Summary: This form is required for each IND submission and is viewed as a “cover page”. It collects information on which IND the submission is for as well as what is included in the submission. This form also lists the commitments made by the sponsor-investigator as the IND sponsor.
Summary: This form is a contractual agreement between the Investigator and the Sponsor. It is also required to be submitted for a sponsor-investigator. The purpose of this form is to collect information on who the person responsible for conducting the study will be and their credentials as well as information on the location and resources to be used at the clinical study site. This form is submitted initially for each investigator and is only required to be resubmitted when the information on the form needs to be updated.
Summary: This form collects information regarding registration of your protocol on clinicaltrials.gov. This form is submitted initially to declare whether or not your study is considered to be an Applicable Clinical Trial (ACT) and if so, for you to provide the National Clinical Trial (NCT) number created when the trial is registered with clinicaltrials.gov. This form only needs to be submitted once.
Additional regulatory templates are available on Duke ORAQ's Regulatory Resources web page.