IND Application Procedures: Investigator's Responsibilities
This page provides the key points that investigators should consider in order to understand their responsibilities regarding an IND application. For full description of investigator’s and sponsor’s responsibilities including provisions for disqualification of clinical investigators, refer to 21 CFR 312.50-312.70. For answers to frequently asked questions related to investigator’s statement refer to Guidance for Industry: Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (PDF - 105KB).
An investigator conducting a clinical investigation under an IND application is responsible for ensuring that the investigation is conducted according to the signed investigator’s statement Form 1572 (PDF - 718KB), the investigational plan, and the applicable regulations as referenced above. In addition, an investigator is responsible for protecting the rights, safety, and welfare of subjects under the investigator’s care and for the control of drugs under investigation.
For any investigation, an informed consent must be obtained for each human subject to whom the investigational drug is administered, except the circumstances when clinical emergency research may be conducted without informed consent as described in Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (PDF - 341KB).
Control of the investigational drug:
An investigator is expected to administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subordinate investigator responsible to the investigator. The investigator must not supply the investigational drug to any person not authorized to receive it.
If the investigational drug is subject to the Controlled Substances Act, the investigator must take adequate precautions to prevent theft or diversion of the substance into illegal channels of distribution.
An investigator is required to maintain adequate records of the disposition of the investigational drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator is expected to return the unused supplies of the drug to the manufacturer, or otherwise provide for disposition of the unused supplies of the drug.
An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
An investigator is expected to retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.
For investigator’s responsibilities related to IND safety reporting, annual reporting and other reporting, refer to the IND Application Reporting.
For reporting requirements related to financial disclosure of clinical investigators, refer to Guidance for Clinical Investigators, Industry and FDA Staff: Financial Disclosure by Clinical Investigators (PDF - 165KB).
Assurance of IRB review:
An investigator is expected to assure that an Institutional Review Board (IRB) is involved in the oversight of the study and is responsible for the initial and continuing review and approval of the proposed clinical study. The investigator is also expected to assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others. An investigator is expected not to make any changes in their investigation without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects. For additional information on investigator and IRB responsibilities refer to Guidance for IRBs, Clinical Investigators, and Sponsors (PDF - 62KB)
For detailed information about adverse event reporting to IRBs refer to Guidance for Clinical Investigators, Sponsors, and IRBs (PDF - 61KB).
An investigator is expected to permit FDA to have access to, and copy, and verify any records or reports made by the investigator. The investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.
IND Application Status
IND Status Description Active (ongoing) An IND application is in effect and the investigations are ongoing. On Hold An active IND application where some or all of the investigations are on Clinical Hold. Inactive An IND application may be inactivated upon the IND applicant’s request or FDA’s request. Inactivation of the IND application may occur if, for example, no subjects entered clinical trial(s) for 2 years or longer, or the IND application is on hold for 1 year or longer. An inactive application may be re-activated if activities under the IND application have restarted. Withdrawn An IND application may be withdrawn by the applicant if development of the investigational product has been abandoned for any reason. Terminated An IND application may be terminated by FDA if, for example, (1) human subjects are exposed to unreasonable or significant risk, or (2) methods, facilities and controls used for the manufacturing are inadequate to establish and maintain appropriate standards for quality and purity as needed for subject safety. Additional information on the grounds for termination of an IND application may be found in 21 CFR 312.44.