For FDA-regulated research involving investigational drugs and biologics investigators are required to abide by the following:
- Restrictions on promotion of investigational drugs
- Requirements for general responsibilities of investigators
- Requirements for control of the investigational drug
- Requirements for investigator recordkeeping and record retention
- Requirements for investigator reports
- Requirements for assurance of IRB review
- Requirements for inspection of investigator’s records and reports
- Requirements for handling of controlled substances. In addition, follow:
- California requirements for controlled substances for research taking place in California, and
- University of California requirements for controlled substances
- For investigator-initiated research involving investigational drugs, follow:
For FDA-regulated research involving investigational devices:
- Mobile Health Apps: If you’re developing a health app for mobile devices and want to know which federal laws apply, check out the Federal Trade Commission’s interactive tool here.
- General responsibilities of investigators:
- An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator’s care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with 21 CFR §50.
- Specific responsibilities of investigators
- Maintain the following accurate, complete, and current records relating to the investigator’s participation in an investigation
- FDA Inspections
- Prepare and submit complete, accurate, and timely reports:
- For investigator-initiated research involving investigational devices, follow FDA requirements in 21 CFR Part 812, Sub-part B for obtaining Investigational Device Exemption (IDE) approval; and
- Follow Worksheet: Devices (HRP-307) for information concerning legal and regulatory requirements that apply to the use of investigational test articles
For more information about conducting FDA regulated research, and additional requirements for Clinical Trials (ICH-GCP) please refer to the Investigator’s Manual (HRP-103).