The Sponsor-Investigator assumes all sponsor responsibilities required by the FDA in 21CFR 312, particularly Subpart D on  record keeping and prompt reporting of safety reports to the FDA.

 

Some key FDA requirements in conducting Sponsor-Investigator research include:

 

• Selection of research staff qualified by training and experience
• Commitment to personally conduct or supervise the investigation according to the research plan
• Selection of study monitor(s) qualified to monitor the progress of the project
• Maintenance of adequate records showing the receipt, shipment, or other disposition of the investigational drugs and records of participants’ case histories
• Completion of regulatory filings, including submission of amendments, annual and final reports
• Timely submission of reports (adverse events and other):
• Written (Notify the FDA and PIs no later than 15 days from observation)
• Serious unexpected adverse experience associated with the use of the drug
• Any findings from tests in laboratory animals that suggest significant risk for human subjects
• Telephone or facsimile reports (Notify the FDA no later than 7 days from observation if fatal or life-threatening event)
• Other reports
• Safety information should be summarized in annual reports

 

Sponsor-Investigator requirements are in Title 21, Code of Federal Regulations, Part 312 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

 

21 CFR 312.57  Recordkeeping

21CFR 312.60 General responsibilities of investigators

21CFR 312.62 Investigator recordkeeping and record retention

21CRF 312.64 Investigator Reporting requirements

21CFR 312.68 Inspection of Investigator’s records and reports