Table 1.

Institutional support for expanded access (n = 41)

Type of support	Support available	% of responses
Assistance with the Food and Drug Administration (FDA) submission	35	85
Assistance with the Institutional Review Board (IRB) submission	32	78
Development and preparation of the informed consent	29	71
Data collection requested by Expanded Access Program sponsors	11	27
Assistance with post-approval reporting requirements for FDA	24	59
Assistance with post-approval reporting requirements for IRB applications	16	39
Assistance with contracts with manufacturers	28	68
Assistance contacting manufacturers to make Expanded Access requests	22	54
Assistance creating a drug/device order and/or dispensing the investigational product	21	51
Research Pharmacy assistance for dispensing of investigational drugs	29	71
Assistance in clinical billing for the investigational product	19	46
Other support	8	20