirements: TBD

Met AGNIS Requirements (if applicable): TBD

US Centers:

The time periods include forms with the following earliest complete dates:

1. Forms with a date that fell in the most recent trimester:

• January Trimester closing December 31st at 11:59 P.M. Central includes forms with an earliestcomplete date of May 1 – August 31

• May Trimester closing April 30th at 11:59 P.M. Central includes forms with an earliest complete dateof September 1 – December 31

• September Trimester closing August 31st at 11:59 P.M. Central includes forms with an earliestcomplete date between January 1 – April 30

2. A full year prior to the most recent trimester

3. All other forms due which centers are held accountable:

• Allo_R, Allo_U, and CT• Auto, events 12/3/2007 and later


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Non-US Centers:

The time periods include forms with the following earliest complete dates (Note, these time periods are amonth earlier in the year compared to US centers):

1. Forms with a date that fell in the most recent trimester:

• March Trimester closing June 30th at 11:59 P.M. Central includes forms with an earliest completedate of November 1st – February 28/29th

• July Trimester closing October 31st at 11:59 P.M. Central includes forms with an earliest completedate of March 1st – June 30th

• November Trimester closing February 28/29th at 11:59 P.M. Central includes forms with an earliestcomplete date between July 1st – October 31st

2. A full year prior to the most recent trimester

3. All other forms due which centers are held accountable:

• The following should be excluded from CIBMTR Reporting◦ Any transplants that occurred prior to reporting to CIBMTR◦ Data that should not be submitted to CIBMTR per local regulatory rules◦ If your center performs, but does not report autologous HCTs to CIBMTR

Please contact CIBMTR if you believe a CRID or Forms are included in FormsNet in error.


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ComplianceTo be compliant with CPI standards, there are three requirements:

1. Having current IRB documents (renewal letters and consents) on file with NMDP including thefollowing:

• Current IRB Documents• Approval letters• Approved consents

2. Meeting the requirements of consecutive reporting of hematopoietic transplants (HCT) which includescenters submitting their complete list, registering CRIDs for any unregistered patients, resolvinginvalid CRIDs that do not exist in FormsNet3℠, and resolving data discrepancies (i.e. mismatches)that were found between center-provided lists and FormsNet3℠

3. Form completion of at least 90% of the required forms for four product types at each of three timeperiods (January 1 – April 30th, May 1 – August 31st, September 1 – December 31st)

• Allogeneic Related form completion (for applicable centers)◦ All three time periods

• Allogeneic Unrelated form completion (for applicable centers)◦ All three time periods

• Autologous form completion (for applicable centers)◦ All three time periods

• Cellular Therapy form completion (for applicable centers)◦ All three time periods

Compliance will be enforced according to the following schedule:

A center meets CPI and is considered in “Good Standing” by meeting all of the standards of CPI. A centerthat fails to meet any of the three CPI standards is given a non-compliance status. Below is the non-compliance schedule:

• First Warning: First failure• Probation: Second consecutive failure• Suspension: Third consecutive failure

One successful trimester, in all of the standards, returns the center to Good Standing.

A center that fails to comply with the above during the CPI period will receive a letter from the CIBMTRSenior Manager informing them that they did not meet all the CPI goals. By the next trimester, the centermust return all standards to Good Standing or they will be moved to the next stage of non-compliance.

Reporting cellular therapy infusions to the CIBMTR remains voluntary at this time. However,IF the infusions are reported, THEN the forms will be held to CPI.*


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While there may not be any direct consequences to being in First Warning or Probation status, CIBMTRencourages centers to return to good standing as soon as possible. This ensures the database is ascomplete and accurate as possible. Please work with your center’s CRC if you have any questions abouthow to best return to good standing.

If a center did not meet CPI due to non-compliance in Allogeneic Related form completion one trimester andfails to meet the IRB requirements the next will be moved on to the next level of non-compliance. Allstandards must be met to return the center to Good Standing.

A center that reaches “Suspension” status could be suspended from initiating new patient searches for aNMDP donor and from participating in CIBMTR leadership activities. Failure to submit the forms may alsoaffect Center Volume reporting and the Center Specific Analysis. Failure to report data to CIMBTR in atimely and accurate manner affects the quality of the database and ultimately could affect published reports.

CIBMTR Management may contact the Medical Director or Primary Data Manager of a center at any time acenter has not met all of the CPI standards.



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CPI FormsThe following forms are counted towards CPI. Please note: any forms that have since been retired are stillcounted towards CPI.

The following forms are included in CPI counts if they are associated with an HCT infusion:

Form numbers: 2000 – 2006Form numbers: 2010 – 2450Form numbers: 2500 – 2565Form numbers: 2814 and 2900Form numbers: 3500 and 3501

The following forms are included in CPI counts if they are associated with a CT Infusion:

Form number: 2005Form numbers: 2010 – 2402Form numbers: 2814 and 2900Form numbers: 3500 and 3501Form numbers: 4000 – 4100

The following forms are currently excluded from CPI:

Form numbers: 2008, 2800, and 2801Form numbers: 5000 – 5002



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Consecutive ReportingTo ensure continued epidemiological integrity of the outcomes registry basic transplant data is required forall HCT infusion that have occurred at each center. This includes patients with one to multiple infusions butdoes not include autologous HCTs if these are not otherwise reported to CIBMTR. International centers mayonly report infusion date, type and product type, however United States centers must submit data on thePre-TED Forms 2400 and 2402 for all infusions regardless of consent.



