Regulatory Documentation Standards

Data Transmission and IRB Documentation

CIBMTR cannot reimburse for Comprehensive Report Forms (CRFs) until it has a current, signed Data Transmission Agreement (DTA) or Master Healthcare Data (MHA) and Sample Submission Agreement is on file. The DTA or MHA permits centers (both US and International) to transfer patient data to CIBMTR for use in its research. Data Transmission Agreements are submitted to the NMDP Contracts department designees, who are assigned to specific centers.

Additionally, all US 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 CIBMTR.

Requirements:

1. NMDP (Contracts) must have an executed Data Transmission Agreement (DTA) or an updated Master Healthcare Data (MHA) and Sample Submission Agreement
2. CIBMTR must have current IRB documents (renewal letters and consents) including the following:
   • Current IRB documents
   • Approval letters
   • Approved consent forms
3. Renewal approval documentation submitted to CIBMTR must be received by the end of trimester
4. No patients consented during an approval lapse

*NOTE: if the center utilizes the NMDP IRB, then the above documents do not need to be sent to CIBMTR.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.