Table 1 Further information requested to support initial applications
| Domain | IERC 1 | IERC 2 | NDRA | NEC | NRC |
|---|---|---|---|---|---|
| Details of research procedures | X | X | X | X | |
| Details of informed/storage consent | X | X | X | ||
| Reimbursement | x | x | |||
| Details of research design | X | X | |||
| Pre-clinical data to justify human studies | X | ||||
| Details of adverse event monitoring | X | ||||
| Details of product standardization and quality | X | X | |||
| Adequacy of clinical trial site infrastructure | X | ||||
| Re-consenting of participants for specimen shipment | X |