A high-risk clinical trial is defined by the NIAID as having one or more of the following attributes:
- provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;
- administration of an unlicensed product; or
- administration of a licensed product for an unapproved indication.
Please see the link for more details:
The application due date is 13 September 2011.
Budgets are not limited, but must be realistic.