An Investigational New Drug (IND) Application is submitted to U.S. Food and Drug Administration (FDA) if a drug not previously authorized for marketing in the US is intended to be used for the purposes of clinical investigation.
A clinical investigation is defined by the FDA as “an experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. Such an experiment is any use of a drug [whether approved or unapproved] except for the use of a marketed drug in the course of medical practice."
The Sponsor of an IND application is the party who submits the application to FDA. In the absence of any other sponsor (e.g. pharmaceutical company), the investigator conducting the proposed clinical investigation is the sponsor of the IND application.
When developing new drugs and devices in pre-clinical research to the point where they transition to investigations clinical applications, FDA approval is required and the Principal Investigator for the research serves as the Sponsor of the IND unless or until the further development and/or commercialization of the new drug or device is undertaken by a third party.
Consistency with Georgia Tech’s Strategic Plan, Other Institute Policies, and Related External Documents
21 CFR 11 (Electronic records and electronic signature)
21 CFR 54 (Financial Disclosure by Clinical Investigators) [FDA forms 3454 and 3455]
21 CFR 210 (Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding of Drugs; General)
21 CFR 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)
21 CFR 312 (Investigational New Drug Application)
21 CFR 314 (Drugs for Human Use)
21 CFR 320 (Bioavailability and Bioequivalence Requirements)
21 CFR 330 (Over-The-Counter (OTC) Human Drugs Which are Generally Recognized as Safe and effective and Not Misbranded)
21 CFR 601 (Biologics Licensing)
The Principal Investigator for the project under which a new drug may become the subject of a clinical investigation and who is responsible for the initiation and conduct of the clinical investigation shall be responsible for developing the IND Application to be submitted to the FDA and will be a “Sponsor-Investigator” in accordance with 21CFR§312.53. Usually, the intent of the research in such a clinical investigation is to gain scientific knowledge without seeking market approval for the drug or device. This responsibility is generally part of the Principal Investigator’s research duties when it takes place in the course of sponsored or Institute-funded research. The Sponsor-Investigator is the source of the information for the relevant FDA filings and reports and is responsible for their content.
The Sponsor-Investigator’s responsibilities include:
- Selecting clinical investigators. Clinical investigations must be conducted in appropriate clinical setting under the direction of a physician (or dentist, when appropriate) qualified by training and experience as appropriate experts to investigate the drug who should be listed as a Sub-investigator for the trial and should be responsible for all trial-related medical (or dental) decisions. Clinical investigations will generally be conducted pursuant to an appropriate contract or subcontract with a Clinical Research Organization (CRO), most often an academic medical center, with the Sub-investigator generally serving as its Principal Investigator. The negotiation and awarding of the contract or subcontract will follow all applicable Institute policies, guidelines, and applicable regulations.
- Selecting a Contract Manufacturing Organization (CMO) or other source to provide the drug for use in the study in compliance with applicable FDA requirements. The negotiation and awarding of the contract with the CMO or supplier will follow all applicable Institute policies, guidelines, and applicable regulations.
- Informing and qualifying investigators by obtaining their commitment to supervise the study, follow the protocol, and obtain consent.
- Monitoring the conduct of the study by auditing documentation and conducting site visits.
- Completing regulatory filings related to the IND or IDE, adverse events, amendments or revisions, progress reports, withdrawal of IRB approval, and final reports.
- Controlling the distribution, tracking, and dispensation of the regulated products.
Sub-investigator (Principal Investigator for Clinical Contract or Clinical Subcontract) Responsibilities Include:
- Ensuring IRB approval for the study is obtained before any subjects are enrolled.
- Ensuring that informed consent is obtained in accordance with FDA regulations.
- Ensuring that the investigation is conducted according to the investigational plan and applicable regulations.
- Administering the drug or using the device only in subjects under the investigator's supervision or under the supervision of a recognized sub-investigator.
- Maintaining adequate records of the dispensation of the drug or device.
- Returning unused materials at the end of trial.
- Preparing and maintaining adequate case histories and signed informed consent documents.
- Maintaining correspondence with the IRB and the sponsor to make sure that both have reviewed protocol amendments, recruitment materials, investigator brochures.
- Retaining records in accordance with regulations.
- Providing progress, safety, final and financial disclosure reports.
- Notifying the sponsor if IRB approval is withdrawn.
- Comply with International Conference on Harmonisation (ICH) guidelines, if applicable. Please see the module International Conference on Harmonisation, ICH for Investigators.
- Inspections and Audits
- Ensuring computer systems comply with 21 CFR Part 11.
All units of the Institute must comply with this policy.
Faculty Investigator/Sponsor must complete IND Investigator Responsibility form and provide a copy to the Office of Research Integrity Assurance for review of any research study where an IND application will be filed by a Georgia Tech Investigator.
Impact on Institute
- The CMO and CRO agreements will be GT procurements or sub-agreements. The consultants hired for projects engaged in this kind of technology development are under contract to Georgia Tech and working under the direction of the Principal Investigator on the project. However, the contracts with those organizations may be reviewed at the request of the office of Legal Affairs, Purchasing, or the Office of Sponsored Programs by consulting counsel expert in the specific transaction and FDA regulatory requirements.
- Georgia Tech will require outside consulting counsel to review certain FDA filings and reports.
- The costs for outside consulting counsel to review CRO, CMO and other agreements and for counsel to review FDA filings may or may not be directly chargeable to sponsored research (to be determined). If not a source of funds will need to be identified.
Stakeholders Consulted in Developing This Policy
- Faculty investigator
- Office of Research Integrity Assurance
- Office of Legal Affairs and Risk Management
- Insurance and Risk Management
- Office of Legal Affairs
Compliance Mechanisms Existing or to Be Created
Faculty investigator will complete the IND responsibility form and submit the form to the Office of Research Integrity Assurance for review of any research study where an IND will be held by a Georgia Tech Investigator. All human subject research shall be reviewed and approved by the Georgia Tech IRB or in accordance with a reciprocity agreement with the CRO.
Timing Requirements for this Policy
The Institute must promulgate this policy as soon as possible to comply with FDA regulations.