Determining the Need
for an IND
for an IND
Overview of IND Regulations
Investigator/Sponsor
Obligations
Obligations
Filing an IND
» Forms
» Documents
» IND Submission Process
Review of submission prior to mailing
Conduct of the IND Protocol
Monitoring and Sponsor's Obligations
Annual Reports and Amendments
Adverse Event Reporting Requirements
Quality Assurance/Audits
Assistance Scheduling FDA Meetings
Preparing for an FDA Audit
FDA's IND Regulations
Registration of trials with ClinicalTrials.gov
Form FDA 1571
Form FDA 1572
FDA Guidelines for completing forms 1571/1572
Medwatch Form
