1. Background
2. The RMIC Framework
3. RMIC Operational Groups
The CRDH is developing common data elements for cell characterization and data-sharing, web-based tools for data collection, clinical trial progress | tracking, and linkage of cell data to clinical data. It also provides support in overall management and coordination of all RMIC components.
The ICCH provides a robust infrastructure to conduct in-depth analyses of cell surface markers, multi-omics characteristics and other assays as appropriate.
The CRSC provides regulatory advice and assistance for manufacturing clinical-grade products. These services are provided through Production Assistance for Cellular Therapies (PACT).
Clinical Data and Specimen Repository
Cell characterization results, and if applicable, deidentified individual participant-level locked datasets will be shared to the broader research community via the RMIC through controlled access, as appropriate, in compliance with applicable Federal laws, regulations, and policies according to the following schedule:
- Cell characterization results will be shared one year following the end of RMIP awards
- Primary outcome clinical data will be shared one year following the primary completion date
- The full clinical dataset will be shared two years following the primary completion date
