Program of IND/IDE Assistance (PIA)
Clinical Research Support Office
The purpose of PIA is to help sponsor-investigators become familiar with and comply with the requirements of investigator sponsored investigational new drug or device applications. This help is provided in several ways:
- Rapid access to guidance and regulations
- Assistance in filing and forms needed for an IND application
- Resources during the conduct of the trial
- Monitoring and oversight assistance
Site Directory
- Guidance
- FDA Requirements for Registration
- Filing and Forms
- Conduct and Oversight Services from Program of IND/IDE Assistance
- Review of submission prior to mailing
- Conduct of the IND Protocol
- Monitoring and Sponsor's Obligations
- Annual Reports and Amendments
- Adverse Events and Problems
- Quality Assurance/Audits
- Assistance Scheduling FDA Meetings
- Preparing for an FDA Audit
- FDA's IND Regulations
- Registration of trials with ClinicalTrials.gov
- Frequently Asked Questions about the IND Application Process
- Quick Links to Forms
Contact Us: IND Specialist/Monitor 212-327-7408 or Kimberly.Bazylewicz@rockefeller.edu
