Clinical trial ....during a public health emergency
RFP-13-100-SOL-00008 Amendment 3 Apr 16
Offerors may be required to perform the following activities to prepare for a clinical trial during a public health emergency:
• Provide a plan that is ready to execute for the trial to include but not limited to personnel, documentation, regulatory approvals, material and management plans as appropriate
• Test the plan • Provide Clinical Protocol (CPs) • Provide Case Report Forms (CRFs) • Provide Informed Consent forms (ICFs) • Develop a clinical and safety database in preparation for Clinical database readiness • Pre-identify clinical research sites including study budget and contracts in place • Pre-qualify central laboratories for validated assays • Provide documented product delivery, storage and pharmaceutical product accountability
I guess if you're doing a clinical trial During a public health emergency SOL means S*@%% outa luck.
Cause you needed pre identified clinical sites and labs.