Conduct and Oversight Services from Program of IND/IDE Assistance

Review of submission prior to mailing

If you need assistance with completing the IND package, or would like your submission reviewed prior to mailing, the IND Specialist, can conduct a review and answer any questions.

Conduct of the IND Protocol

Investigator-sponsor studies must adhere to federal guidelines for conduct and oversight of the trial. Assistance can be provided to ensure the proper process is in place and that the proper documentation is be created for your trial. Some of the services which can be provided by the IND specialist include a pre-start up meeting to review documentation practices, reviewing expectations and processes for monitoring, or maintaining regulatory documents for the IND.

Monitoring and Sponsor's Obligations

The Clinical Research Support Office offers a monitoring program to assist sponsor- investigators with the monitoring requirements under 21 CFR 312. If you would like your trial monitored, please contact the IND Specialist/Monitor at 212-327-7408.

Annual Reports and Amendments

The FDA requires Annual Reports for active INDs. Annual Reports should be submitted to the FDA within 60 days from the anniversary date of the original IND, in each successive year. The Clinical Research Support Office will provide reminders prior to this date to ensure all Annual Reports are submitted to FDA in a timely manner.

Amendments to protocols must be reported to the FDA as they are proposed and IRB approved. New versions of forms 1571 and 1572 must be submitted to the FDA with amendments.

Adverse Event Reporting Requirements

To submit an adverse event for an IND, use Form FDA 3500A, Medwatch Mandatory Reporting Form.

The reporting requirements for IND studies are listed below. Please also note the additional IRB reporting requirements at http://clinfo.rockefeller.edu/irb/.

   Serious or Unexpected adverse drug experience

   Fatal or life-threatening adverse drug experience

Click here for additional explanations of adverse events.

Quality Assurance/Audits

In addition to monitoring services provided by the office, the IND specialist conducts periodic not-for-cause audits of ongoing INDs to assist investigators in assuring and strengthening their programs. Audits can also be requested directly by the investigator for quality assurance and quality improvement purposes. All studies will be subject to periodic audits.

Assistance Scheduling FDA Meetings

The Clinical Research Support Office can assist you with any with any needs that may arise in corresponding or talking with the FDA.

Preparing for an FDA Audit

Investigators and sponsors are obligated to allow the FDA to inspect the conduct and documentation of the research at any time (21 CFR 312.58; 312.68) The FDA periodically chooses investigators, or protocols for not-for-cause audits. The FDA may also perform a for-cause inspection. If your trial has been chosen for an FDA inspection, please contact the Clinical Research Support office to assist you with audit preparation.

FDA's IND and IDE Regulations

Regulations are federal laws and enforceable as such. The regulations governing FDA regulated research are contained in Title 21, Code of Federal Regulations, Part 312. In addition, the FDA provides guidance on some but not all topics. Guidances are not laws but generally indicate the intention and interpretation of the regulations.



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Contact Us: IND Specialist/Monitor 212-327-7408 or Kimberly.Bazylewicz@rockefeller.edu