Reporting Sponsor-Investigator IND/IDE and FDA Pre-Submissions
The University has accountability obligations for all sponsor-investigator drug, device, or biological research at the University. The primary objective is to promote compliance with Food and Drug Administration (FDA) Investigational New Drug Application (IND) and Investigational Device Exemption (IDE) regulations.
Faculty members who request or receive FDA feedback on pre-FDA submissions for a sponsor-investigator IND or IDE, or who file an IND or IDE with the FDA as a sponsor-investigator, must submit copies of all documents relevant to the FDA pre-submission and IND/IDE to the IND/IDE Central File. The required documentation copies include:
- The application
- Safety reports
- Communications, including transcriptions of calls with the FDA
- Annual report(s)
Sponsor-investigators are responsible for compliance with FDA reporting requirements. Units must send copies of the FDA related documents to the IND/IDE Central File as they are received or sent.
If sponsor-investigators fail to comply with FDA regulations, the IND/IDE Central File personnel will notify appropriate institutional leaders and groups including but not limited to the Vice President for Research, department head and dean.
This reporting policy does not apply to the more common situation when a faculty member serves only as the principal investigator on an IND or IDE, whose sponsor is an outside company, institution, organization, or individual. Under federal law, the outside sponsor, not the University, is responsible for interactions with the FDA. The principal investigator, however, remains subject to all other University policies on clinical research.
REASON FOR POLICY
This policy promotes compliance with FDA regulations in sponsor-investigator initiated drug, device and biologics studies at the University of Minnesota The FDA will not directly communicate with the University regarding a sponsor-investigator's pre-submission, IND or IDE interactions. The University, however, is potentially liable for the actions of its faculty members. The requirement for sponsor-investigators to submit copies to the University-wide repository (Central File) will enable the University to monitor the completeness and timeliness of IND/IDE and FDA pre-submission reporting and to respond to inquiries.
This policy also promotes the availability of services to assist sponsor-investigators in interpreting FDA regulations and changes, and communicating with the FDA.
- Food and Drug Administration (FDA)
- The regulatory authority in the United States which oversees various industries, including pharmaceutical and medical device industries.
- IND/IDE Regulatory Director
- A role of the Human Research Protection Program, under the supervision of the Vice President for Research (OVPR), to ensure subjects protections under sponsor-investigator IND/IDE.
- Investigational Device Exemption (IDE)
- FDA regulation to allow for the conduct of a clinical study using a device that is new or not used in accordance with the approved labeling. IDE also refers to documentation submitted to and received from the FDA regarding an IDE for significant risk devices.
- Investigational new drug application (IND)
- FDA regulation to allow for the conduct of a clinical study using a drug or a biological product that is new or not used in accordance with the approved labeling. IND application refers to documentation and correspondence submitted and received from the FDA regarding an IND.
- Investigator is an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the investigational device, biologic or drug is administered, dispensed to, or used involving a subject. In the event of an investigation being conducted by a team of individuals, "investigator" refers to the responsible leader of that team.
- An individual, company, institution, or organization that takes responsibility for and initiates a clinical study, but does not conduct an investigation.
- Sponsor-investigator is an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the investigational device, biologic or drug is administered, dispensed, or used. The term does not, for example, include a corporation or agency. The obligations of a sponsor-investigator include those of an investigator and those of a sponsor.
- Pre-FDA Submission for IND/IDE
- A process to establish an IND/IDE. Also refers to documentation and correspondence submitted to and received from the FDA.
- Submit copies of all relevant documents (pre-FDA submission, IND/IDE application, all communications to and from the FDA, safety reports, initial protocol, protocol amendments, and annual reports) to the IND/IDE Central File. Verbal communications with the FDA should be transcribed and filed with the Central File.
- IND/IDE Regulatory Director
- Provide free, optional assistance to faculty members who are seeking FDA pre-submission guidance, preparing an IND or IDE to the FDA or need guidance as to whether an IND or IDE is required. The IND/IDE Regulatory Director will operate the IND/IDE Central File as an obligatory requirement for all sponsor-investigators of an IND/IDE or a pre-IND/IDE. Report suspected or known instances of noncompliance with University, FDA, or other applicable policies to the appropriate institutional leaders and groups, including but not limited to the Vice President for Research, department head and dean.
- IND/IDE Central File personnel
- Maintain a central file (copies) of all documents relevant to a sponsor-investigator pre-IND/IDE or IND/IDE held by a faculty member.
- July 2015 - Comprehensive Review. Major Revision. Reflects the change of the documentation unit to IND/IDE Central File. Includes a requirement to provide transcripts of conversations with the FDA.
- November 2003