An investigator administering an investigational drug, agent, or biologic is responsible for the research to be conducted in accordance with the plan of investigation as described in the FDA-approved IND, the signed investigator statement, and the CPHS-approved investigational plan.
Responsibility for Study Subjects
Informed consent from subjects or subjects’ legally authorized representative must be prospectively obtained, unless a wavier of consent has been granted by the CPHS and the rights, safety, and welfare of the subjects in the study must be protected by the investigator.
Responsibility for Control of Drugs
The investigator may not give the investigational drug to any person not authorized under the protocol to receive it. The drug, agent, or biologic may only be used in subjects under the investigator’s personal supervision or under the supervision of physicians who are directly responsible to the investigator. Additionally, the investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.
If the investigational drug is subject to the Controlled Substances Act, the investigator must take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.
Responsibility for Maintaining Records
In order to maintain adequate records, it is expected that the investigator will keep case histories that record all observations and other data needed in the investigation for each individual receiving the investigational drug. Each case history should include the signed and dated consent forms and medical records including progress notes of the physician, the individual’s hospital chart, and the nurses’ notes. It is important to document in the case history that informed consent was obtained prior to participation in the study.
The records should be retained 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. If no application is to be filed or the application is not approved for such indication, records are kept until 2 years after the investigation is discontinued and FDA is notified. The sponsor may have record retention requirements specified in the clinical trial agreement that must be followed instead of the 2 year minimum.
Responsibility to the Sponsor of the Drug
The investigator must furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The sponsor is required to submit annual reports to the FDA on the progress of the clinical investigations.
Serious or unexpected adverse events must be reported to the sponsor immediately. Non-serious adverse events must be reported promptly.
The investigator must provide the sponsor with accurate financial information to allow an applicant to submit complete and accurate certification of disclosure statements as required.
After completion of the study, the investigator must provide the sponsor with a report.
Responsibility to Committee for the Protection of Human Subjects (CPHS)
The investigator must provide copies of all FDA correspondence to CPHS. Additional responsibilities are covered in other sections of the Handbook, such as adverse event reporting (chapter 8), initial protocol review (chapter 3), and the informed consent process (chapter 4).
Responsibility to Federal Agencies
In the event that an employee of the FDA requests access to records or reports made by the investigator (at a reasonable time), the investigator may permit such access for copying or verifying. However, 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 the records do not represent actual case studies.
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