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Primary Disease and Disease Forms DueThis section is useful for determining which disease inserts should be completed for the disease reported ona recipient’s Disease Classification Form 2402. The disease insert should appear in FormsNet for those onthe CRF track after the Pre-TED Form 2400 and Disease Classification Form 2402 are submitted, and forcellular therapy patients once the Pre-CTED Form 4000 and Disease Classification Form 2402 aresubmitted. No disease inserts are due for those on the TED reporting track.



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Acute myelogenous leukemia (AML or ANLL)

Disease Subtype(s) HCT DiseaseInserts required

Cellular Therapy DiseaseInserts required

AML with recurrent genetic abnormalities• AML with t(9;11) (p22.3;q23.3); MLLT3-KMT2A

(5)• AML with t(6;9) (p23;q34.1); DEK-NUP214 (6)• AML with inv(3) (q21.3;q26.2) or t(3;3)

(q21.3;q26.2); GATA2, MECOM (7)• AML (megakaryoblastic) with t(1;22)

(p13.3;q13.3); RBM15-MKL1 (8)• AML with t(8;21); (q22; q22.1); RUNX1-RUNX1T1

(281)• AML with inv(16)(p13.1;1q22) or t(16;16)(p13.1;

q22); CBFB-MYH11 (282)• APL with PML-RARA (283)• AML with BCR-ABL1 (provisional entity) (3)• AML with mutated NPM1 (4)• AML with biallelic mutations of CEBPA (297)• AML with mutated RUNX1 (provisional entity)

(298)• AML with 11q23 (MLL) abnormalities (i.e., t(4;11),

t(6;11), t(9;11), t(11;19)) (284)• AML with myelodysplasia – related changes (285)• Therapy related AML (t-AML) (9)

Forms 2010 & 2110 No disease inserts required

AML, not otherwise specified• AML, not otherwise specified (280)• AML, minimally differentiated (286)• AML without maturation (287)• AML with maturation (288)• Acute myelomonocytic leukemia (289)• Acute monoblastic / acute monocytic leukemia (290)• Acute erythroid leukemia (erythroid / myeloid and pure erythroleukemia) (291)• Acute megakaryoblastic leukemia (292)• Acute basophilic leukemia (293)• Acute panmyelosis with myelofibrosis (294)• Myeloid sarcoma (295)• Myeloid leukemia associated with Down syndrome (299)

Forms 2010 & 2110


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Acute lymphoblastic leukemia (ALL)



B-lymphoblastic leukemia / lymphoma• B-lymphoblastic leukemia / lymphoma, NOS (B-cell

ALL, NOS) (191)• B-lymphoblastic leukemia / lymphoma with

t(9;22)(q34.1;q11.2); BCR-ABL1 (192)• B-lymphoblastic leukemia / lymphoma with

t(v;11q23.3); KMT2A rearranged (193)• B-lymphoblastic leukemia / lymphoma with

t(1;19)(q23;p13.3); TCF3-PBX1 (194)• B-lymphoblastic leukemia / lymphoma with t(12;21)

(p13.2;q22.1); ETV6-RUNX1 (195)• B-lymphoblastic leukemia / lymphoma with t(5;14)

(q31.1;q32.3); IL3-IGH (81)• B-lymphoblastic leukemia / lymphoma with

Hyperdiploidy (51-65 chromosomes) (82)• B-lymphoblastic leukemia / lymphoma with

Hypodiploidy (<45 chromosomes) (83)• B-lymphoblastic leukemia / lymphoma,

BCR-ABL1-like (provisional entity) (94)• B-lymphoblastic leukemia / lymphoma, with iAMP21

(provisional entity) (95)• T-cell lymphoblastic leukemia / lymphoma• Early T-cell precursor lymphoblastic leukemia

(provisional entity) (96)• Natural killer (NK)- cell lymphoblastic leukemia /

lymphoma (provisional entity) (97)

Form 2011 & 2111 Form 2011/2011



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Acute Leukemias of Ambiguous Lineage andOther Myeloid Neoplasms



• Blastic plasmacytoid dendritic cell neoplasm (296)• Acute undifferentiated leukemia (31)• Mixed phenotype acute leukemia (MPAL) with

t(9;22)(q34.1;q11.2); BCR-ABL1 (84)• Mixed phenotype acute leukemia with t(v;

11q23.3); KMT2A rearranged (85)• Mixed phenotype acute leukemia, B/myeloid, NOS

(86)• Mixed phenotype acute leukemia, T/myeloid, NOS

(87)• Other acute leukemia of ambiguous lineage or

myeloid neoplasm (88)

Forms 2010 &2110 No disease insert required



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Chronic myelogenous leukemia (CML)Disease Subtype(s) HCT Disease Inserts required Cellular Therapy Disease Inserts required

