Q1-25: Recipient Data

Question 1: Country of primary residence

Select the recipient’s primary country of residence.

Question 2: State of residence of recipient (for residents of Brazil)

If Brazil was selected as the recipient’s primary country of residence, enter the recipient’s state of permanent residence.

Question 3: Province or territory of residence of recipient (for residents of Canada)

If Canada was selected as the recipient’s primary country of residence, enter the recipient’s providence or territory of permanent residence.

Question 4: State / territory of residence of recipient (for residence of USA)

If the United States was selected as the recipient’s primary country of residence, enter the recipient’s state of permanent residence.

Question 5: Zip or postal code for place of recipient’s residence (USA and Canada recipients only)

Enter the ZIP code in which the recipient resides. For USA residents, only five digits are required in the format of 12345; however, if the ZIP+4 (nine digit) code is available, report the nine-digit code as 12345-6789. For Canadian residents, report the six-digit code, which consists of both letters and numbers in the format of A1A 1A1.

The postal code is optional for Canadian residents. The question can be answered or left blank without error for Canadian residents.

Question 6: Does the recipient require interpreter services? (any interpreter for any level of care ex. reading / verbal)

The intent of this question is to determine care access, regardless of the language spoken. Indicate if the recipient requires interpreter services for any aspect of care, including verbal communication, reading, or other forms of assistance.

Question 7: Is the recipient an emancipated minor?

An emancipated minor is a person under the age of 18 who has been legally granted the rights and responsibilities of an adult. Indicate if the recipient was an emancipated minor at the start of the lymphodepleting therapy (or infusion if no lymphodepleting therapy was given).

Question 8: Specify the recipient’s current relationship status

Report the recipient’s relationship status at the start of the lymphodepleting therapy (or infusion if no lymphodepleting therapy was given).

• Single, never married: If the recipient has never been married and is not currently living with a partner.
• Married or living with a partner: If the recipient is currently married or living with a partner, regardless of whether the partnership is legally formalized.
• Separated / Divorced: If the recipient was married in the past but is now separated (legal separation is not required) or divorced.
• Widowed: If the recipient’s spouse passed away and is no longer married.

Question 9: What is the highest degree or level of school that the recipient has completed?

Select the option that best describes the recipient’s highest degree obtained / highest level of school completed at the start of the lymphodepleting therapy (or infusion if no lymphodepleting therapy was given). If the recipient has a GED, select Upper Secondary Education.

Question 10: Is the recipient covered by health insurance?

Indicate if the recipient is covered by any type of health insurance at the start of the lymphodepleting therapy (or infusion if no lymphodepleting therapy was given).

Questions 11 – 15: Specify type of health insurance (check all that apply)

Select the recipient’s health insurance coverage at the start of the lymphodepleting therapy (or infusion if no lymphodepleting therapy was given). Select all that apply.

• Private health insurance: Health insurance purchased by the recipient or recipient’s family, through an employer / union or an insurance company. Private health insurance includes ACA / Obamacare. If selected, specify the type of private insurance.
• National Health Insurance (Government-sponsored, non-U.S.): A government-sponsored, non-U.S. health insurance system covering the cost of healthcare for a country’s population. Examples include UK’s National Health Service and Australia’s Medicare system.
• Medicare (Government-sponsored, U.S., includes Medicare Advantage plans): A government-sponsored, U.S. health insurance program for anyone > 65 years, some people < 65 years old with certain conditions / disabilities, and those with end stage renal disease. If selected, specify the type of Medicare.
• Medigap (Must have Medicare coverage): Also known as Medicare Supplement Insurance. If already covered by Medicare, additional health insurance may be purchased from a private insurance company to cover additional out-of-pocket costs.
• Medicaid (Government-sponsored, U.S.): A government-sponsored, U.S. health insurance program providing coverage for those with limited income.
• Children’s Health Insurance Program (CHIP): Health insurance coverage provided for children whose family does not qualify for Medicaid.
• Military-related health care (TRICARE (CHAMPUS) / VA health care / CHAMP-VA): Military-related health care provided by the Department of Defense or the Department of Veterans Affairs.
• Indian Health Service: A federal agency within the Department of Health and Human Services providing health care to American Indians and Alaska Natives.
• State-sponsored health plan: Health insurance program funded by both state and federal governments. Currently, there are three such programs: MinnesotaCare, Basic Health Program (NY), and Oregon Health Plan Bridge Program.
• Disability insurance: A type of insurance that replaces a portion of lost income for those who are unable to work due to illness or injury. Disability insurance may be available through an employer, the government, or private insurance.
• Other government program: If the recipient’s health insurance coverage is a government-sponsored but not listed above, specify the type of government program health insurance.
• Other health insurance coverage: If the recipient’s health insurance coverage is not government-sponsored and not listed above, specify the type of coverage.

