Question 1: Ethnicity
The recipient’s ethnicity is automatically populated based on the value reported on the CRID Assignment Form 2804. Verify that the recipient’s ethnicity is correct. If an error is noted, correct Form 2804 and verify that the recipient’s ethnicity has been updated on the Pre-CTED Form 4000.
Question 2: Race: (check all that apply)
The recipient’s race is automatically populated based on the value reported on the CRID Assignment Form 2804. Verify that the recipient’s race is correct. If an error is noted, correct Form 2804 and verify that the recipient’s race has been updated on the Pre-CTED Form 4000.
Question 3: Has the recipient signed an IRB / Ethics Committee-approved consent form for submitting research data to the CIBMTR?
When a recipient consents to participate in the Observational Database, their data are available in the CIBMTR’s Observational Research Database and may be 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.
The primary purpose of the Observational Research Database is to have a comprehensive source of data that can be used to study hematopoietic cellular transplantation and cellular therapy. Studies using these data include:
- How well recipients recover from their infusions
- How recovery after infusion can be improved
- What the long-term outcomes are after transplantation and cellular therapies
- 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
- Cellular therapy
- Better understand new complications seen with infusion of certain cellular therapy products
- Compare outcomes of transplantation and cellular therapies between each other and to other therapies
Indicate if the recipient has signed an IRB-approved consent form to participate in the Observational Research Database. If “yes (patient consented),” continue with question 4. If “no” (patient declined)”, “not approached”, or “not applicable” (post-HCT scenario) continue with question 6. If the patient declines consent,or is not approached for consent, any data reported will not be used in observational studies.
Question 4: Did the recipient give permission to be directly contacted by CIBMTR for future research?
Indicate 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. If “yes (patient provided permission),” continue with question 5. If “no (patient declined)”, continue with question 6.
If “yes (patient provided permission),” is selected, the Recipient Contact Information Form (2820) 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 5: Date form was signed:
Report the date (YYYY-MM-DD) the research database consent form was signed by the recipient. Do not report the date that the witness or healthcare professional signed the consent form.
Question 6: Is the recipient participating in a cellular therapy clinical trial?
For the infusion being reported on this form, indicate if the recipient is a registered participant with BMT-CTN, RCI-BMT, USIDNET, COG, a Corporate / Industry trial, EudraCT, UMIN, an investigator initiated trial and/or another clinical trial sponsor, regardless if that sponsor uses CIBMTR forms to capture outcomes data. If “yes,” continue with question 7 to report the sponsor. If “no,” continue with question 13. If the participant is enrolled in multiple studies, even if from the same sponsor, report each study separately.
- BMT-CTN: Blood and Marrow Transplant Clinical Trials Network
- RCI-BMT: Resource for Clinical Investigation in Blood and Marrow Transplant
- USIDNET: United States Immunodeficiency Network
- COG: Children’s Oncology Group
- Corporate / Industry
- EudraCT: European Clinical Trials Database
- UMIN: University Hospital Medical Information Network Center
- Investigator initiated
Question 7 – 12: Study sponsor:
Select the study sponsor of the clinical trial the recipient is participating in. Click on the link above for more information about each organization.
If the study sponsor is reported as “BMT-CTN”, “RCI-BMT”, “USIDNET”, “COG”, or “Investigator initiated” in question 7, specify the ClinicalTrials.gov identification number in question 12. Investigator initiated trials include those that are initiated and managed by a non- pharmaceutical/company researcher (e.g. individual physicians or cooperative groups) and center specific trials or multi-center trials. Continue with question 15.
If the recipient is participating in corporate / industry sponsored trial, indicate the study sponsor as “Corporate/Industry” in question 7, specify the name of the Corporate or Industry sponsor in question 8 and report the clinicaltrials.gov ID number in question 12. Corporate/Industry examples include, but are not limited to, Atara Biotherapeutics, Bellicum Pharmaceuticals, BlueBird Bio, Celgene, Juno Therapeutics, Kite Pharma, Mesoblast, and Novartis. Continue with question 15.
If the recipient is participating in a European Medicines Agency clinical trial, indicate the study sponsor as “EudraCT” in question 7 and specify the Study identification number in question 9 (not the recipient ID). The European Union Drug Regulating Authorities Clinical Trials is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. See link for more information. The EudraCT number has the format YYYY-NNNNNN-CC, where YYYY is the year in which the number is issued, NNNNNN is a six digit sequential number, and CC is a check digit. Continue with question 13.
If the recipient is participating in a study with UMIN, indicate the study sponsor as “UMIN” in question 7 and specify the alpha-numeric study identification number in question 10 (not the recipient ID). UMIN was established in 1989 as a cooperative organization national medical school in Japan, sponsored by the Ministry of Education, Culture, Science, Sports and Technology (MEXT), Japan. Continue with question 13.
If the recipient is participating in a clinical trial and the study sponsor is not listed, select “other sponsor” in question 7, specify the sponsor name in question 11, and report the ClinicalTrials.gov identification number in question 12. Continue with question 15.
Question 13 – 14: Is the recipient receiving cellular therapy outside of the context of a clinical trial?
Indicate “yes” if the recipient is receiving cellular therapy in the setting:
Institutional guidelines/standard of treatment: Internal protocols at the center.
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.
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” and continue with question 15.
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