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Investigational New Drug (IND)
2.1 Determining if an IND Application is needed | 2.2 Compiling an IND Application | 2.3 IND Application approval Process | 2.4 Post-Approval | 2.5 IND Compliance with University of Minnesota Policy 2.1.10 | 2.6 FDA’s IND Rules and Regulations
An IND is an Investigational New Drug Application. It is a request to the FDA to allow the administration of investigational drugs to humans.
2.1 Determining if an IND Application is needed:
To determine if an IND Application is needed for your clinical research or study, ask yourself:
Will human subjects receive an unapproved drug?
Will human subjects receive an approved drug for an unapproved use?
If yes to either question then most likely an IND application is needed.
Dr. Harvey Arbit, Director of the IAP, can conduct a more detailed assessment of your research or study to determine if an IND is necessary.
In order for him to help you determine IND applicability certain information most be provided:
2.2. Compiling an IND Application
2.2.1 IND Application Format
The FDA has set forth a specific format an IND application must follow. The IAP will help in compiling an IND application if all the necessary documents are provided.
The necessary documents needed to compile an IND include:
-Form FDA-1571: The Investigational New Drug Application Form
-Form FDA-1572: The Statement of Investigator Form
-Cover Letter (cover letter template)
-Study Protocol: A written protocol describing the methodology to be used and an analysis of the protocol demonstrating its scientific soundness (Study Protocol template)
-Case Report Form: is a form used to collect various forms of data for your research (Case report template)
-Additional Documents needed to compile an IND
2.2.2 Submitting an IND Application
2.3. IND Application approval Process
-FDA will respond within 30 days with an acknowledgement letter and an IND number.
This means that the IND has been successfully filed, however, the clinical investigation can not start until 30 days after the IND has been received by the FDA, unless earlier notification by FDA is received, stating, that the studies may begin.
-After this acknowledgment the FDA may respond in one of two ways.
1. The FDA may request additional information and may place clinical holds on your study or research. The study cannot begin until all concerns raised by the FDA have been responded to satisfaction.
2. The FDA may conclude that your project is exempt. An exemption means that the study or research may be conducted without filing an IND application.
2.4. IND Post Approval
After approval of an IND, the Sponsor-Investigator is still subject to conditions set forth by the FDA and the University of Minnesota
The FDA has set forth responsibilities for the sponsor/investigator of clinical trials:
-Responsibilities of an IND sponsor-investigator.
-Conducting the study according to the most current approved protocol.
-Clinical monitoring must be conducted by a qualified individual and monitoring must be documented
CTMS Monitoring Plan
Investigator Self-Monitoring Plan
Clinical Monitoring Guidance Document for Sponsor-Investigators, (summary of FDA’s monitoring rules and regulations)
-Obtain informed consent
-The study protocol must be followed and if a change is made in the protocol, a protocol amendment must be sent to and approved by the FDA.
-Adverse events must be reported to the FDA.
-Annual progress reports must be sent to FDA
Annual report template
Information needed to meet the requirements of compiling an IND Annual Report to be submitted to the FDA.
Annual report transmittal letter template
-Maintain adequate record keeping of drug disposition
Drug disposition log template
-Maintain adequate data collecting forms (case report forms)
Case report form template
-Maintain adequate safety reports
Safety Report Templates
-Label all drug products with an investigational drug label
Investigational drug label template
-Permit inspection of the study records and reports by the FDA and the IND/DE assistance program. (bioresearch monitoring program: http://www.fda.gov/cdrh/comp/bimogen.html)
-FDA reporting obligations under an IND:
deadlines to submit documentation to the FDA under an IND
2.5 COMPLYING WITH University Policy 2.1.10
University Policy 2.1.10: This policy states that all University of Minnesota faculty members who file an IND/IDE with the FDA as a sponsor-investigator must submit all documents relevant to the IND/IDE to the central university documentation unit (IND/IDE Assistance Program).
IND Documents that should be sent to the IAP
In order to ensure compliance with University Policy 2.1.10 the IAP will conduct period reviews of your research records.
2.6. FDA’s IND Regulations
Title 21, Code of Federal Regulations, Part 312
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