Investigator Manual

Investigator Manual

This document will guide investigators through the policies and procedures, as well as, regulations and guidance specific to LSUHSC - Shreveport that are related to the conduct of Human Research. 

   
Human Research Basics
Regulatory And Institutional Requirements
Adverse Events Including Serious Adverse Events, Unexpected Adverse Drug Experiences, and
Unanticipated Adverse Device Effects
Monitoring, Auditing, and Inspection Preparation
Additional Tips for an FDA Inspection
Appendix A:
                    2. De-Identified Protected Health Information
                    3. Limited Data Set Provisions
                    4. Waiver of Authorization
                    5. Activities Preparatory to Research
Appendix B
Appendix C