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Preface 1 Regulatory Application Requirements Shanthi Ganeshan and Connie Freund 2 John Klein and Sonya Edgerton 3 Sam Sather and Jennifer Lawyer 4 and Sonya Edgerton 5 Karen Truhe 6 21 CFR 50 – Informed Consent Joe Near 7 Glenda Guest 8 Aurea Flores 9 Protected Health Information and Privacy in Clinical Trials (HIPAA) Sam Sather 10 Good Pharmacovigilance Practices (GVP) Jessica Chu 11 Data Integrity and 21CFR11 for GCPs Randall Basinger 12 Preparing for FDA inspections at sponsor/investigator sites Tommy Lee and Sam Sather 13 Regulations relating to the Placebo response in Clinical research Graham Bunn and Arthur Ooghe |