Three
complete sets of:
Forms from New Protocol Submission Packet
VA forms (if applicable)
ACH sign-off (if applicable)
Recruiting advertisement (if applicable)
Questionnaires/surveys (if applicable)
Investigator Brochure (if applicable)
Complete Protocol
Summary of Protocol
Consent formsPlus, 32 sets of everything but Investigator Brochure and
protocol.
This applies to all new submissions except "exempt" applications; only one
complete set is needed.
Instructions and forms from New Protocol Submission Packet
are available for download on the Forms and Guidelines page.
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