PROTOCOL TEMPLATE: OBSERVATIONAL STUDY Sections that are not applicable can be deleted. Complete Title: Short Title: Drug or Device Name(s): FDA IND/IDE (if applicable): Sponsor: Protocol Date: Amendment 1 Date: Amendment 2 Date: Amendment 3 Date: Amendment 4 Date: Sponsor (IND or IDE holder, if applicable) Sponsor Name Address City, Zip Country Study Principal Investigator (if multicenter study with UNC PI responsible) Office Address City, ST, ZIP Phone XXX-XXX-XXXX email: XXXXX@XXX.XXX
PROTOCOL TEMPLATE: OBSERVATIONAL STUDY Sections that are not applicable can be deleted. Complete Title: Short Title: Drug or Device Name(s): FDA IND/IDE (if applicable): Sponsor: Protocol Date: Amendment 1 Date: Amendment 2 Date: Amendment 3 Date: Amendment 4 Date: Sponsor (IND or IDE holder, if applicable) Sponsor Name Address City, Zip Country Study Principal Investigator (if multicenter study with UNC PI responsible) Office Address City, ST, ZIP Phone XXX-XXX-XXXX email: XXXXX@XXX.XXX
observational_protocol_template_unc_ch.docx