RESPONSIBILITY OF THE
PRINCIPAL INVESTIGATOR (PI)
in Human Subjects Research

The PI is responsible for:

• insuring that all key personnel involved in the study, including the PI, have completed the CITI Course in protection of human research subjects prior to the start of an IRB-approved study.
• protecting human subjects participating in the study. 
• submitting any additions, corrections or modifications to the IRB that change the full protocol, consent form(s), HIPAA, advertisements, etc. before implementing them.
• submitting documentation for continuing review in a timely manner.  Continuing review letters are sent to PIs seven to eight weeks in advance of the expiration of the study to provide the PI ample time to prepare and submit the required documentation.
• immediately reporting any serious adverse event(s) (SAEs) within 48 hours of learning of the event, five days for any external SAE, and any complications (locally or at other sites) that may occur as a result of the study.

For additional information regarding the responsibilities of the PI in Human Subjects research, see http://www.fda.gov/cder/guidance/959fnl.pdf.