Question 16: Was this infusion received within the context of a clinical trial?

For the infusion being reported on this form, indicate if the recipient is a registered participant of a clinical trial, regardless if that sponsor uses CIBMTR forms to capture outcomes data. Only clinical trials relating to the infusion intervention and are known and consented at the time of infusion should be reported

If the recipient is not participating in a clinical trial or it is unknown, select No.

Submit a ticket through CIBMTR Center Support when there are questions on reporting clinical trials.

!Participation in Multiple Clinical Trials
If the participant is enrolled in multiple studies, even if from the same sponsor, report each study separately.

*Reporting Participation in More Than One Study
Complete the Sponsor through Specify the ClinicalTrials.gov identification number questions for each study the recipient is participating in by adding an additional instance in the FormsNet3^SM application.

*Commercially available products
Refer to the product specific reporting guides available on the CIBMTR Portal for additional instruction on when to report a clinical trial.

Questions 17 – 22: Sponsor
Select the study sponsor of the clinical trial the recipient is participating in from the list below.

• ANZCTR: Australian New Zealand Clinical Trials Registry EudraCT: European Clinical Trials Database
• BMT-CTN: Blood and Marrow Transplant Clinical Trials Network
• CIBMTR CRO Services: CIBMTR Clinical Research Organization Services
• COG: Children’s Oncology Group
• EudraCT: European Clinical Trials Database
• PTCTC: Pediatric Transplantation & Cellular Therapy Consortium
• SWOG: SWOG Cancer Research Network
• UMIN: University Hospital Medical Information Network Center
• USIDNET: United States Immunodeficiency Network
• Corporate / Industry
• Investigator initiated
• Other sponsor: If selected, specify the sponsor.

Question 23: Specify the ClinicalTrials.gov identification number

All clinical trials are required to be registered on the clinicaltrials.gov website and will have an associated identification number.

Report the identification number. Do not include the letters “NCT,” preceding the digits.

Questions 24 -25: Was this infusion received outside the context of a clinical trial?

This question is not applicable if the infusion is received within the context of a clinical trial.
Indicate Yes if the recipient is receiving cellular therapy outside of the context of a clinical trial and in one of the following settings:

• Institutional guidelines/standard of treatment: Internal protocols at the center.

*Select Institutional guidelines/standard of treatment if the product is the commercially available product Abecma®, Amtagvi®, Aucatzyl®, Breyanzi®, Carvykti®, Kymriah®, Yescarta®, Tecartus®, or Tecelra®

• Hospital exemption: Applicable when giving cell therapy product without a clinical trial, the hospital that produces the cells must be the hospital that gives the cells.

*Out of spec products
Refer to the product specific reporting guides available on the CIBMTR Portal for additional instruction for out of spec/non-conforming commercially available products.

• Compassionate use: No protocol is available or approved by institution, the physician asks for a one- time use.

If the recipient is not receiving the cellular therapy outside the context of a clinical trial, select No.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.