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Washington State University

HRPP policies & procedures manual

410: Investigational drug or device

1. Purpose

The purpose of this policy is to establish procedures for investigators who hold an Investigational New Drug (IND) or Investigational Device Exemption (IDE) for the test article under study.

2. Policy

If the principal intent of the investigational use of a test article is to develop information about the product’s safety or efficacy, an Investigational New Drug (IND) or Investigational Device (IDE) may be required. If an IND or IDE is required, the investigator proposing to conduct the study must first obtain FDA approval of an IND or IDE application either directly or indirectly via a device or pharmaceutical sponsor. It is also the responsibility of the investigators to meet the requirements of regulations in 21 CFR 312 and 21 CFR 314 (investigational drugs) or 21 CFR 812 and 21 CFR 814 (investigational devices).

3. Specific policies

3.1 Investigator responsibilities

  • For research involving the use of a drug other than the use of a marketed drug, the investigator will determine if an IND is necessary. If the research will involve a medical device that has not been approved by the FDA, the investigator will determine if an IDE is necessary.
  • IRB members who desire guidance about the definitions of INDs and IDEs should see the forms at the end of this section.
  • The investigator will submit the IND or IDE assignment letter to the IRB. If there is debate regarding the need for an IND, the IRB will require that the principal investigator contact the FDA to obtain written documentation that an IND is not necessary and conditions stated in 21 CFR 312.2(B)(1) have been met. Then an IND is not necessary.
  • If the investigator holds an IND or IDE, the investigator will be required to meet with the ORA director and chair to review how the investigator plans to meet the sponsor’s requirements according to 21 CFR 312 and 21 CFR 314 for an IND and 21 CFR 812 and 21 CFR 814 for an IDE. The investigator will put the plan into writing and submit it to the IRB for final approval.  The plan needs to include, but not be limited to: good manufacturing practices, test article storage, labeling, distribution, accountability, site study monitoring, conflict of interest, and periodic reports to the FDA.
  • The investigator is responsible for assuring the IRB that the investigational drugs and devices are stored in a safe and secure manner and are only used in the IRB approved research study and under the direction of the study investigator.
  • The investigator is responsible for assuring the IRB that there are appropriate plans for inventory control, storage, monitoring and dispensing of the test articles (drugs, biologics, or devices).
  • The investigator will obtain informed consent for studies involving an IND or IDE. The consent form will identify the test article as investigational and will inform the subjects that the FDA may inspect the research records.

3.2 IRB review

  • The IRB will review each protocol that uses drugs and biologics to see if an IND or IDE has been received or required.  If one is required, it is the investigator’s responsibility to obtain the FDA assignment letter.
  • Studies involving an IND or IDE will undergo initial and continuing review at a convened meeting of the IRB that includes at least one physician or pharmacist unless the study meets the criteria for expedited review.The pharmacist reviewer will review the application to determine if the plan for storage, control and dispensing of the drug is adequate and to ensure that only the investigators will use the drug on subjects who have provided informed consent.
  • Studies involving an IND or IDE will be reviewed according to policy and procedure and, in addition, the IRB will confirm that the investigator’s plans for inventory controls for storage, monitoring, dispensing of investigational drugs or devices meet appropriate standards.

3.3 Emergency use of a test article

A one-time emergency use of an investigational drug, device, or biologic “test article” by an investigator without prior IRB review and approval is permitted under 21 CFR 56.104(c).

When an investigator conducts an emergency use of a test article in a life-threatening situation without prior IRB review, the activity is research under FDA regulations and the patient is a subject under FDA regulations.  FDA may require data from an emergency use of a test article in a life-threatening situation to be reported in a marketing application.

Emergency use:  The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain URB approval [21 CFR 56.102(d).]

Investigator responsibilities
  • Whenever possible, the investigators are to contact the IRB in advance of the emergency use.
  • The investigator must submit written certification to the IRB within five (5) working days after the use of the test article.
IRB responsibilities (with prior notification)
  • If the IRB chair determines that the circumstances meet regulatory criteria, the IRB chair will inform the investigator and clear them to proceed without IRB review.
  • If the IRB chair determines that the circumstances DO NOT meet regulatory criteria, the IRB chair will inform the investigator and indicate that proceeding with the use without IRB approval will be serious non-compliance.
IRB responsibilities (without prior notification)
  • If the IRB chair determines that the circumstances meet regulatory criteria, the IRB chair will inform the investigator in writing.
  • If the IRB chair determines that the circumstances DO NOT meet regulatory criteria, the IRB chair will inform the investigator in writing that the use without IRB approval is serious non-compliance, and refer the matter to the convened IRB for review under non-compliance with IRB policies and procedures.

4. Applicable regulations and guidelines

21 CFR parts 50 and 56, 50.24

21 CFR 312.2(b), 312.7

21 CFR 312, 314, 812, 814

5. Forms

Addendum 8: Investigational Drugs, Other Drugs & Devices

FDA Guidance: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND

FDA Guidance: Medical Device FAQs

6. Procedures employed to implement this policy & assignment of responsibility

WhoTask
ORA directorMeet with the investigator (who plans on holding the IDE or IND) to ensure that the investigator understands and puts into writing the plan that he/she is to act as the “sponsor” and will adhere to the sponsor responsibilities outlined in 21 CFR 312, 314, or 812, 814.
IRB members Review the IRB submission, including the plan (if investigator holds the IND) for covering the responsibilities outlined in 21 CFR 312, 314, or 812, 814.
ORA director or IRB coordinator Check IDE or IND FDA number and assignment letter to ensure validity.