• Ph+ / bcr+ (41)• Ph+ / bcr- (42)• Ph+ / bcr unknown (43)• Ph- / bcr+ (44)• Ph unknown / bcr+ (47)




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Myelodysplastic (MDS) / myeloproliferative(MPN)

Disease Subtype(s)

HCTDiseaseInsertsrequired

CellularTherapyDiseaseInsertsrequired

MDS• Refractory cytopenia with unilineage dysplasia (RCUD) (includes

refractory anemia (RA)) (51)• Refractory anemia with ringed sideroblasts (RARS) (55)• Refractory anemia with excess blasts-1 (RAEB-1) (61)• Refractory anemia with excess blasts-2 (RAEB-2) (62)• Refractory cytopenia with multilineage dysplasia (RCMD) (64)• Childhood myelodysplastic syndrome (Refractory cytopenia of

childhood (RCC)) (68)• Myelodysplastic syndrome with isolated del(5q) (5q– syndrome) (66)• Myelodysplastic syndrome (MDS), unclassifiable (50)*+MPN+*• Chronic neutrophilic leukemia (165)• Chronic eosinophilic leukemia, NOS (166)• Essential thrombocythemia (includes primary thrombocytosis,

idiopathic thrombocytosis, hemorrhagic thrombocythemia) (58)• Polycythemia vera (PCV) (57)• Primary myelofibrosis (includes chronic idiopathic myelofibrosis

(CIMF), agnogenic myeloid metaplasia (AMM), myelofibrosis/sclerosiswith myeloid metaplasia (MMM), idiopathic myelofibrosis) (167)

• Myeloproliferative neoplasm (MPN), unclassifiable (60)MPN

• Chronic neutrophilic leukemia (165)• Chronic eosinophilic leukemia, NOS (166)• Essential thrombocythemia (includes primary thrombocytosis,

idiopathic thrombocytosis, hemorrhagic thrombocythemia) (58)• Polycythemia vera (PCV) (57)• Primary myelofibrosis (includes chronic idiopathic myelofibrosis

(CIMF), agnogenic myeloid metaplasia (AMM), myelofibrosis/sclerosiswith myeloid metaplasia (MMM), idiopathic myelofibrosis) (167)

• Myeloproliferative neoplasm (MPN), unclassifiable (60)MDS / MPN

• Chronic myelomonocytic leukemia (CMMoL) (54)• Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69)

Forms2014 &2114

No diseaseinsert required


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• Juvenile myelomonocytic leukemia(JMML/JCML)(no evidence of Ph1 or BCR/ABL)(36)


• Atypical chronic myeloid leukemia, Ph-/bcr/abl-{CML, NOS} (45)

• Atypical chronic myeloid leukemia, Ph-/bcr unknown{CML, NOS} (46)

• Atypical chronic myeloid leukemia, Ph unknown/bcr-{CML, NOS} (48)

• Atypical chronic myeloid leukemia, Ph unknown/bcrunknown {CML, NOS} (49)




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Other Leukemia

Disease Subtype(s) HCT Disease Insertsrequired

Cellular Therapy Disease Insertsrequired

• Chronic lymphocytic leukemia (CLL),NOS (34)

• Chronic lymphocytic leukemia (CLL)• B-cell / small lymphocytic lymphoma

(SLL) (71)

Form 2013 & 2113 Form 2013 & 2113

• Hairy cell leukemia (35) No disease insertrequired No disease insert required

• Prolymphocytic leukemia (PLL), NOS(37)

• PLL, B-cell (73)• PLL, T-cell (74)

Form 2013 & 2113 Form 2013 & 2113

• Other leukemia, NOS (30)• Other leukemia (39)

Form 2010 & 2110 No disease insert required



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Hodgkin Lymphoma



• Nodular lymphocyte predominant Hodgkinlymphoma (155)

• Lymphocyte-rich (151)• Nodular sclerosis (152)• Mixed cellularity (153)• Lymphocyte depleted (154)• Hodgkin lymphoma, NOS (150)

Form 2018 & 2118 No disease inserts required



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Non-Hodgkin Lymphoma

Disease Subtype(s)

HCTDiseaseInsertsrequired

Cellular TherapyDisease Insertsrequired

B-cell neoplasms• Splenic marginal zone B-cell lymphoma (124)• Extranodal marginal zone B-cell lymphoma of mucosal

associated lymphoid tissue type (MALT) (122)• Nodal marginal zone B-cell lymphoma (± monocytoid B-cells)

(123)• Follicular, predominantly small cleaved cell (Grade I follicle

center lymphoma) (102)• Follicular, mixed, small cleaved and large cell (Grade II follicle

center lymphoma) (103)• Follicular, predominantly large cell (Grade IIIA follicle center

lymphoma) (162)• Follicular, predominantly large cell (Grade IIIB follicle center

lymphoma) (163)• Follicular (grade unknown) (164)• Mantle cell lymphoma (115)• Intravascular large B-cell lymphoma (136)• Primary mediastinal (thymic) large B-cell lymphoma (125)• Primary effusion lymphoma (138)• Diffuse, large B-cell lymphoma — NOS (107)• Burkitt lymphoma (111)• B-cell lymphoma, unclassifiable, with features intermediate

between DLBCL and Burkitt lymphoma (140)• B-cell lymphoma, unclassifiable, with features intermediate

between DLBCL and classical Hodgkin Lymphoma (149)• T-cell / histiocytic rich large B-cell lymphoma (120)• Primary diffuse large B-cell lymphoma of the CNS (118)• Other B-cell lymphoma (129)

