The Rockefeller University - Program of IND/IDE Assistance (PIA)

Determining the Need
for an IND

Overview of IND Regulations

Investigator/Sponsor
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

Friday, August 29, 2008




Advanced Search

Program of IND/IDE Assistance (PIA)


	PIA Home
	Guidance »
	Filing and Forms »
	Conduct and Oversight Services from Program of IND/IDE Assistance »
	FAQ's about the IND Application Process
	Quick Links to Forms »

Printer-Friendly Version

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* Determining the Need for an IND Overview of IND Regulations Investigator/Sponsor Obligations *Filing and Forms* Filing an IND Forms Documents IND Submission Process *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 kbazylewic@rockefeller.edu