All University faculty members who file an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) with the Food and Drug Administration (FDA) as a sponsor-investigator must submit all documents relevant to the IND/IDE to a University documentation unit (a central file).
Documents to be kept by the IND/IDE Documentation Unit include the application, communications, safety reports, amendments, and annual reports. These documents will be used to remind and assist sponsor-investigators of their reporting obligations to the FDA and to track reports and communications with the FDA. The IND/IDE Documentation Unit will not ascertain compliance, but will assist sponsor-investigators to be compliant.
This policy applies only when faculty members serve as the sponsor of an IND or IDE. It does not apply to the more common situation when a faculty member serves only as the principal investigator on an IND or IDE and the sponsor is a pharmaceutical, biotechnology, or medical device company.
FDA regulations are complex and difficult to interpret. The FDA is continually issuing updates and new guidance documents. It is difficult and time consuming to keep abreast of the changes to the regulations. The regulations require that certain obligations be met at specific times. Proper adherence to FDA regulations is critical to managing risk. The FDA will not directly communicate with the University regarding a sponsor-investigator's IND or IDE. The University, however, is potentially liable for the actions of its faculty members.
In order to ascertain compliance with FDA regulations, the IND/IDE Documentation Unit will receive information from faculty members and from other units such as the IRB and Office of Regulatory Affairs. The IND/IDE Documentation Unit will notify sponsor-investigators when reporting obligations need to be met. If sponsor-investigators fail to comply with FDA regulations, the Office of Regulatory Affairs and other appropriate institutional offices will be notified.
- Food and Drug Administration
- The regulatory authority in the United States which oversees the pharmaceutical and medical device industries. The FDA is responsible for ensuring that the drugs and medical devices marketed in the US have a greater benefit than risk when used according to manufacturer's directions.
- IND/IDE Assistance Program
- A unit of the Academic Health Center under the supervision of the Assistant Vice President for Research, AHC. The IND/IDE Assistance Program provides free, optional assistance to faculty members who are submitting an IND or IDE to the FDA (or require advice as to whether an IND or IDE is required). The IND/IDE Assistance Program will operate the IND/IDE Documentation Unit as an obligatory requirement for all sponsor-investigators of an IND or IDE.
- Investigational device exemption (IDE)
- Document submitted to the FDA to allow for the conduct of a clinical study using a significant risk device that is new or not approved for that use.
- Investigational new drug application (IND)
- Document submitted to the Food and Drug Administration (FDA) to allow for the conduct of a clinical study using a drug that is new or not approved for that dosage form or indication.
- An individual who actually conducts a clinical investigation.
- A person who takes responsibility for and initiates a clinical investigation. (This is often a pharmaceutical, biotechnology, or medical device company).
- An individual (not a company) who both initiates and conducts an investigation and complies with all the obligations of both a sponsor and an investigator.
- Submit copies of all relevant documents (IND or IDE application, all communications to and from the FDA, safety reports, protocol amendments, and annual reports) to the Documentation Unit
- IND/IDE Assistance Program
- Assist faculty members in determining whether an IND or IDE application to the FDA is required. Provide optional assistance in preparing an IND or IDE. Operate the IND/IDE Documentation Unit.
- IND/IDE Documentation Unit
- Maintain a central file (copies) of all documents relevant to a sponsor-investigator IND or IDE held by a faculty member. Remind sponsor-investigators when (annual) reports or other communications with the FDA are required. Report suspected or known instances of noncompliance with University, FDA, or other applicable policies to the Office of Regulatory Affairs for investigation and resolution.
- November 2003