Once a protocol is approved by the IRB, the Principal Investigator (PI) and his/her research team are responsible for management of the study.  Only those procedures approved in the protocol may be performed.  Consent must be documented and obtained in accordance with the protocol.  Changes to approved protocols are to be requested in advance via the modification process.  Unexpected negative outcomes are to be reported using the Adverse Event Form.  Continuing review must occur at least annually for the life of the study.  Thorough records must be maintained throughout.  Upon conclusion of a study, submission of a closing report is required. 

 

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 Adverse Events and Unanticipated Problems

 Closing a Protocol

 Continuing Review

 Data Safety Monitoring

 External Audits 

 Modifications to approved research

Payments to Research Subjects Policy

 Record Keeping (Under Revision)

 Recruitment of Subjects

 Reporting Protocol Deviations and Violations