Q1 – 21: Recipient Information

Question 1: Date of Birth

The date of birth is automatically populated based on the value reported in the CRID Assignment tool in FormsNet3. Verify that the date of birth is correct. If an error is noted, correct the CRID Assignment tool and verify that the date of birth has been updated on the Pre-TED Form.

Question 2: Sex

The recipient’s sex is automatically populated based on the value reported in the CRID Assignment tool in FormsNet3^SM. Verify that the recipient’s sex is correct. If an error is noted, correct the CRID Assignment tool and verify that the recipient’s sex has been updated on the Pre-TED Form.

Question 3: Ethnicity

The recipient’s ethnicity is automatically populated based on the value reported in the CRID Assignment tool in FormsNet3^SM. Verify that the recipient’s ethnicity is correct. If an error is noted, correct the CRID Assignment tool and verify that the recipient’s ethnicity has been updated on the Pre-TED Form.

Question 4: Race

The recipient’s race is automatically populated based on the value reported in the CRID Assignment tool in FormsNet3^SM. Verify that the recipient’s race is correct. If an error is noted, correct the CRID Assignment tool and verify that the recipient’s race has been updated on the Pre-TED Form.

Question 5: Race Detail

The recipient’s race detail is automatically populated based on the value reported in the CRID Assignment tool in FormsNet3^SM. Verify that the recipient’s race detail is correct. If an error is noted, correct the CRID Assignment tool and verify that the recipient’s race detail has been updated on the Pre-TED Form.

Question 6: Country of primary residence

Select the recipient’s country of residence.

• If the recipient’s country of primary residence is Brazil, continue with State of residence of recipient (for residents of Brazil).
• If the recipient’s country of primary residence is Canada, continue with Providence or territory of residence of recipient (for residents of Canada).
• If the recipient’s country of primary residence is the United States, continue with State of residence of recipient (for residents of USA).
• If the recipient’s country of primary residence is not Brazil, Canada, or the United States, continue with NMDP Recipient ID (RID).
  

Question 7: 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 at the time of transplant.

Question 8: Providence or territory of residence of recipients (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 at the time of transplant.

Question 9: State of residence of recipients (for residents of USA)

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

Question 10. NMDP Recipient ID (RID)

The NMDP RID is automatically populated based on the value reported on the CRID Assignment Form (2804). Verify that the NMDP RID is correct. If an error is noted, correct Form 2804 and verify that the NMDP RID has been updated on the Pre-TED Form.

Question 11: ZIP or postal code for place of recipient’s residence (USA recipients only)

Enter the five-digit ZIP code in which the recipient resides. Only five digits are required; however, if the ZIP+4 (nine digit) code is available, please report it in this field. The zip or postal code is required for USA residents.

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

Question 12: Has the recipient signed an IRB / ethics committee (or similar body) – approved consent form to donate research blood samples to the NMDP / CIBMTR? (for allogeneic HCTs only)

The Research Sample Repository contains blood samples from unrelated recipients and/or their adult volunteer donors or cord blood units. Related allogeneic recipients and/or donors will participate at selected transplant centers.

The primary objective of the Research Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cellular transplantation.

Studies in which these data may be used include

• Improving the understanding of tissue matching for hematopoietic cellular donors and recipients.
• Determining and evaluating the factors that affect transplant outcomes.
• Studying 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 matching between donors and recipients, including testing of rare HLA types).
  

Indicate if the recipient signed an IRB-approved consent form to donate research blood samples to the NMDP / CIBMTR. If Yes (recipient consented), continue with Date form signed. If No (recipient declined), Not approached, or *Not applicable (center not participating), continue with Is the recipient participating in a clinical trial.

Blood samples are not submitted for subsequent transplants; however, this question is asked for subsequent transplants. If the recipient previously consented to submit research blood samples to NMDP / CIBMTR, select Yes (recipient consented).

Question 13: Date form was signed

Report the date the research sample consent form was signed by the recipient. Do not report the date that the witness or health care professional signed the consent form.

Questions 14 – 15: Did the recipient submit a research sample to the NMDP / CIBMTR repository? (Related donors only)

There are a select number of transplant center participating in the Related Specimen Repository. If your center is one of the participating centers, and the recipient provided a research sample, select Yes and provide the recipient’s sample ID in Research sample recipient ID. The ID number is located on the bar code that is attached to the sample tube.

If the recipient did not provide a research sample, select No.

*Clinical Trials
As of the April 2023 release, and pre- or post-infusion key treatment clinical trials should now be reported on the Pre-TED (2400) Form, regardless of if the sponsor uses CIBMTR forms to capture outcomes data. Review the instructions below for additional information on key treatment clinical trials. Corporate / industry trials or investigator-initiated trials should be reported under Other.

