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. 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. 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. 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. 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 question 7. If the recipient’s country of primary residence is Canada, continue with question 8. If the recipient’s country of primary residence is the United States, continue with question 9. If the recipient’s country of primary residence is not Brazil, Canada, or the United States, continue with question 10.

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: Specify blood type: (for allogeneic HCTs only)

Indicate the recipient’s blood type as “A,” “B,” “AB,” or “O.” Blood type is an important characteristic in allogeneic transplant because products may require manipulation to minimize the risk of immune reaction due to incompatibility.

Question 13: Specify Rh factor: (for allogeneic HCTs only)

Indicate the recipient’s Rh (rhesus) factor. The Rh factor is an important characteristic in allogeneic transplant because product may require manipulation to minimize the risk of immune reaction due to incompatibility.

Question 14: Has the recipient signed an IRB / ethics committee (or similar body) – approved consent form for submitting research data to the NMDP / CIBMTR?

When a recipient consents to participate in the Observational Database, their data are contained in the CIBMTR’s Observational Database and used for research. The database includes recipient baseline and outcome data for related and unrelated allogeneic transplants from any cell source, and for autologous transplants. Data are also collected on unrelated donors and their donation experiences.

The primary purpose of the Observational Database is to have a comprehensive source of data that can be used to study hematopoietic cellular transplantation. Studies using these data include:

  • How well recipients recover from their transplants.
  • How recovery after transplantation can be improved.
  • What the long-term outcomes are after transplantation.
  • How access to transplantation for different groups of recipients can be improved.
  • How well donors recover from collection procedures.
  • The application and success of transplantation in the management of marrow-toxic injuries.

Indicate if the recipient has signed an IRB-approved consent form to participate in the Observational Database. If “yes (recipient consented),” continue with question 15. If “no (recipient declined)” or “not applicable (recipient not approached),” continue with question 17.

See the table below for additional information regarding how to report consent status for those with planned tandem or previous transplants.

Transplant Types Instructions
Tandem Autologous Transplants Most transplant centers would consider tandem autologous transplants as part of the same treatment plan and would consent the patient prior to the 1st HCT only. If that’s the case, the center should report “yes” to the consent question for the 2nd HCT and provide the date when the consent was first obtained.
Tandem Autologous-Allogeneic Transplants Most transplant centers would consider tandem autologous-allogeneic transplants as part of the same treatment plan and would consent the patient prior to the 1st HCT only. If the center has one IRB approved consent covering both the autologous and allogeneic transplants, then the center should report “yes” to the consent question for the 2nd HCT and provide the date when the consent was first obtained. In the case where a center has separate research database consents for autologous and allogeneic HCTs, the center should obtain both consents from the patient prior to the 1st HCT. The center should then report “yes” to the consent question for the 2nd HCT & provide the date when the consent was first obtained.
Autologous HCT followed by subsequent autologous HCTs (not a tandem autologous HCT) In this scenario, CIBMTR does not require an additional consent form to be signed. The only consent required would be the one obtained at the time of the first autologous HCT. The center should report “yes” to the consent question for the subsequent HCT and provide the date when the consent was first obtained. However, a center’s IRB may require a second database consent form to be signed in this situation, and centers should refer to the higher standard set by their IRB.
Allogeneic HCT followed by subsequent allogeneic HCTs (not a tandem allogeneic HCT) In this scenario, CIBMTR does not require an additional consent form to be signed. The only consent needed would be the one obtained at the time of the first allogeneic HCT. The center should report “yes” to the consent question for the subsequent HCT and provide the date when the consent was first obtained. However, a center’s IRB may require a second database consent form to be signed in this situation, and centers should refer to the higher standard set by their IRB.
Autologous HCT followed by subsequent allogeneic HCTs (not a tandem autologous HCT) If the center has one IRB approved consent form covering both autologous and allogeneic transplants, then the center should report “yes” to the consent question for the 2nd HCT and provide the date when the consent was first obtained. In the case where a center has separate research database consent forms for autologous and allogeneic HCTs, the patient would need to be re-approached prior to the subsequent allogeneic transplant and asked to sign the appropriate consent form. If the patient was not asked to sign a 2nd consent form, then “not approached” must to be reported on the Pre-TED.

Question 15: Did the recipient give permission to be directly contacted by CIBMTR for future research?

Indicate “yes (patient provided permission),” “no (patient declined),” or “not approached” if the recipient has given permission to be directly contacted by the NMDP / CIBMTR for future research as documented on the research database consent form and continue with question 16.

If “yes (patient provided permission),” is selected, the Recipient Contact Information (2820) form will also need to be completed.

Below is an example of this permission found in the NMDP/CIBMTR Research Database for Hematopoietic Cell Transplantation and Cellular Therapy Consent Form (Version 10.0).

Question 16: Date form was signed:

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

Question 17: Has the recipient signed an IRB / ethics committee (or similar body) – approved consent form to donate research blood samples to the NMDP / CIBMTR?

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 question 18. If “no (recipient declined),” “not approached,” or “not applicable (center not participating),” continue with question 21.

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 (patient consented).”

Question 18: 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 19-20: 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 ID in question 20. 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” and continue with question 21.

Question 21: Is the recipient participating in a clinical trial? (Clinical trials sponsors that uses CIBMTR forms to capture outcomes data)

Indicate if the recipient is a registered participant with BMT-CTN, RCI-BMT, USIDNET, COG, and/or another clinical trial sponsor that uses CIBMTR forms to capture outcomes data. If “yes,” continue with question 7. If “no,” continue with question 11.

Questions 22-23: 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,” “RCI-BMT,” or “PIDTC,” continue with question 24.

If the study sponsor is reported as “USIDNET” or “COG,” continue with question 25.

If “other sponsor” is reported, specify the study sponsor in question 23 and continue with question 25.

Question 24: Study ID Number

Select the recipient’s Study ID number.

Question 25: 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 an RCI-BMT study, enter the Subject ID given at the time of successful enrollment.

Last modified: Nov 23, 2020

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