APPLICATION FOR PARTICIPATION
AS AN AFFILIATE CENTER IN THE BMT CTN
Minimum qualifications are a “Yes” to one of questions # 9, 10, or 11.
BMT CTN Protocol #:
Protocol Title:
Center Name:
Center Address::
Date Submitted:
Submitted by:
Title:
Phone:
E-mail:
PI Name:
PI Phone:
PI Email:
PI Address:
CTEP Site Code if known:
This protocol is available on the BMT CTN public website at www.bmtctn.net. Please review the
protocol thoroughly before completing this application.
EMAIL COMPLETED APPLICATIONS TO BMT CTN DCC/EMMES AT bmtctnac@emmes.com
1. What is your projected annual patient accrual for this protocol?
2. Will your center be including pediatric patients?
Yes
No
3. Please complete the table on the next page to document your transplant center’s activity (note:
if you register your transplants with the CIBMTR, you do not need to complete this section but
you should check that your registration is up to date).
DCC USE ONLY:
The center will enroll through:
BMT CTN
SWOG/CTSU
CALGB/CTSU
ECOG/CTSU
Other_____________
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BMT CTN Affiliate Participation Form 12/2015
Twelve Month Period:
through
Month
Auto
Year
Month
HLA-id
Sibling
Other
Relative
Year
Unrelated
BM or PBSC
Unrelated
Cord Blood
AML
ALL
CML
CLL
MDS
Other Leukemia
MPS
Follicular NHL
Diffuse Large Cell NHL
Lymphoblastic NHL
Other NHL
Hodgkin Disease
Multiple Myeloma
Neuroblastoma
Breast Cancer
Other solid tumor
Aplastic Anemia
Immune Deficiency
Inborn Errors of Metabolism
Autoimmune Disease
Other, specify:
4. If your accrual projections exceed the past 12 month’s transplant activity, please explain.
5. Please list your staff whose job functions are transplant-related research.
Title
Total FTEs
Protocol Nurse
Regulatory Coordinator
Data Manager
Other, specify:
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BMT CTN Affiliate Participation Form 12/2015
6. Do you have active, IRB-approved protocols at your center that will compete against the
current protocol?
Yes
No
If yes, please justify your accrual projections:
7. Please estimate the time frame from approval for participation until first patient enrolled at
your center. Consider the time needed for contracting, training and IRB approvals.
8. How many active, IRB-approved transplant research protocols are currently open at your
center?
9. Is your center an NMDP participating center?
Yes
No
10. Is your center FACT accredited?
Yes
No
If no, have you completed an application for FACT accreditation?
Yes,
.
No
Date completed
11. Is your center an approved NCI Cooperative Group transplant center?
Yes
No
If yes, which Cooperative Group(s):
SWOG
Yes
No
CALGB
Yes
No
ECOG
Yes
No
COG
Yes
No
If yes, please check appropriate box(es) below:
Auto
Allo
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BMT CTN Affiliate Participation Form 12/2015
12. Is your center a CIBMTR participating center?
Yes
No
If yes, do you submit data on:
Allogeneic Transplants
Autologous Transplants
Please note: all CIBMTR participating centers must submit a Comprehensive Report Form (CRF) unless otherwise noted
for any patient participating in a BMT CTN trial regardless of your center’s status for CIBMTR data.
Do you agree to submit Comprehensive Report Form level data to the CIBMTR on all patients
enrolled in a BMT CTN trial AND TED level data for all patients transplanted at your center,
whether or not they are enrolled in a BMT CTN study, during the period you are actively
enrolling patients as an Affiliate Center?
Yes
No
A copy of CIBMTR data collection forms can be found at:
http://www.cibmtr.org/DataManagement/DataCollectionForms/index.html
13. Do you have a pharmacy that is able to receive, store and dispense investigational drugs and
maintain appropriate documentation?
Yes
No
14. Does your pharmacy charge a dispensing fee for investigational agents?
Yes
No
If yes, what is the fee for the following?
In-patient iv
In-patient oral
Out-patient iv
Out-patient oral
_ per dose
per dose
per prescription
per prescription
15. Does your center have the ability to process research specimens and appropriate freezer
(-70º C) storage?
Yes
No
16. Is your Radiotherapist Board-Certified?
Yes
No
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BMT CTN Affiliate Participation Form 12/2015
17. Can your radiation department perform fractioned TBI?
Yes
No
18. Is your radiation facility on-site or off-site?
On-site
Off-site
If off-site, please explain transportation arrangements
19. Has your center previously participated in BMT CTN protocols?
Yes
No
20. Does your center have high-speed Internet access (> T1 – 1.544 mbps)?
Yes
No
21. What is your principal Internet access platform? (please mark only one)
PC
MAC
Unix/Linux
22. Do you have Internet Explorer for Internet access?
Yes
No
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BMT CTN Affiliate Participation Form 12/2015