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Regulatory Foundations, Ethics, and Law Program

Supporting researchers to navigate clinical and translational regulatory processes

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IND/IDE Consulting

Consultations offered include

  • IND and IDE Regulatory Requirements Education Services
  • Sponsor-Investigator IND and IDE Assistance

Eligibility

  • Investigators at Harvard Catalyst-participating schools or institutions and who currently hold an IND/IDE or are planning an IND/IDE study
  • Institutional officials responsible for the oversight of clinical & translational research
  • Hospital Institutional Review Boards or Committees at Harvard Catalyst-affiliated institutions

Cost

  • Free

Request Consultation 

The Harvard Catalyst Investigational New Drug and Investigational Device Exemption (IND/IDE) Consulting Service, composed of volunteer IND and IDE regulatory experts from the Harvard academic, medical, and hospital communities, offers expertise, resources, and shared experiences to assist Sponsor-Investigators in meeting regulatory requirements for their ongoing and/or new clinical and translational projects. The IND/IDE Consulting Service aims to help increase regulatory compliance and further development of innovative drugs, biologics, and medical devices with the support of Harvard Catalyst resources.

The IND/IDE Consulting Service focuses on providing assistance to researchers during the early stages of research development and maintenance of their INDs and IDEs. Please note that requests from eligible investigators from Mass General Brigham, Boston Children’s Hospital, and Dana-Farber Cancer Institute will be redirected to their institution’s designated IND contact. Upon submission of request for consultation, the affiliated hospital Institutional Review Board (IRB) will be notified of the investigator’s request for consultation and the final decision regarding INDs and IDEs is with the reviewing IRB.

 

Frequently Asked Questions:

1. What kinds of consultation services are available?

  • IND and IDE Regulatory Requirements Education Services
    • Overview of Sponsor-Investigator (IND/IDE holder) regulatory responsibility
    • Overview of record keeping requirements for Sponsor-Investigators
    • Overview of requirements for Clinicaltrials.gov registrations
    • Review of reporting requirements including safety reports and annual report
    • Review of federal regulations governing IND/IDE studies providing tools/checklists to ensure regulatory compliance
  • Sponsor-Investigator IND and IDE Assistance
    • IND and IDE applicability assessments
      • Identifying need for submitting an IND application
      • Identifying need for submitting an IDE application
    • Provide an overview of FDA IND/IDE application process

2. What kind of consultations are not available?

  • Assistance with submission of an IND or IDE application
  • Preparation, coordination, facilitation, or attendance at FDA meetings
  • Preparation for IRB applications
  • Preparation of FDA annual reports
  • Preparation for and regulatory support during FDA inspections of investigator sponsored clinical trials

3. What costs are associated with the consultation service?

Consultations are provided free of charge to Harvard Catalyst investigators, institute officials, and IRBs.

4. How do I request a consultation?

To initiate a consultation, please complete and submit the webform below. After your request is submitted, it will be reviewed by the consultation service and you will be contacted to arrange the details of the consultation. Please be advised that consultation is provided on a first-come, first-served basis. We recommend that you submit your request for a consultation as early as possible to allow for any scheduling delay.

IND/IDE Consulting Service Form

To request a Harvard Catalyst IND/IDE consultation, please complete and submit this form.