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 |