FDA Requirements for Investigators Who are Also Sponsors

1. Submit IND application, form 1571 and other required documents to FDA. (21 CFR 312.23)
2. Label the investigational drug in accordance with FDA regulations. (21 CFR 312.6)
3. Limit promotion. If any promotion is done, it must be done in accordance with IRB and FDA requirements. (21 CFR 312.7)
4. Select qualified investigators based on training and experience. (21 CFR 312.53)
5. Ship investigational drugs only to investigator(s) participating in the investigation. (21 CFR 312.53)
6. Obtain FDA Form 1572 from the investigator(s). (21 CFR 312.53)
7. Obtain a written statement that the investigator(s) will conduct the study as outlined in the protocol. (21CFR 312.53)
8. Obtain relevant financial information from the investigator(s). (21 CFR 312.53)
9. Select a monitor to oversee the progress of the investigation. (21 CFR 312.53)
10. Comply with FDA regulations regarding emergency use. (21 CFR 312.54)
11. Keep investigator(s) informed on the safety and effectiveness of the drug. (21 CFR 312.55)
12. Monitor the progress of all IND investigations. (21 CFR 312.56)
13. Terminate investigator(s) participation when investigator(s) fails to follow protocol. (21 CFR 312.56)
14. Review and evaluate the evidence relating to the safety and effectiveness of the drug as it is obtained from each investigator(s). (21 CFR 312.56)
15. Send safety reports to FDA according to the 2010 final rule, Investigational New Drug Safety Reporting Requirements for human drug and biologics (21 CFR 312.32) and for Bioavailability and Bioequivalence Studies (21 CFR 320).
16. Discontinue the study if the investigational drug presents an unreasonable and significant risk to subjects. (21 CFR 312.56)
17. Notify the FDA, IRB and the investigator(s) if the study is discontinued. (21 CFR 312.56)
18. Maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. (21CFR 312.57)
19. Maintain complete and accurate records of payments made to clinical investigator(s). (21 CFR 312.57)
20. Permit and facilitate monitoring and auditing by the IRB or inspection by federal or state regulatory agencies (e.g. FDA or Drug Enforcement Administration for investigations of controlled substances) as appropriate. (21CFR 312.58)
21. Assure that investigator(s) return all unused investigational drugs. (21 CFR 312.59)
22. Require investigator(s) to maintain adequate drug records (21 CFR 312.62)
23. Require investigator(s) to keep case histories on each individual administered the investigational drug or employed as a control in the investigation. (21 CFR 312.62)
24. Collect reports (financial, progress, safety, and final report) from investigator(s). (21 CFR 312.64)
25. Require investigator(s) to meet local IRB requirements. (21 CFR 312.66)
26. Require investigator(s) to store the investigational drug in a secure area. (21 CFR 312.69)
27. Register the study at ClinicalTrials.gov per the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Public Law 110-85).
    • Requirements and instructions for registering trials
    • UK ClinicalTrials.gov Guidance and General Information (includes information on obtaining access to the University of Kentucky organizational account on ClinicalTrials.gov)  
28. Comply with FDA regulations on electronic records and electronic signatures (21 CFR 11).
29. Comply with FDA financial disclosure requirements (21 CFR 54).

1. Submit a complete IDE application to the FDA. (21 CFR 812.20)
2. Submit the investigational plan and report of prior investigations (21 CFR 812.25 and 21 CFR 812.27) to the IRB at each institution where the investigation is to be conducted.
3. Obtain FDA & IRB approval for IDE. (21 CFR 812.42)
4. Select investigator(s) with appropriate training and experience. (21 CFR 812.43)
5. Obtain a signed agreement from the investigator with the required FDA documents. (21 CFR 812.43)
6. Select a monitor in accordance with FDA regulations. (21 CFR 812.43)
7. Ship investigational devices only to qualified investigators. (21 CFR 812.43)
8. Supply the investigator(s) with copies of the investigational plan and copies of prior device investigations. (21 CFR 812.45)
9. Label the device in accordance with FDA labeling provisions of the IDE regulation and with the statement "CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use." (21 CFR 812.5)
10. Ensure that investigator(s) are complying with FDA, IRB, and sponsor requirements. (21 CFR 812.46)
11. Conduct an evaluation of unanticipated adverse events and terminate the study if necessary. (21 CFR 812.46)
12. Resume terminated studies only after receiving approval from the FDA and IRB. (21 CFR 812.46)
13. Ensure that each investigator obtains consent for each subject before being enrolled in the study. (21 CFR 50)
14. Maintain accurate and complete records in accordance with FDA regulations. (21 CFR 812.140)
15. Permit and facilitate monitoring and auditing by the IRB or inspection by federal or state regulatory agencies as appropriate. (21 CFR 812.145)
16. Provide required reports to IRB, investigator(s) and FDA in a timely manner. (21 CFR 812.150)
17. Limit promotion of the device. Commercialization, promotion, and misrepresentation of an investigational device and prolongation of the study are prohibited.  (21 CFR 812.7)
18. Comply with federal regulations regarding emergency use. (21 CFR 812.47)
19. Register the study at ClinicalTrials.gov per the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Public Law 110-85).
    1. Requirements and instructions for registering trials
    2. UK ClinicalTrials.gov Guidance and General Information (includes information on obtaining access to the University of Kentucky organizational account on ClinicalTrials.gov)  
20. Comply with FDA regulations on electronic records and electronic signatures (21 CFR 11).
21. Comply with FDA financial disclosure requirements (21 CFR 54).

Nonsignificant risk device sponsors must comply with the abbreviated IDE requirements under 21 CFR 812.2(b): 

1. Select investigator(s) with appropriate training and experience. (21 CFR 812.43)
2. Select a monitor in accordance with FDA regulations. (21 CFR 812.43)
3. Ship investigational devices only to qualified investigators. (21 CFR 812.43)
4. Supply the investigator(s) with copies of the investigational plan and copies of prior device investigations. (21 CFR 812.45)
5. Label the device in accordance with FDA labeling provisions of the IDE regulation and with the statement "CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use." (21 CFR 812.5)
6. Obtain IRB approval of the investigation as a nonsignificant risk device study and maintain IRB approval during the investigation. (21 CFR 812.2)
7. Ensure that investigator(s) are complying with FDA, IRB, and sponsor requirements. (21 CFR 812.46)
8. Conduct an evaluation of unanticipated adverse events and terminate the study if necessary. (21 CFR 812.46)
9. Resume terminated studies only after receiving approval from the IRB, and if terminated due to an unanticipated adverse device effect, also obtain FDA approval to resume the study. (21 CFR 812.46)
10. Ensure that each investigator obtains consent for each subject unless the IRB grants a waiver under 21CFR56.109(c).
11. Ensure that each investigator maintains accurate and complete records in accordance with FDA regulations and reports the results to the appropriate parties. (21 CFR 812.140 & 21 CFR 812.150)
12. Permit and facilitate monitoring and auditing by the IRB or inspection by federal or state regulatory agencies as appropriate. (21 CFR 812.145)
13. Limit promotion of the device. Commercialization, promotion, and misrepresentation of an investigational device and prolongation of the study are prohibited. (21 CFR 812.7)
14. Register the study at ClinicalTrials.gov per the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Public Law 110-85).
    1. Requirements and instructions for registering trials
    2. UK ClinicalTrials.gov Guidance and General Information (includes information on obtaining access to the University of Kentucky organizational account on ClinicalTrials.gov)  
15. Comply with FDA regulations on electronic records and electronic signatures (21 CFR 11).
16. Comply with FDA financial disclosure requirements (21 CFR 54).