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