T-cell / NK cell neoplasms• Extranodal NK / T-cell lymphoma, nasal type (137)• Enteropathy-type T-cell lymphoma (133)• Hepatosplenic T-cell lymphoma (145)• Subcutaneous panniculitis-like T-cell lymphoma (146)• Mycosis fungoides (141)• Sezary syndrome (142)• Primary cutaneous CD30+ T-cell lymphoproliferative disorders

Forms 2018& 2118

Forms 2018 &2118


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[Primary cutaneous anaplastic large-cell lymphoma (C-ALCL),lymphoid papulosis] (147)

• Peripheral T-cell lymphoma (PTCL), NOS (130)• Angioimmunoblastic T-cell lymphoma (131)• Anaplastic large-cell lymphoma (ALCL), ALK positive (143)• Anaplastic large-cell lymphoma (ALCL), ALK negative (144)• T-cell large granular lymphocytic leukemia (126)• Aggressive NK-cell leukemia (27)• Adult T-cell lymphoma / leukemia (HTLV1 associated) (134)• Other T-cell / NK-cell lymphoma (139)



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NHL-Waldenstrom



• Waldenstrom macroglobulinemia /Lymphoplasmacytic lymphoma (173)

Forms 2019 & 2119 No disease insert required



Page 71 of 95

Multiple Myeloma/Plasma Cell Disorder (PCD)



• Multiple myeloma-lgG (181)• Multiple myeloma-lgA (182)• Multiple myeloma-lgD (183)• Multiple myeloma-lgE (184)• Multiple myeloma-lgM (not Waldenstrom

macroglobulinemia) (185)• Multiple myeloma-light chain only (186)• Multiple myeloma-non-secretory (187)• Plasma cell leukemia (172)• Solitary plasmacytoma (no evidence of

myeloma) (175)• Amyloidosis (174)• Osteosclerotic myeloma / POEMS syndrome

(176)• Light chain deposition disease (177)• Other plasma cell disorder (179)




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Solid Tumors



• Breast cancer (250) No disease insertrequired No disease insert required

• Lung, small cell (202)• Lung, non-small cell (203)• Lung, not otherwise specified (230)

No disease insertrequired No disease insert required

• Germ cell tumor, extragonadal (225)• Testicular (210)

Form 2022/2122 No disease insert required

• Ovarian (epithelial) (214) No disease insertrequired No disease insert required

• Bone sarcoma (excluding Ewing familytumors) (273)

• Ewing family tumors of bone (includingPNET) (275)

• Ewing family tumors, extraosseous(including PNET) (276)

• Fibrosarcoma (244)• Hemangiosarcoma (246)• Leiomyosarcoma (242)• Liposarcoma (243)• Lymphangio sarcoma (247)• Neurogenic sarcoma (248)• Rhabdomyosarcoma (232)• Synovial sarcoma (245)• Soft tissue sarcoma (excluding Ewing

family tumors) (274)

Form 2024/2124 No disease insert required

• Central nervous system tumor, includingCNS PNET (220)

• Medulloblastoma (226)Form 2025/2125 No disease insert required

• Neuroblastoma (222) Form 2026/2126 No disease insert required

• Head / neck (201)• Mediastinal neoplasm (204)• Colorectal (228)• Gastric (229)• Pancreatic (206)



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• Hepatobiliary (207)• Prostate (209)• External genitalia (211)• Cervical (212)• Uterine (213)• Vaginal (215)• Melanoma (219)• Wilm tumor (221)• Retinoblastoma (223)• Thymoma (231)• Other solid tumor (269)• Solid tumor, not otherwise specified (200)

• Renal cell No disease insertrequired No disease insert required



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Severe Aplastic Anemia

Disease Subtype(s) HCT DiseaseInserts

Cellular Therapy DiseaseInserts

• Acquired severe aplastic anemia, not otherwisespecified (301)

• Acquired SAA secondary to hepatitis (302)• Acquired SAA secondary to toxin / other drug

(303)• Acquired amegakaryocytosis (not congenital)

(304)• Acquired pure red cell aplasia (not congenital)

(306)• Other acquired cytopenic syndrome (309)


• Dyskeratosis congenital (307) No disease insertrequired No disease insert required



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Inherited abnormalities of erythrocytedifferentiation or function

Disease Subtype(s) HCT Disease Inserts Cellular Therapy DiseaseInserts

• Paroxysmal nocturnal hemoglobinuria (PNH)(56)

• Shwachman-Diamond (305)• Diamond-Blackfan anemia (pure red cell

aplasia) (312)• Other constitutional anemia (319)


