Policies for Good Clinical Practice

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Standard Operating Procedures: For Good Clinical Practice
Table of Contents
Section 1 Definitions and Acronyms
Section 2 Administration Policies-Overview, Regulatory Support and References
Section 3 Institutional Review Board- Overview, Regulatory Support and References
Section 4 Privacy of Protected Health Information in Research- Overview, Regulatory Support and References
Section 5 Confidentiality of Research Information- Overview, Regulatory Support and References
Section 6 General Administrative Policies- Overview, Regulatory Support and References
Section 7 Prinipal Investigator-Overview, Regulatory Support and References
Section 8 Protocol-Overview, Regulatory Support and References
Section 9 Informed Consent Policies-Overview, Regulatory Support and References
Section 10 Investigator Initiated Verses Off Label Use-Overview, Regulatory Support
Section 11 Research Documentation Maintenance-Overview, Regulatory Support and References
Section 12 HIPAA Research Policy- Overview, Regulatory Support
Section 13 Investigator Binder/ Essential Documents for a Clinical Trial- Overview, Regulatory Support, and References
Section 14 Recruitment and Retention of Subjects- Overview, Regulatory Support and References
Section 15 Adverse Events/ SAE and Unanticipated Problems- Overview, Definition and References
Section 16 Deviations/Violations- Overview and Regulatory
Section 17 Accountability of Investigational Products- Overview, Regulatory Support and References
Section 18 Laboratory Process- Overview, Regulatory Support and References
Section 19 Monitoring- Overview, Regulatory Support and References
Section 20 Audits- Sponsor and/or Regulatory (FDA)
Section 21 Conflict of Interest- Overview, Regulatory Support and References
Section 22 Emergency Procedures- Overview, Regulatory
Section 23 Appendix Forms/Logs
Section 24 Archiving Changed SOP's- Overview, Regulatory Support and References
Section 25 Index