Data Transmission and IRB Documentation
The CIBMTR cannot reimburse for CRFs until it has a current, signed Data Transmission Agreement (DTA) or Master Healthcare Data and Sample Submission Agreement (MHA) on file. The DTA or MHA permits centers (both US and non-US) to transfer patient data to the CIBMTR for use in its research. Data Transmission Agreements are submitted to the NMDP/Be The Match Contracts department designees, who are assigned to specific centers.
Additionally, all U.S. centers must obtain IRB approval for both the “Protocol for a Research Database for Hematopoietic Stem Cell Transplantation, other Cellular Therapies, and Marrow Toxic Injuries” and “Protocol for a Research Sample Repository for Allogeneic Stem Cell Transplantation, Other Cellular Therapies, and Marrow Toxic Injuries”. Upon obtaining IRB approval, the center must send a copy of the IRB’s approval letter, approved protocols, and informed consent documents to the CIBMTR.
a. The NMDP (Contracts) must have an executed Data Transmission Agreement (DTA) or an updated Master Healthcare Data and Sample Submission Agreement (MHA)
b. The CIBMTR must have current IRB documents (renewal letters and consents) including the following:
- Current IRB documents
- Approval letters
- Approved consent forms
c. Renewal approval documentation submitted to CIBMTR must be received by the end of trimester.
d. No patients consented during an approval lapse.