• Sickle thalassemia (355)• Sickle cell disease (356)


• Beta thalassemia major (357)• Other hemoglobinopathy (359)


• Fanconi anemia (311) Form 2029 & 2129 No disease insert required



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Disorders of the immune system

Disease Subtype(s)HCTDiseaseInserts

Cellular TherapyDisease Inserts

• Adenosine deaminase (ADA) deficiency / severe combinedimmunodefiency (SCID)(401)

• Absence of T and B cells SCID (402)• Absence of T, normal B cell SCID (403)• Omenn syndrome (404)• Reticular dysgenesis (405)• Bare lymphocyte syndrome (406)• Other SCID (419)• SCID, not otherwise specified (410)• Ataxia telangiectasia (451)• HIV infection (452)• DiGeorge anomaly (454)• Common variable immunodeficiency (457)• Leukocyte adhesion deficiencies, including GP180, CD-18,

LFA and WBC adhesion deficiencies (459)• Kostmann agranulocytosis (congenital neutropenia) (460)• Neutrophil actin deficiency (461)• Cartilage-hair hypoplasia (462)• CD40 ligand deficiency (464)• Other immunodeficiencies (479)• Immune deficiency, not otherwise specified (400)

Forms 2031& 2131

No disease insertrequired



• Chediak-Higashi syndrome (456)• Griscelli syndrome type 2 (465)• Hermansky-Pudlak syndrome type 2 (466)


• Chronic granulomatous disease (455) Forms 2055 & 2155 No disease insert required

• Wiskott-Aldrich syndrome (453) Forms 2033 & 2133 No disease insert required

• X-linked lymphoproliferative syndrome(458)




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Inherited abnormalities of platelets



• Congenital amegakaryocytosis / congenitalthrombocytopenia (501)

Forms 2035 & 2135 No disease insert isrequired

• Glanzmann thrombasthenia (502)• Other inherited platelet abnormality (509)




Page 78 of 95

Inherited disorders of metabolism



• Osteopetrosis(malignant infantile osteopetrosis)(521)


Metachromatic leukodystrophy (MLD) (542)• Adrenoleukodystrophy (ALD) (543)• Krabbe disease (globoid leukodystrophy) (544)


• Lesch-Nyhan (HGPRT deficiency) (522)• Neuronal ceroid lipofuscinosis (Batten disease) (523)

Mucopolysaccharidosis• Hurler syndrome (IH) (531)• Scheie syndrome (IS) (532)• Hunter syndrome (II) (533)• Sanfilippo (III) (534)• Morquio (IV) (535)• Maroteaux-Lamy (VI) (536)• β-glucuronidase deficiency (VII) (537)• Mucopolysaccharidosis (V) (538)• Mucopolysaccharidosis, not otherwise specified (530)• Gaucher disease (541)• Niemann-Pick disease (545)• I-cell disease (546)• Wolman disease (547)• Glucose storage disease (548)• Mucolipidoses, not otherwise specified (540)

Polysaccharide hydrolase abnormalities• Aspartyl glucosaminidase (561)• Fucosidosis (562)• Mannosidosis (563)• Polysaccharide hydrolase abnormality, not otherwise

specified (560)• Other inherited metabolic disorder (529)• Inherited metabolic disorder, not otherwise specified

(520)




Page 79 of 95

Histiocytic disorders

Disease Subtype(s) HCT Disease Inserts Cellular Therapy DiseaseInserts

• Hemophagocytic lymphohistiocytosis (HLH)(571)

Form 2039 & 2139 No Disease Insert Required

• Langerhans cell histiocytosis (histiocytosis-X)(572)

Form 2040 & 2140 No Disease Insert Required

• Hemophagocytosis (reactive or viralassociated) (573)

• Malignant histiocytosis (574)• Other histiocytic disorder (579)• Histiocytic disorder, not otherwise specified

(570)

No Disease InsertRequired No Disease Insert Required



Page 80 of 95

Autoimmune diseases



• Rheumatoid arthritis(603) Form 2041 & 2141 No disease insert required

• Psoriatic arthritis / psoriasis (604)• Juvenile idiopathic arthritis (JIA): systemic (Stills

disease) (640)• JIA: oligoarticular (641)• JIA: polyarticular (642)• JIA: other (643)• Other arthritis (633)


• Multiple sclerosis Form 2043 & 2143 No disease insert required

• Systemic sclerosis Form 2044 & 2144 No disease insert required

• Systemic lupus erythematosis (SLE) (605) Form 2045 & 2145 No disease insert required

Connective tissue diseases• Sjögren syndrome (608)• Polymyositis / dermatomyositis (606)• Antiphospholipid syndrome (614)• Wegener granulomatosis (610)• Classical polyarteritis nodosa (631)• Microscopic polyarteritis nodosa (632)• Churg-Strauss (635)• Giant cell arteritis (636)• Takayasu (637)• Behcet syndrome (638)• Overlap necrotizing arteritis (639)• Other vasculitis (611)

Other neurologic autoimmune disease• Myasthenia gravis (601)• Other autoimmune neurological disorder (644)

Hematologic autoimmune disease• Idiopathic thrombocytopenic purpura (ITP) (645)• Hemolytic anemia (646)• Evan syndrome (647)• Other autoimmune cytopenia (648)

Bowel disease• Crohn’s disease (649)• Ulcerative colitis (650)



Page 81 of 95

• Other autoimmune bowel disorder (651)



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Current Form RevisionThe following forms are currently being revised / developed. Check back for new forms, and updates to theanticipated release dates.

