V. What are the sponsor-investigator’s responsibilities as an investigator?

The SI has all the responsibilities of investigators in any clinical trial.

A. General responsibilities [21 CFR 312.60]

  • Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations
  • Protecting the rights, safety, and welfare of subjects under the investigator’s care

B. Assurance of IRB review [21 CFR 312.66]

The SI is responsible for assuring that:

  • A qualified IRB will be responsible for initial and continuing review and approval of the investigation
  • All changes and unanticipated problems involving risk to human subjects or others are reported to the IRB
  • No changes in the investigation will be made without prior IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects

C. Control of the investigational drug [21 CFR 312.61]

As investigator, the SI must administer the investigational drug only to subjects under his/her direct supervision, or under the supervision of a sub-investigator responsible to the investigator. The SI must also ensure that the investigational drug is not given to any person not authorized to receive it. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under 21 CFR 312.59.

D. Investigator record Keeping

Accurate documentation of the following must be maintained.

As investigator, the SI will maintain accurate case histories that record all observations and other data pertinent to the investigation on each subject who received the investigational drug and each subject who was a control in the investigation.

Case histories include the case report forms, supporting data such as signed, dated consent forms, and medical record information including, for example, progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.

The SI is responsible for maintaining adequate records of the disposition of the drug, including dates, quantity, and use by subjects.

E. Investigator record retention [21 CFR 312.62]

SIs are required to maintain:

  • All correspondence relating to the use of human subjects in research, as well as copies of the IRB application forms, approval notices, and signed Informed Consent Documents (ICD)
  • UI policy requires that:
    • Research records that include Protected Health Information (PHI) must be kept for six years after the close of the project in HawkIRB
    • Research records that do not involve PHI must be kept for at least 3 years after the close of the study
    • Research records for VAMC studies must be kept indefinitely

F. Inspection of sponsor-investigator’s records and reports [21 CFR312.68]

The sponsor-investigator (SI):

  • Must allow FDA employees access to all records and reports at their request
  • Shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to 21 CFR 312.62
  • Is not required to divulge participant 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.

G. Handling of controlled substances [21 CFR 312.69]

As investigator, the SI must take adequate precautions to ensure the safe and secure handling of the investigational drug if it is a controlled substance. This includes proper storage in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.