!Therapy Clinical Trials
Do not report clinical trials for induction / consolidation / salvage therapy (excluding clinical trials sponsored by COG or if the recipient is enrolled on the PedAL study, COG APAL2020SC), blood / tissue sample collection, or any trial the recipient is enrolled post-HCT.

!Canadian Cancer Trials Group
Do not report Canadian Cancer Trials Group (CCTG) trials.

Question 16: Is the recipient participating in a clinical trial?

For the infusion being reported on this form, indicate if the recipient is a registered participant of a clinical trial regardless of if that sponsor uses CIBMTR forms to capture outcomes data. Only clinical trials relating to the HCT intervention and are known and consented at the time of HCT should be reported. This includes trials related to, but not limited to, the graft source, GVHD prophylaxis, or the preparative regimen.

Report any clinical trial, including upfront or relapse chemotherapy, only if the sponsor is COG or if the recipient is enrolled on the PedAL study, COG APAL2020SC.

Sponsors include but are not limited to, BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), USIDNET, COG, and PedAL. Report corporate / industry trials or investigator-initiated trials as an Other clinical trial sponsor.

• BMT-CTN: Blood and Marrow Transplant Clinical Trials Network
• CIBMTR CRO Services: Resource for Clinical Investigation in Blood and Marrow Transplant
• PIDTC: Primary Immune Deficiency Treatment Consortium
• USIDNET: United States Immunodeficiency Network
• COG: Children’s Oncology Group
• PedAL: LLS PedAL
• Other: Corporate / industry or investigator initiated

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

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

*Reporting Participation in More Than One Study
FormsNet3^SM application: Complete the Study Sponsor, Study ID Number, Subject ID, and 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.
Paper form submission: Copy the Study Sponsor, Study ID Number, Subject ID, and Specify the ClinicalTrials.gov identification number questions and complete for each study in which the recipient is participating.
If the participant is enrolled in multiple studies, even if from the same sponsor, report each study separately.

Questions 17 – 18: Study Sponsor

Select the study sponsor of the clinical trial the recipient is participating in. If the participant is enrolled in multiple studies, even if from the same sponsor, report each study separately.

If the study sponsor is reported as BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), or PIDTC, continue with Study ID Number.

If the study sponsor is reported as USIDNET, COG, or PedAL, continue with Subject ID.

If Other sponsor is reported, specify the study sponsor and continue with Subject ID.

Question 19: Study ID Number

Enter the BMT-CTN, RCI-BMT, or PIDTC study ID number of the recipient.

Although the RCI-BMT study sponsor name was updated to CIBMTR CRO Services, existing study ID options will remain listed as RCI-BMT. The new title CIBMTR CRO Services will be used as new studies are added to the option list.

Question 20: Subject ID

Enter the recipient’s USIDNET, COG, or Other sponsor subject ID.

If the recipient is participating in a BMT-CTN study and the EMMES ID is known, enter it here.

If the recipient is participating in a CIBMTR CRO Services (formerly RCI-BMT study), enter the Subject ID given at the time of successful enrollment.

Recipients enrolled in CIBMTR’s CMS studies should leave the subject ID blank.

