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Initiated Clinical Research

Do you Need an IND? IND Applications and Maintenance

Investigational New Drug (IND)

What

An IND application is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug (or biological product) or an approved drug for a new indication or patient population. An IND is also a request for exemption from the federal stature which prohibits transport of an unapproved drug in interstate commerce.

Who

The FDA definition of a Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. (CFR 21 312.30 (b)) As per CFR 21 312.20 (a), the sponsor (sponsor-investigator) shall submit an IND to FDA if the sponsor (sponsor-investigator) intends to conduct a clinical investigation with an investigation new drug that is subject to CFR 312.2(a).

How

Use the IND Decision Worksheet to help determine if an IND application or an IND exemption submission to the FDA is required. Scroll down to Resources for additional reference tools. Detailed submission information can be found below. Pre-IND Consultation Program: The FDA offers a formal consultation program that can assist sponsors with questions related to drug development and IND submissions. Submitting New  Protocols to an Existing IND – New protocols using the same investigational drug may be submitted to an existing IND.  For more information, see IND Protocol Amendments or contact the FDA.

Questions

The Office of Research Services (ORS) provides IND consultation services as well as templates to assist study teams with Pre-IND, IND or IND exemption submissions. To view templates, please see them below under ‘Resources’. Please note that as of September 7, 2022 the ORS IND consultations services are temporarily unavailable.

The Clinical Research Support Unit (CRSU) at the The Tisch Cancer Institute (TCI) also provides IND consultations. For information regarding this service, please contact the TCI Clinical Research Team.

The Research Compliance Program provides regulatory guidance and education to research teams. For questions, contact Vivian.Mitropoulou@mountsinai.org or call (646) 605-7120.

Resources

IND Submission

Assistance

The Office of Research Services (ORS) provides consultation services as well as templates to assist study teams with Pre-IND, IND and IND Exemption submissions. Requests for assistance can be made through the ORS Ticketing System. Please note that as of September 7, 2022 the ORS IND consultations services are temporarily unavailable.

Clinical Research Support Unit (CRSU) provide IND consultations. To request a consultation, contact TCI Clinical Research Team.

IND Exemption Submissions

Investigators who believe the proposed research meets the exemption criteria outlined in 21 CFR 312.2b, should obtain confirmation from the FDA. FDA submissions must include a cover letter that clearly indicates the submission is an IND Exemption Determination Request. Please note, if a study involves several drugs in the same protocol, only one IND Exemption Determination Request application is required to be submitted.

The Office of Research Services (ORS) provides consultation services as well as application templates for IND submissions.  Requests for assistance can be made through the ORS Ticketing System. Please note that as of September 7, 2022 the ORS IND consultations services are temporarily unavailable.

Helpful Tips when Submitting

  1. Ensure that there is an MD on the protocol/study personnel.
  2. Ensure that the person who is administering the investigational agent is part of the protocol/study personnel and is credentialed to do so.
  3. Form 1571
    1. Name of Sponsor (Box 1): The investigator should be listed as the sponsor (MD/PhD).
    2. Telephone Number: The number listed should be a permanent number where the PI can be reached during working hours and messages are checked frequently.
    3. Countersigner Fields: These fields should be left blank.
  4. Application Template – If you are using the IND application templates, delete the instructions and format prior to submission.
  5. Make a copy of the submission and file it in the regulatory binder.

IRB and IND Submission Timelines

The IRB and FDA IND submission can be done in parallel. A copy of the FDA receipt of submission is required to be provided in the IRB submission.

Note: Studies cannot be initiated until the IND is in effect and IRB approval has been obtained.

FDA Submission

eCTD: For electronic IND submission to CDER see: https://www.fda.gov/drugs/forms-submission-requirements/electronic-regulatory-submission-and-review Note: This mode of submission is currently not mandatory, but is encouraged by the FDA The platform for electronic submission can be found HERE but you should review the information on the first link to learn about electronic submission and how to set up an account

CDER: For manual IND submission to the Center for Drug Evaluation and Research (CDER), see Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs).

CBER: For IND submissions to the Center for Biologics Evaluation and Research (CBER), please refer to the FDA guidelines outlined on Coronavirus (COVID-19) | CBER-Regulated Biologics.

IND Review Process

The FDA issues sponsor (sponsor-investigator) a letter that states the date of receipt of the IND application. The FDA will conduct a review within 30 calendar days of this date. For detailed information, refer to Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs).

Resources

FDA Coronavirus Treatment Acceleration Program (CTAP)

IND - Sponsor and Investigator Responsibilities (21 CFR 312 Subpart D)

Who

The FDA defines a sponsor-investigator as an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. (CFR 21 312.30 (b))

How

The sponsor-investigator must comply with FDA regulations applicable to both a sponsor and investigator. The sponsor and investigator responsibilities are outlined in the following FDA documents:

IND - Supplemental Documents

Resources

IND Reporting Requirements

IND Safety Reports (21 CFR 312.32)

IND sponsors must notify FDA and participating investigators 15 days of an incident in a written safety report of:

  • any adverse experience associated with the use of the drug that is both serious and unexpected or
  • any findings from tests in laboratory animals that suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity, and carcinogenicity.

For detailed guidance regarding the safety reporting requirements and submission process, refer to the FDA resources listed below.

ISMMS IRB Requirements

Reports are required to be submitted to the IRB within five business days. For guidance, refer to Form HRP – 224: Reportable New Information.

Questions

To request a assistance, please submit a Research 411 ticket.

Resources

IND Annual Reports (21 CFR 312.33)

IND sponsors (IND holders, sponsor- investigators) are required to submit annual reports to the FDA. These reports are due within 60 days of the anniversary date that the IND application went into effect. Note, this date is listed on the FDA Acknowledgement Letter.

Please find the template for your annual report here: IND Annual Report Template

If you are in need of a consultation to complete the IND Annual Report template, please contact Vivian Mitropoulou

Please note that Annual Reports are required even if there is no enrollment !

Questions

The Office of Research Services (ORS) provides annual report templates and guidance. To request assistance, please submit a Research 411 ticket.

Resources

IND Protocol Amendments (21 CFR 312.30)

IND sponsors (sponsor-investigator, IND holders) are expected to submit protocol amendments for new protocols or changes to existing protocols before implementation of the respective changes.

The IND sponsor (sponsor-investigator, IND holder) is responsible for notifying the FDA of the following:

  • New protocol
  • Change in protocol
  • New investigator

Refer to the FDA documentation below for guidance.

Questions

To request assistance, please submit a Research 411 ticket.

Resources

IND Information Amendments (21 CFR 312.31)

Information amendment is any amendment to an IND application with information essential to the investigational product that is not within the scope of protocol amendments, safety reports, or annual reports. For example, information amendments to IND applications may include:

  • new toxicology, chemistry, or other technical information; or
  • report regarding discontinuance of a clinical or non-clinical investigation

For detailed guidance regarding the reporting requirements and submission process, refer to the FDA resources listed below.

Questions

To request assistance, please submit a Research 411 ticket.

Resources

Significant FDA Communications Must be Reported to NIH

When NIH funds any part of the clinical study involving an IND or an IDE, significant communications with FDA must be reported to NIH.  For more information, refer to the NIH Policy Guidelines.

Regulatory Binder (Essential Documents)

For information regarding the regulatory binder requirements for FDA regulated sponsor-investigator studies, click here.

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