Forms Anticipated ReleaseDate Notes

Recipient Contact Information (2820) Summer 2019

Inotuzumab Ozogamicin (2541) Summer 2019

BMT CTN 1702 Adverse Event Form (2535) Summer 2019 new study specific form

BMT CTN 1702 Off Study Form (2536) Summer 2019 new study specific form

BMT CTN 1702 Protocol Deviation / Violation Form(2537) Summer 2019 new study specific form

Pre-TED (2400) Fall 2019 Currently being reviewed /revised.

Disease Classification (2402) Fall 2019 Currently being reviewed /revised.

Baseline (2000) Fall 2019 Currently being reviewed /revised.

HCT Product and Infusion (2006) Fall 2019 Currently being reviewed /revised.

Confirmation of HLA typing form (2005) Fall 2019 Currently being reviewed /revised.

Infectious disease markers (2004) Fall 2019 Currently being reviewed /revised.

Post-TED (2450) Fall 2019 Currently being reviewed /revised.

Multiple Myeloma / PCD Pre-Infusion Form (2016) Fall 2019 underwent complete revision

Multiple Myeloma / PCD Post-Infusion Form (2116) Fall 2019 underwent complete revision

For more information about the forms, or revision schedule, email [email protected].

Last modified: Jul 03, 2019


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Protocols and ConsentsTransplant centers are expected to approach all recipients for consent to participate in the ClinicalOutcomes Research Database.

Centers participating in the Research Sample Repository should approach all unrelated recipients, as wellas all related donor/recipient pairs at participating centers, to obtain consent to the Research SampleRepository.

Last modified: Dec 20, 2017


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US Transplant CentersUnited States Transplant Centers – Institutional Review Board (IRB) Approval:

To be compliant with United States Federal Regulations for human research subject protection, transplantcenters must obtain IRB-approved informed consent from recipients to allow data submitted to theObservational Database to be used for research studies. All transplant centers must have local IRBapproval for the Observational Database Research protocol. This includes all transplant centersparticipating as TED only and Comprehensive Report Form centers. All transplant centers that are NMDPmember centers must also have local IRB approval for the Research Sample Repository protocol forunrelated recipients.

• The transplant centers participating in the Related Transplant Research Repository will submitresearch samples on related recipients and their donors in addition to the samples on unrelated donorrecipients.

• Transplant centers that perform related donor HCTs and do not participate in the Related TransplantResearch Repository will not submit research samples, and therefore do not need to obtain local IRBapproval for the repository protocol.

The NMDP and CIBMTR have written protocols and informed consent documents for the ObservationalDatabase and Research Sample Repository. The protocols and consent documents should be downloadedfrom the CIBMTR website and submitted to the transplant center’s local IRB for review and approval. Theprotocols and consent forms must be submitted to the local IRB as written by the NMDP and CIBMTR;however, the documents may be formatted according to each site’s requirements. The ObservationalDatabase and Research Sample Repository protocols and consent forms can be obtained from the CIBMTRwebsite – click here.

Upon obtaining local IRB approval, the NMDP IRB Office must receive a copy of the local IRB’s approvalletter, approved protocol and informed consent documents. The NMDP IRB Office tracks the IRB approvalfor the Observational Database and Research Repository protocols at each participating center. Sites willreceive a renewal reminder approximately two months in advance of the local continuing review date. TheCIBMTR Clinical research coordinators (CRCs) also send notice of the IRB expiration date to the primarydata manager with the center’s monthly CPI reports. Local IRB approval for these protocols must be currentat all times. Failure to have current local IRB approval can impact a center’s ability to meet CPIrequirements for data and sample submission.

If the allogeneic recipient does not consent to participate in the Observational Database, the transplantcenter will still be required to submit TED-level data on the recipient. The CIBMTR will not use therecipient’s data for research studies. However, the data provided on the TED forms will be used forevaluation of the C.W. Bill Young Cell Transplantation Program, and federally required analysis such ascenter volumes and center-specific analysis, mandated by CIBMTR’s contract to operate the Stem Cell


Page 85 of 95

https://www.cibmtr.org/DataManagement/ProtocolConsent/Pages/index.aspx

Therapeutic Outcomes Database (SCTOD). This applies to recipients of allogeneic (related and unrelated)HCT. For autologous recipients who do not consent to participate in research, the CIBMTR requests thecompletion of CRID Assignment Form 2804, the Indication for CRID Assignment Form 2814, the Pre-Transplant Essential Data Form 2400, and the Pre-TED Disease Classification Form 2402, each indicatingconsent to research as ‘no’. This reporting will help ensure that the epidemiological integrity of the databaseis maintained, and the recipient’s information will not be used in research.

