• Responsibilities of the investigator and sponsor
• Study design and documents
• Responsibilities of the study staff
• Institutional Review Boards
• Elements of informed consent and HIPAA
• eConsent
• Subject recruitment, selection, retention, and compliance
• Classifying, recording, and reporting adverse events
• Managing monitoring visits
• FDA inspections

This module is designed for professionals involved in:

• Clinical research, including research scientists, clinical research associates, study coordinators, clinical trial recruiters, principal investigators, nurses, physician assistants, office coordinators, and clinical study team
• Regulatory affairs

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

Informed Consent: Comprehensive Concepts and Components: After completing this activity, you should be better able to:

• Define informed consent and identify the key characteristics of the process
• Identify situations that would require informed consent, and exceptions to consent
• Select the proper methods of communicating with and gaining consent from various populations of potential study subjects
• Determine the proper use of electronic consent, its benefits, and concerns with its use
• Recognize common problems with completed consent forms
• Evaluate a complete and appropriate consent form
• List which consent form components are necessary based on the characteristics of the study and potential study subjects
• Analyze completed consent forms for comprehensiveness, appropriateness, and accuracy
• Differentiate between short and long consent forms, and explain when each is appropriate
• Define informed consent requirements under HIPAA