3C Infectious Disease Markers - 2004 R5 (current approved f

Stem Cell Therapeutic Outcomes Database

FORM 3C - 2004 R5 (current approved for)

Product Form (Includes Infusion, HLA, and Infectious Disease Marker Inserts)

OMB: 0915-0310

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Infectious Disease Markers

OMB No: 0915-0310
Expiration Date: 10/31/2022

Registry Use Only
Sequence Number:

Public Burden Statement: An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a currently valid
OMB control number. The OMB control number for this project is 0915-0310.
Public reporting burden for this collection of information is estimated to average 1
hour Public reporting burden for this collection of information, in combination with the
HLA Typing Form 2005 and HCT Infusion Form 2006, is estimated to average 1 hour
per response, including the time for reviewing instructions, searching existing data
sources, and completing and reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to HRSA Reports Clearance Officer,
5600 Fishers Lane, Room 14N39, Rockville, Maryland, 20857.

Date Received:

CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Event date: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	
HCT type (check all that apply):	

☐ Allogeneic, unrelated	

☐ Allogeneic, related

Product type (check all that apply):	

☐ Bone marrow	

☐ PBSC	

☐ Single cord blood unit	

☐ Multiple cord blood units 	 ☐ Other product. Specify:___________________

Product Identifiers:
Registry donor ID: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __
Non-NMDP cord blood unit ID: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __
GRID: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __
ISBT DIN: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __
Registry or UCB Bank ID: __ __ __ __
Donor DOB: __ __ __ __ / __ __ / __ __
YYYY	 MM	DD
Donor Age: __ __ 	 ☐ Months (use only if less than 1 year old)	
Donor Sex: ☐ Male 	

☐ Years

☐ Female

CIBMTR Form 2004 revision 5 (page 1 of 4). Form released January, 2020. Last Updated January, 2021.
Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

This form must be completed for all non-NMDP allogeneic or syngeneic donors, or non-NMDP cord blood units.
Donor/Cord Blood Unit Identification
1.

Who is being tested for IDMs?

☐ Donor IDM (marrow or PBSC)
☐ Maternal IDM (cord blood)
☐ Cord blood unit IDM

Infectious Disease Marker (report final test results)
Hepatitus B Virus (HBV)
2.

4.

6.

HBsAg (hepatitus B surface antigen)

☐ Reactive
☐ Non-reactive
☐ Not done

3.

Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

5.

Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD

7.

Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD

9.

Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD

Anti HBc (hepatitus B core antibody)

☐ Reactive
☐ Non-reactive
☐ Not done

FDA licensed NAAT testing for HBV

☐ Positive
☐ Negative
☐ Not done

Hepatitis C Virus (HCV)
8.

Anti-HCV (hepatitis C antibody)

☐ Reactive
☐ Non-reactive
☐ Not done

10. FDA licensed NAAT testing for HCV

☐ Positive
☐ Negative
☐ Not done

11. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD

Human Immunodeficiency Virus (HIV)
12. HIV-1 p24 antigen

☐ Reactive
☐ Non-reactive
☐ Not done
☐ Not reported

13. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

CIBMTR Form 2004 revision 5 (page 2 of 4). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2021.
Last Updated January, 2020. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

14. FDA licensed NAAT testing for HIV-1

☐ Positive
☐ Negative
☐ Not done

15.

Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

16. Anti-HIV 1 and anti-HIV 2* (antibodies to Human Immunodeficiency Viruses)
* Testing for both HIV antibodies is required. This testing may be performed as separate tests or done using a combined assay.

☐ Reactive
☐ Non-reactive
☐ Not done
☐ Not reported

17. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

Chagas
18. Chagas testing

☐ Positive
☐ Negative
☐ Not done

19. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

Herpes simplex virus (HSV)	
20. Anti-HSV (Herpes simplex virus antibody)

☐ Positive
☐ Negative
☐ Not done

21. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

Epstein-Barr virus (EBV)	
22. Anti-EBV (Epstein-Barr virus antibody)

☐ Positive
☐ Negative
☐ Inconclusive
☐ Not done

23. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

Varicella zoster virus (VZV)	
24. Anti-VZV (Varicella zoster virus antibody)

☐ Positive
☐ Negative
☐ Not done

25. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

CIBMTR Form 2004 revision 5 (page 3 of 4). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2021.
Last Updated January, 2020. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Other Infectious Disease Marker	
26. Other infectious disease marker, specify

☐ Yes
☐ No

27. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	
28. Specify test and method:________________________________________________________
29. Specify test results: ____________________________________________________________
Copy questions 27 - 29 to report multiple other infectious disease markers

First Name (person completing form):__________________________________________
Last Name:_______________________________________________________________
E-mail address:___________________________________________________________
Date: __ __ __ __ / __ __ / __ __
YYYY
MM
DD

CIBMTR Form 2004 revision 5 (page 4 of 4). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2021.
Last Updated January, 2020. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.


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