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Study Coordinator and Research Staff
- All key study personnel must complete initial and continuing education in human research protections annually, to remain up-to-date on federal regulations, Vanderbilt policies and procedures, and compliance expectations. This entails completing the three to four required CITI modules initially, then one additional module or human research protection educational session annually providing documentation of completion to the IRB.
- Adheres to federal regulations, state and local laws, institutional policies, IRB policies and procedures regarding the safety and protection of human participants, and Good Clinical Practice (GCP).
- Reports adverse events and unanticipated problems involving risks to the participants and others to the IRB according to Institutional policy, IRB policies and procedures, DSMB/C, VU or VUMC Risk Management, sponsors, and appropriate Federal agencies as required.
- Acts as a liaison between the IRB, the Investigator, and the sponsor.
- Promotes compliance and maintains documents in accordance with federal and state regulations, sponsor, and institutional policies and procedures regarding the safety and welfare of human participants.
- Assures participant privacy and confidentiality according to HIPAA guidelines, institutional regulations, and IRB policies and procedures.