Question 21: 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.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
Q16	7/19/2023	Add	Added the Canadian Cancer Trials Group red warning box: Canadian Cancer Trials Group Do not report Canadian Cancer Trials Group (CCTG) trials.	Updated for clarification
Q16	7/19/2023	Modify	Clarified which clinical trials should be reported: For the infusion being reported on this form, indicate if the recipient is a registered participant of a key treatment clinical trial pre or post infusion regardless of if that sponsor uses CIBMTR forms to capture outcomes data. Only clinical trials relating to the HCT intervention and are known and consented at the time of HCT should be reported. This includes trials related to, but not limited to, the graft source, GVHD prophylaxis, or the preparative regimen. Examples of pre-infusion key treatment clinical trials include cooperative group initial treatment trials (i.e., Alliance, ECOG-ACRIN, SWOG, and COG), cooperative group relapse treatment trials, and transplant trials. Report any clinical trial, including upfront or relapse chemotherapy, only if the sponsor is COG or if the recipient is enrolled on the PedAL study, COG APAL2020SC If the recipient is a registered participant of key treatment clinical trials and enrolled post-infusion, the Pre-TED (2400) should be updated to reflect the post-infusion trials. Examples of post-infusion key treatment clinical trials include the Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) and MAGIC consortium.	Updated for clarification
Q16	7/19/2023	Add	Therapy Clinical Trials red warning box added above Q16: Therapy Clinical Trials Do not report clinical trials for induction / consolidation / salvage therapy (excluding clinical trials sponsored by COG or if the recipient is enrolled on the PedAL study, COG APAL2020SC), blood / tissue sample collection, or any trial the recipient is enrolled post-HCT.	Added for clarification
Q16	7/19/2023	Modify	Clinical trials blue box updated above Q16: Clinical Trials As of the April 2023 release, pre or post infusion key treatment clinical trials regardless of if the sponsor uses CIBMTR forms to capture outcomes data should are now reported on the Pre-TED (2400) Form, regardless of if the sponsor uses CIBMTR forms to capture outcomes data. Review the instructions below for additional information on key treatment clinical trials. Corporate / industry trials or investigator-initiated trials should be reported under Other.	Updated for clarification
Q16	5/1/2023	Add	Clinical trials blue box added above Q16: Clinical Trials As of the April 2023 release, and pre- or post-infusion key treatment clinical trials should now be reported on the Pre-TED (2400) Form, regardless of if the sponsor uses CIBMTR forms to capture outcomes data. Review the instructions below for additional information on key treatment clinical trials. Corporate / industry trials or investigator-initiated trials should be reported under Other.	All key treatment clinical trials should now be reported as part of the Spring (April) 2023 quarterly release
Q16	5/1/2023	Modify	Instructions for reporting clinical trials updated as part of the Spring 2023 release: Indicate if the recipient is a registered participant of a key treatment clinical trial pre- or post-infusion. Examples of pre-infusion key treatment clinical trials include cooperative group initial treatment trials (i.e., Alliance, ECOG-ACRIN, SWOG, and COG), cooperative group relapse treatment trials, and transplant trials with BMT-CTN, RCI-BMT, USIDNET, COG, PedAL and/or another clinical trial sponsor that uses CIBMTR forms to capture outcomes data. If the recipient is a registered participant of key treatment clinical trials and enrolled post-infusion, the Pre-TED (2400) should be updated to reflect the post-infusion trials. Examples of post-infusion key treatment clinical trials include the Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) and MAGIC consortium. Sponsors include but are not limited to, BMT-CTN, RCI-BMT, USIDNET, COG, and PedAL. Report corporate / industry trials or investigator-initiated trials as an Other clinical trial sponsor. BMT-CTN: Blood and Marrow Transplant Clinical Trials Network RCI-BMT: Resource for Clinical Investigation in Blood and Marrow Transplant PIDTC: Primary Immune Deficiency Treatment Consortium USIDNET: United States Immunodeficiency Network COG: Children’s Oncology Group PedAL: LLS PedAL Other: Corporate / industry or investigator initiated The Other sponsor option should rarely be used. Do not report any transplant center specific clinical trials or investigator-initiated trials the recipient is participating at the transplant center. If the recipient is participating in a clinical trial but does not use CIBMTR form to capture outcomes data and does not fit in one of the specified options listed, contact CIBMTR Customer Support. If the recipient is not participating in a clinical trial, select No. Submit a ticket through CIBMTR Center Support when there are questions on reporting clinical trials.	All key treatment clinical trials should now be reported as part of the Spring (April) 2023 quarterly release
Q16	10/20/2022	Add	Instructions updated to include PedAL option: Indicate if the recipient is a registered participant with BMT-CTN, RCI-BMT, USIDNET, COG, PedAL and/or another clinical trial sponsor that uses CIBMTR forms to capture outcomes data. BMT-CTN: Blood and Marrow Transplant Clinical Trials Network RCI-BMT: Resource for Clinical Investigation in Blood and Marrow Transplant PIDTC: Primary Immune Deficiency Treatment Consortium USIDNET: United States Immunodeficiency Network COG: Children’s Oncology Group PedAL: LLS PedAL	Instructions missed in new manual version
Q17 – 18	7/28/2023	Modify	Updated instructions to clarify RCI-BMT is now known as CIBMTR CRO Services: Select the study sponsor of the clinical trial the recipient is participating in. If the participant is enrolled in multiple studies, even if from the same sponsor, report each study separately. If the study sponsor is reported as BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), or PIDTC, continue with Study ID Number.	Due to changes with Summer 2023 Quarterly Release
Q17 – 18	10/20/2022	Add	Instructions updated to include PedAL option: If the study sponsor is reported as USIDNET, COG, or PedAL continue with Subject ID.	Instructions missed in new manual version
Q19	7/28/2023	Add	Clarified response options will remain the same, even though the RCI-BMT has been updated to CIBMTR CRO Services: Enter the BMT-CTN, RCI-BMT, or PIDTC study ID number of the recipient. Although the RCI-BMT study sponsor name has been updated to CIBMTR CRO Services, existing study ID options will remain listed as RCI-BMT. The new title CIBMTR CRO Services will be used as new studies are added to the option list.	Instructions missed in new manual version

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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.