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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.
Policies:
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
- Written notification no later than 15 calendar days after knowledge of the adverse event
- Identify all safety reports previously filed concerning a similar adverse event
- Analyze the significance of the adverse event in light of previous similar reports
Fatal or life-threatening adverse drug experience
- Telephone or fax notification no later than 7 calendar days after knowledge of the adverse event
- Identify all safety reports previously filed concerning a similar adverse event
- Analyze the significance of the adverse event in light of previous similar reports
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 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.
Registration of studies with ClinicalTrials.gov
Clinical trials that evaluate the efficacy of drugs for serious or life-threatening diseases, and conducted under an Investigational New Drug application are mandated under the The Food and Drug Modernization Act of 1997 (FDAMA) to be registered to a central data bank.
In addition, the ICMJE is expanding the definition of the types of trials that must be registered to include preliminary trials, and adopts the World Health Organization's definition of a clinical trial which includes any intervention used to modify a biomedical or health-related outcome (examples include drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in subjects, including pharmacokinetic measures and adverse events. Observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not be required to register. The ICMJE member journals will implement the expanded definition for all trials that begin enrollment on or after July 1, 2008.
Clinicaltrials.gov provides information about a trial's purpose, eligibility, locations where studies are being conducted, and contact information. All federally funded trials should be posted. Failure to register studies prior to starting the study can seriously jeopardize the ability to publish or otherwise utilize the data due to policies of the International Association of Journal Editors. Please contact Arielle Black at 212-327-7709 or ablack@rockefeller.edu to have your trial registered.
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