Introduction

All courses in this set must be completed (unless this is an optional set).

Course name Actions
Study Director Core Training 1-1: What Makes a Study GLP
Study Director Core Training 1-3: Ensuring That the Overall Conduct Is As Per the GLP Regulations
Study Director Core Training 1-4: Overall Regulatory Submission Process
and

Drug Development

All courses in this set must be completed (unless this is an optional set).

Course name Actions
Study Director Core Training 2-1: Overall Drug Development With the Different Paths (Orphan Drugs, Biologics, Generics)
Study Director Core Training 2-2: Overall Drug Development for Veterinary Medicines
Study Director Core Training 2-3: Overall Development for Chemicals/Agrochemicals
and

Animal Care and Welfare

All courses in this set must be completed (unless this is an optional set).

Course name Actions
Study Director Core Training 3-1: Animal Welfare Regulations (North America vs Europe and Canada)
Study Director Core Training 3-2: Study Director Oversight: Interactions with the Veterinary Group
Study Director Core Training 3-3: Humane Experimental Endpoints
Study Director Core Training 3-4: General Concepts of Veterinary Care in Nonclinical Studies
Study Director Core Training 3-5: Standard Supportive Treatments and General Principles of Analgesia and Anesthesia in the Context of Nonclinical Studies
Study Director Core Training 3-6: IACUC/AWEC Submission Process
and

Study Design and Data Management

All courses in this set must be completed (unless this is an optional set).

Course name Actions
Study Director Core Training 10-1: Guidelines for Study Design and Required Parameters
Study Director Core Training 10-2: Clinical Observations and Veterinary Physical Examinations
Study Director Core Training 10-3: Body Weight and Food/Water Consumption/Evaluation
Study Director Core Training 10-5: Respiratory Evaluations and Standard Neurotoxicity Endpoints
Study Director Core Training 10-6: Standard Immunology and Immunogenicity Endpoints
Study Director Core Training 10-7: Pharmacokinetics/Toxicokinetics
and

Study Director Interactions: Veterinary Staff

All courses in this set must be completed (unless this is an optional set).

Course name Actions
Study Director Oversight: Interactions with the Veterinary Group