Overview

This program provides clinical research professionals with the knowledge and practical skills needed to conduct safe, effective, and compliant clinical trials from initiation through study completion. Across three integrated modules, learners will gain a comprehensive understanding of the clinical trial process and the responsibilities of investigators, study teams, and sponsors.

Study Preparation builds on this foundation by clarifying roles and responsibilities, exploring the phases of clinical trials, reviewing essential documents, addressing study design and placebo use, and managing critical site logistics such as budgets, contracts, and evaluation visits.
Study Initiation introduces the foundational steps in starting a trial, including FDA forms, elements of informed consent, HIPAA requirements, Institutional Review Board (IRB) processes, essential study files, and key meetings.
Conducting the Study guides learners through day-to-day trial operations, including subject identification, enrollment, and retention; adverse event classification and reporting; monitor visits; FDA inspections; compliance considerations; and study closure activities.

To bring the material to life, a fictitious yet realistic clinical trial scenario is woven throughout all three modules, giving learners the opportunity to see how concepts connect and apply in practice.

Featured topics

Featured Topics:
- Roles and responsibilities in a clinical trial
- Good clinical practices
- Legislation, regulations, and ethical considerations
- Clinical trial phases
- Study documents
- Study design and control
- Study preparation logistics
- FDA forms
- Financial disclosures
- Informed consent
- HIPAA
- Institutional review board
- Important meetings
- Study files
- Subject recruitment
- Subject enrollment
- Classifying and reporting adverse events
- Retaining subjects and managing compliance
- Monitor visits, sponsor audits, and FDA inspections
- Study closure

Who should attend?

This module is designed for professionals working for investigative site teams, sponsors, or CROs, including:
- Physicians
- Pharmacists
- Physician assistants
- Nurse practitioners
- Research scientists
- Clinical research professionals
- Clinical investigators
- Office coordinators
- Other professionals involved in clinical trials

Learning objectives

Module 1: Study Preparation: At the conclusion of this course, participants should be able to:
- Differentiate the roles and responsibilities of the clinical investigator, the study staff, and the sponsor.
- Recognize key drug development legislation and regulations.
- Outline the foundations of ethical conduct in clinical research, including its impact on clinical research.
- Distinguish the four clinical phases of drug development by their associated characteristics.
- Recognize different study design elements and the merits of each.
- Identify key considerations in preparing for a site evaluation visit, determining the study budget, and negotiating the contract.
Module 2: Study Initiation: At the conclusion of this course, participants should be able to:
- List the financial disclosure requirements of the study team.
- Differentiate between the basic and additional elements of informed consent.
- Recognize the primary responsibility of the Institutional Review Board and its role in a clinical trial.
- Distinguish between the investigator meeting and the study initiation meeting in terms of characteristics, meeting topics, and attendees.
Module 3: Conducting the Study: At the conclusion of this course, participants should be able to:
- Evaluate methods and guidelines for recruiting subjects for a clinical trial.
- Identify non-compliance and subject retention issues.
- Apply the appropriate informed consent procedures when enrolling subjects.
- Determine adverse event classification and reporting responsibilities.
- Recognize the three Establishment Inspection Report classifications and potential consequences of unfavorable observations from an FDA Inspection.
- Outline study closure procedures.

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Clinical Trial Fundamentals eLearning Program

Overview

Featured topics

Who should attend?

Learning objectives

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