PART V: Contracts Does your institution require indemnification and subject injury coverage in order to participate in an academic Investigator-Sponsored clinical trial? Yes No Does your institution require a fully executed contract and/or finalized budget before the initial IRB submission of the protocol? Yes No Please note: We cannot offer indemnification or subject injury compensation provisions for DF/HCC trials. If your institution has an internal process for granting a waiver, please describe it here. PART VI: Satellite Sites Please list any satellite locations, including their physical address and FWA number, that will participate in research for this protocol. Satellite locations do not typically require a separate approval. However, a location is considered a separate and distinct site by the DF/HCC if it meets ANY of the following criteria: Requires separate drug shipment; Requires monitoring at a separate location; Requires a separate contract; or Has different budgetary needs (e.g. additional startup fees) Has a separate IRB than the main institution If any of the above apply, you must submit a separate External Site Feasibility Questionnaire for each location. Investigator Declaration This form must be completed and returned to the DF/HCC Sponsor before the site can be considered for participation in the clinical trial. Name of Person Completing Form: Title/Role at the Site: **I certify that the information in this form is accurate to the best of my knowledge and that I take full responsibility for it as the Principal Investigator at this site. Principal Investigator Signature: __________________________________ Printed Name: Date: ________________________________________________ This section is for DF/HCC use only DF/HCC Sponsor Evaluation
PART V: Contracts Does your institution require indemnification and subject injury coverage in order to participate in an academic Investigator-Sponsored clinical trial? Yes No Does your institution require a fully executed contract and/or finalized budget before the initial IRB submission of the protocol? Yes No Please note: We cannot offer indemnification or subject injury compensation provisions for DF/HCC trials. If your institution has an internal process for granting a waiver, please describe it here. PART VI: Satellite Sites Please list any satellite locations, including their physical address and FWA number, that will participate in research for this protocol. Satellite locations do not typically require a separate approval. However, a location is considered a separate and distinct site by the DF/HCC if it meets ANY of the following criteria: Requires separate drug shipment; Requires monitoring at a separate location; Requires a separate contract; or Has different budgetary needs (e.g. additional startup fees) Has a separate IRB than the main institution If any of the above apply, you must submit a separate External Site Feasibility Questionnaire for each location. Investigator Declaration This form must be completed and returned to the DF/HCC Sponsor before the site can be considered for participation in the clinical trial. Name of Person Completing Form: Title/Role at the Site: **I certify that the information in this form is accurate to the best of my knowledge and that I take full responsibility for it as the Principal Investigator at this site. Principal Investigator Signature: __________________________________ Printed Name: Date: ________________________________________________ This section is for DF/HCC use only DF/HCC Sponsor Evaluation
DFHCC_External_Site_Feasbility_Questionnaire.docx