Guidelines for Clinical Centers
Institutional Review Board Requirements
A program's investigational treatment protocols and patient consent forms should be reviewed and approved by an institutional review board that meets National Institutes of Health (NIH) criteria.
Data Management
- Each program should keep complete and accurate patient records that include the data coded in forms of the International Bone Marrow Transplant Registry (IBMTR) or the Autologous Bone Marrow Transplant Registry (ABMTR).
- It is recommended that each program provide clinical data to the IBMTR and ABMTR for outcomes analysis.
Transplant Review Process
Each program or center should have a written plan for Quality Assessment/Improvement that is monitored by the Director (and, ideally, involves all members of the transplant team).