NOTE:

Submit IRB approval documents to the CIBMTR Research Administration designee. For contact information,contact your CIBMTR CRC.



Page 86 of 95

International CentersInternational Centers – Institutional Review Board (IRB) Approval

International transplant centers must follow their country’s laws and regulations governing human subjectsand privacy protection. The transplant center is responsible for obtaining the necessary institutional reviewand approval for the Observational Database.

If the recipient does not consent to participate in the Observational Database according to the laws andregulations of their country, the CIBMTR requests the completion of CRID Assignment Form 2804, theIndication for CRID Assignment Form 2814, the Pre-Transplant Essential Data Form 2400, and the Pre-TEDDisease Classification Form 2402, each indicating consent to research as ‘no’. This reporting will helpensure that the epidemiological integrity of the database is maintained, and the recipient’s information willnot be used in research. This applies to recipients of allogeneic (related and unrelated) and autologousHCT.



Page 87 of 95

Observational DatabaseWhen a recipient consents to participate in research, their data are contained in the CIBMTR’sObservational Database. The database includes recipient baseline and outcome data for related andunrelated allogeneic transplants or other cellular therapy from any cell source, and for autologoustransplants or other cellular therapy. Data are also collected on unrelated donors and their donationexperiences.

The primary purpose of the Observational Database is to have a comprehensive source of data that canbe used to study hematopoietic cell transplantation.

Studies in which these data may be used include:

• How well recipients recover from their transplants or cellular therapy• How recovery after transplantation or cellular therapy can be improved• Long-term outcomes after transplantation or cellular therapy• How access to transplantation or cellular therapy for different groups of recipients can be improved,

including studies designed to inform insurance/payer policy, such as U.S. Medicare policy• How well donors recover from collection procedures• The application and success of transplantation in the management of marrow-toxic injuries



Page 88 of 95

Research Sample RepositoryThe Research Sample Repository contains blood samples from unrelated recipients and/or their adultvolunteer donor, or cord blood unit. Related allogeneic recipients and/or donors will participate at selectedtransplant centers.

The primary objective of the Research Repository is to make blood samples available for researchstudies related to histocompatibility and hematopoietic cell transplantation or cellular therapy.

Studies in which these data may be used include:

• Improve the understanding of tissue matching for hematopoietic cell donors and recipients• Determine and evaluate the factors that affect transplant and cellular therapy outcome• Study the distribution of HLA tissue types in different populations (e.g., study tissue typing differences

between different racial and ethnic populations to help develop methods to improve tissue matchingbetween donors and recipients, including testing of rare HLA types)

Last modified: Dec 20, 2017


Page 89 of 95

Online TrainingEducational opportunities are continually being developed as part of our commitment to improving dataquality and providing resources for data managers for data reporting to the CIBMTR.CIBMTR Training has implemented eLearning for easily accessible training which is available wheneverneeded (24/7). For a look at our course menu and immediate access to any eLearning you want to do, visitour Online Training page on our website.



Page 90 of 95

https://www.cibmtr.org/DataManagement/Training/OnlineTraining/Pages/default.aspx

Data Manager MentorsThe Data Manager Mentors are a small group of experienced Data Managers currently working in their owncenters around the world who volunteer to guide new data managers and colleagues in the field of HCT withcenter-related data collection subject matter.

Mission Statement

The mission of the Mentors group is to promote interaction, communication and professional relationshipsamong the Clinical Research Professionals and Data Managers to grow their skills and profession. TheMentors support the goals of the CIBMTR to ensure efficient, high quality data management and to providequality data for high impact clinical research to improve patient outcomes. To help facilitate this, the Mentorswork with the CIBMTR staff to develop educational opportunities and materials, assist in developing the datacollection forms, assist other Clinical Research Professionals and Data Managers in how to organize dailyworkflow and offer their experience and expertise to help new Clinical Research Professionals and DataManagers be successful.

Mentor Goals

• Participate in forms revisions with CIBMTR Staff;• Develop training materials for new Clinical Research Professionals and Data Managers with CIBMTR

Staff;• Participate in planning the Clinical Research Professionals and Data Managers meeting at Tandem

with CIBMTR staff;• Participate in prioritizing enhancements/fixes, testing new functionality/enhancements and offering

feedback for the FormsNet3 application;• Review the CIBMTR and the Mentor web sites to ensure the content on each supplement each other;• Participate in quarterly conference calls between Mentors and CIBMTR staff.

