• Roles and responsibilities
• Good clinical practices
• Drug development legislation
• Ethical considerations in clinical research
• Study documents
• Clinical trial phases
• Study design
• Use of placebo
• Site evaluation Visit
• Study budget
• The contract
• FDA form 1572
• Financial disclosure
• Institutional Review Board
• Informed consent and HIPAA
• Continued IRB involvement
• Study nitiaion documents
• Investigator meeting and study initiation visit
• Investigator study files
• Finding study subjects
• The informed consent process
• Enrolling the first subjects
• Classifying and reporting adverse events
• Preparing for a monitor visit
• Subject recruitment issues
• Retention of subjects
• Ongoing subject recruitment
• Final subject selection
• Managing compliance
• FDA inspections
• Study closure
• After the study

This module is designed for those working for investigative site teams, sponsors, or CROs, including clinical investigators, research coordinators, office coordinators, nurses, physician assistants, clinical research coordinators, and other professionals involved in clinical trials.

• Physicians
• Pharmacists
• Physician assistants
• Nurse practitioners
• Research scientists
• Clinical research professionals
   

Clinical Trial Fundamentals: Study Preparation: After completing this activity, you should be better able to:

• Differentiate the roles and responsibilities of the clinical investigator, the study staff, and the sponsor
• Identify the clinical phases of drug development and what is done at each phase
• Outline the clinical trial regulations and Good Clinical Practice guidelines on conducting a clinical trial and essential documents
• List the foundations of ethical conduct in clinical research including its impact on clinical research
• Recognize the history behind human subject protection
• Compare different study designs and discuss the merits of each
• Determine how to determine a study budget

Clinical Trial Fundamentals: Study Initiation: After completing this activity, you should be better able to:

• Define the roles and responsibilities of the Institutional Review Board or Independent Ethics Committee
• Evaluate the correct way to complete the FDA Form 1572
• List financial disclosure requirements of the clinical investigator and study staff
• Distinguish the elements of the informed consent document, including HIPAA authorization
• Identify the documents necessary to submit to the IRB before a study begins
• Determine the purpose, attendees, and activities of the study initiation meeting and the investigator meeting
• Analyze how clinical trial study files should be organized before the study starts

Clinical Trial Fundamentals: Conducting the Study: After completing this activity, you should be better able to:

• Compare methods for successful subject recruitment, retention, and compliance
• Utilize the informed consent process during a clinical trial
• Classify adverse events
• Evaluate the reporting of adverse events
• Determine how to manage monitoring visits
• Identify FDA inspection details including preparation, the inspection process, and consequences for regulatory violation
• Outline the steps in preparing a post-study critique and study closure