The Principal Investigator's Responsibilities in Research

More documents

Recommendations

Info

DUHS PI Responsibilities 15. Will conduct research involving FDA-regulated FDA regulated products under an IND application or IDE, Will comply with all applicable FDA regulations and fulfill all investigator responsibilities [or investigator-sponsor investigator sponsor responsibilities, where appropriate], including those described at 21 CFR 312 and 812, the text of which is found at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr /cfrsearch.cfm
DUHS PI Responsibilities 16. I Will NOT enroll participants in research prior to the review and approval of the research by the IRB. I Will report promptly to the IRB proposed changes in the research conducted under this Agreement. I Will NOT initiate changes in research activities without prior review and approval by the IRB, except when necessary to eliminate immediate hazards to the research participants.
Page 1 and 2: The Principal Investigator’s Resp
Page 3 and 4: Duke University Health System PI Re
Page 5 and 6: DUHS PI Agreement Commitment of a
Page 7 and 8: DUHS PI Agreement Preamble continue
Page 9 and 10: DUHS PI Responsibilities 2. I recog
Page 11 and 12: 4. DUHS PI Responsibilities I will
Page 13 and 14: DUHS PI Responsibilities 6. Will em
Page 15 and 16: DUHS PI Responsibilities 8. I will
Page 17 and 18: DUHS PI Responsibilities 10. I have
Page 19 and 20: DUHS PI Responsibilities 12. Will s
Page 21: DUHS PI Responsibilities 14. I agre
Page 25 and 26: DUHS PI Responsibilities 18. I (and
Page 27 and 28: DUHS PI Responsibilities 20. Unders
Page 29 and 30: DUHS PI Responsibilities 22. In the

The Principal Investigator's Responsibilities in Research

Create successful ePaper yourself

Delete template?

Save as template?