If you would like support help from a mentor, or you are interested in participating in helping us reach ourgoals by becoming a mentor, contact us:

email: [email protected]: [email protected]

(See: Mentors’ Webpage)



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https://www.cibmtr.org/DataManagement/mentors/Pages/index.aspx

AcronymsAA: African AmericanABil: Acute biphenotypic leukemiasAC: apheresis centerACCME: Accreditation Council for Continuing Medical EducationAFA: Anti-fungal agentAGNIS: A Growable Network Information SystemALL: Acute lymphoblastic leukemia, acute lymphocytic leukemiaAML: Acute myelogenous leukemia, acute myeloid leukemiaANC: Absolute neutrophil countARC : American Red CrossASBMT: American Society for Blood and Marrow TransplantationASH: American Society of HematologyASHI: American Society for Histocompatibility and ImmunogeneticsBBMT: Biology of Blood and Marrow TransplantationBMDW: Bone Marrow Donors WorldwideBMT: Blood and marrow transplant / bone marrow transplantBMT CTN: Blood and Marrow Transplant Clinical Trials NetworkCBB: Cord blood bankCBU: Cord blood unitCC: Collection centerCDC: Centers for Disease Control and PreventionCHTC: Certified Hematopoietic Transplant CoordinatorCIBMTR: Center for International Blood and Marrow Transplant ResearchCLL: Chronic lymphocytic leukemiaCML: Chronic myelogenous leukemia, chronic myeloid leukemiaCMV: CytomegalovirusCPI: Continuous Process ImprovementCRF: Comprehensive Report FormsCRM: Customer Relationship ManagementCT: Confirmatory (HLA) TestingCY: Calendar yearDC: Donor centerDNA: Deoxyribonucleic AcidDX: DiagnosisEBMT: European Society for Blood and Marrow TransplantationFA: Fanconi anemiaFACT: Foundation for the Accreditation of Cellular TherapyFMLA: Family and Medical Leave ActFSA: Flexible Spending AccountFY: Fiscal year


Page 92 of 95

GAO: U.S. Government Accountability OfficeGVHD: Graft-versus-host diseaseGVL: Graft versus leukemia, graft-versus-leukemia effectGVM: Graft versus malignancy, graft-versus-malignancy effectHCT: hematopoietic cell transplantHHS: (The Department of) Health and Human ServicesHIPAA: Health Insurance Portability and Accountability Act of 1996HIV/AIDS: human immunodeficiency virus/acquired immunodeficiency syndromeHLA: Human leukocyte antigenHRSA: Health Resources and Services AdministrationHTLV: human T-cell lymphotropic virusIDMs: infectious disease markersIRB: Institutional Review BoardIT: Information TechnologyMDS: Myelodysplastic syndromesMM: Multiple myelomaMPD: Myeloproliferative disorderNCI: National Cancer InstituteNHL: Non-Hodgkin lymphomaOHRP: Office for Human Research ProtectionsOHSRP: Office of Human Subjects Research ProtectionsOMB: Office of Management and BudgetOPA: Office of Patient Advocacy (used only in HRSA contract)PHPS: Patient and Health Professional ServicesPBSC: Peripheral blood stem cellRC: recruitment centerRITN: Radiation Injury Treatment NetworkSCD: Sickle cell diseaseSCTOD: Stem Cell Therapeutic Outcomes DatabaseSTAR: Search, Tracking and Registry (System)SCID: Severe combined immunodeficiency diseaseTC: Transplant centerTED: Transplant Essential DataTX: Transplant / treatment (avoid due to ambiguity)WHO: World Health OrganizationWMDA: World Marrow Donor Association



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Quick LinksCIBMTR and NMDP

AGNISBe The Match / National Marrow Donor Program Official WebsiteCIBMTR WebsiteTraining and ReferenceForms Instruction ManualClinical Research Professionals/Data Manager Conference MaterialsTraxisAdding/Removing Center PersonnelData Collection Forms ListRetired Forms ListHow to Look up Your CRC

Additional Resources:

Bone Marrow Donors WorldwideHRSA – Bone Marrow and Cord Blood Donation and TransplantationHHS – Informed ConsentBlood & Marrow Transplant Information NetworkFoundation for the Accreditation of Cellular TherapyGood Clinical PracticesLaboratory – Volume Unit ConverterLaboratory – GlobalRPh ConverterLymphomation.orgNational Cancer Institute



Page 94 of 95

http://agnis.net/

http://bethematch.org/

http://www.cibmtr.org/

http://www.cibmtr.org/DataManagement/TrainingReference/Pages/index.aspx

http://www.cibmtr.org/manuals/fim

https://www.cibmtr.org/Meetings/Materials/CRPDMC/Pages/2017CRPDM.aspx

https://connect.nmdp.org/

http://www.cibmtr.org/DataManagement/AdminResources/Personnel/pages/index.aspx

http://www.cibmtr.org/DataManagement/DataCollectionForms/Pages/index.aspx


http://www.surveygizmo.com/s3/1297998/Identify-your-CRC-by-Center

http://bmdw.org/

http://bloodcell.transplant.hrsa.gov/

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/index.html

http://bmtinfonet.org/

http://factwebsite.org/

https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090259.htm

http://www.unit-conversion.info/volume.html#data

http://globalrph.com/conv_si.htm

http://www.lymphomation.org/tests-immunoglobulins.htm

http://www.cancer.gov/

Contact Us• NMDP Service Desk at (612) 362-3411 or (800) 526-7809 Ext. 3411• [email protected]• [email protected]• Submit a question and/or issue into ServiceNow, our new customer service portal

◦ You can find the ServiceNow Reference Guide here



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https://www.cibmtr.org/DataManagement/ContactCRC/Documents/sn%20education%20transplant%20050319.pdf