CPI is comprised of several different data reporting metrics which will differ depending on the location of a center.
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. This is in addition to the center’s IRB approval for the CIBMTR research protocol and associated consent forms. 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
Consecutive Reporting of Hematopoietic Transplants Audit (CTA)
An annual review of CIBMTR-reportable transplants performed at each center over the past year, regardless of product origin. The list provided by each center ensures all transplants have been reported to the CIBMTR by comparing the center-provided list with CRID registration in FormsNet3. For details on this process, go to the Consecutive Transplant Audit (CTA) Standards page.
- Submit a complete list of all HCTs performed in the previous calendar year
- Register all HCTs performed in the prior calendar year, including subsequent transplants
- Resolve discrepancies (i.e. mismatches) found between center-provided lists and FormsNet3
- Resolve queries placed on forms with mismatched data
TED / CRF Form Submission
The CIBMTR monitors forms submission according to the designated CPI standards. Forms must be completed and error-free in FormsNet3.