Overview

This bundle 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 four 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, 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.
Informed Consent: Comprehensive Concepts and Components equips learners with a deep understanding of the informed consent process, covering every essential component of a complete and compliant consent form as outlined by the ICH and FDA. Participants will gain practical guidance on crafting clear, effective consent language, explore the advantages and challenges of electronic informed consent, and examine real-world research and case studies highlighting the use of eConsent in modern clinical trials.

A fictitious yet realistic clinical trial scenario is woven throughout the first 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
- 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
- Introduction to informed consent
- Exceptions to requirements for informed consent
- Comprehension guidelines
- Elements of consent
- Writing the introduction and purpose statement
- Explaining procedures
- Explaining risks and benefits
- Explaining alternatives, cost, and compensation
- Explaining confidentiality and subject rights
- Storage of specimens
- Contact information, consent statements, and signatures
- Long form versus short form
- Long form versus short form
- Changes to informed consent under HIPPA

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

The content is also relevant for regulatory affairs team members at both sponsor and study sites.

Learning objectives

Module 1: Clinical Trial Fundamentals: Study Preparation
- 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: Clinical Trial Fundamentals: Study Initiation
- 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: Clinical Trial Fundamentals: Conducting the Study
- 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.
Module 4: Informed Consent: Comprehensive Concepts and Component
- Recognize key aspects of the informed consent process, including procedures for securing consent and adherence to the Health Insurance Portability and Accountability (or, HIPAA) Privacy Rule.
- Apply best practices for readability and comprehension when creating an informed consent document.
- Differentiate between required and additional elements of informed consent.
- Identify how and where the elements of informed consent are incorporated into a consent document.
- Distinguish between the long form and short form consent document.

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Clinical Trial Management Comprehensive eLearning Bundle

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.