Clinical Research Training Program

Before delving into the specific sessions, it is essential to establish a foundational understanding of clinical research. This preliminary segment will provide participants with critical background knowledge and set the stage for subsequent discussions.

• The History of Clinical Research: Tracing the evolution of clinical research practices through significant milestones.
• Terminology: Familiarizing participants with key terms and definitions commonly used in the field.
• Key Players in Clinical Research: Identifying the roles of investigators, sponsors, study coordinators, and other stakeholders.
• Regulatory Bodies: Overview of global and regional entities such as the FDA and EMA that govern clinical research practices.
• An Introduction to ICH GCP & FDA Regulations: Understanding the International Council for Harmonisation guidelines and FDA standards for clinical trial conduct.
• The Clinical Trial Phases: A detailed overview of the distinct stages involved in clinical trials, from Phase I through Phase IV.
• Challenges in Clinical Research: Addressing common obstacles and ethical considerations encountered in the field.

This section outlines international guidelines for conducting ethical clinical trials and protecting participant rights. It covers:

• ICH GCP E6 (R3) Good Clinical Practice
• 11 Principles of ICH GCP E6 (R3)
• Investigator Responsibilities
• Sponsor Responsibilities
• Institutional Review Board
• Vulnerable Populations
• Informed Consent
• HIPAA Authorization

This session outlines the necessary regulatory records, documents, and reporting requirements for clinical research trials. It emphasizes the importance of complete and maintained regulatory documents throughout a trial.

• Regulatory Binder and eRegulatory
• Pre-Trial Essential Records
• FDA Form 1572
• Investigator Brochure
• Training Logs
• Delegation of Authority (DOA)
• Other Essential Records During the Trial

Understanding the components of a research protocol and effectively implementing it are critical for the successful execution of a clinical trial. In addition, the session will delve into the financial aspects of clinical trials, with a detailed exploration of site budgeting.

• What is a Protocol? – An introduction to the purpose and importance of a clinical research protocol.
• Protocol Development – Key steps and considerations in designing a protocol that meets scientific and regulatory standards.
• Sections of a Protocol – A breakdown of the essential components, including objectives, methodology, inclusion/exclusion criteria, and safety measures.
• Trial Budgeting – Insights into creating, negotiating, and managing budgets to ensure adequate funding and compliance with trial requirements.

Good Documentation Practices (GDP) serve as the cornerstone of reliable and ethical clinical research. High-quality documentation ensures that all trial data is collected accurately, contemporaneously, and in compliance with regulatory standards.

• What is GDP? – An introduction to Good Documentation Practices, their origin, and their role in clinical research.
• Regulations Governing GDP – Key regulatory frameworks that mandate proper documentation in global clinical research.
• Defining ‘Data’ in Clinical Trials – A detailed examination of what constitutes trial data and the nuances of its classification.
• ALCOA-C Principles and Their Additions – A thorough analysis of ALCOA-C standards (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
• Data Integrity and Governance – Best practices for maintaining data quality and integrity while preventing tampering or loss.
• Retention of Records – Strategies for preserving essential trial documents and meeting archival requirements.

Data Management Systems centralize clinical trial data for each protocol. Learn about data management systems and investigational product (IP) handling competency.

• Investigational Product Handling
• Interactive Web Response Systems
• Receipt & Storage of IP
• Study Compliance of IP
• Data Collection
• Case Report Forms (CRFs) & Electronic CRFs
• Electronic Data Capture
• Lab Portals
• Clinical Trial Management Systems
• Vendors

Adverse events and protocol deviations are prevalent in clinical trials, necessitating thorough documentation and reporting. This involves understanding their occurrences, conducting proper analysis, and implementing necessary follow-up actions.

• Adverse Events & Serious Adverse Events
• Recording AE’s & SAE’s
• Assessing Abnormal Results
• Reporting SAE’s
• Protocol Deviations
• Prevention Strategies for Deviations

Enrolling qualified participants is essential for assessing a product's safety and effectiveness. It involves recruiting and retaining research participants, along with using communication techniques that adhere to regulations.

• Recruitment Plans & Goals
• Estimating Enrollment & Study Population
• Recruitment Methods & IRB’s Role in Recruitment
• Advertisement Process Approval
• Diversity in Clinical Trials
• Pre-screening vs. Screening
• Recruitment Challenges
• Participant Retention Strategies
• Avoiding Undue Influence and Coercion
• Recruiting Do’s and Don'ts

This content covers investigator commitments for clinical research according to FDA Regulations and ICH GCP Guidelines.

• PI Oversight: Ensuring proper conduct of the clinical trial and protecting the welfare of participants.
• FDA Form 1572: Detailing the investigator’s agreement to comply with regulatory requirements and the approved protocol.
• Adherence to Good Clinical Practice (GCP): Maintaining data integrity, ethical standards, and participant safety.
• Handling Investigational Product (IP): Proper storage, documentation, and accountability for investigational drugs or devices.
• Reporting and Documentation: Timely reporting of adverse events, deviations, and maintaining complete, accurate trial records.

Clinical Trial Operations involve preparing, initiating, and supporting clinical trials. This session provides an outline of the operational steps throughout a trial’s lifecycle.

• Feasibility & Site Evaluation
• Study Award
• Contracts, Budgets, and Pre-Trial Documents
• Study Start-Up & Investigator Meeting
• Site Initiation Visit
• Running the Trial
• Interim Monitoring Visits
• Study Close-Out Visit

The informed consent process is a crucial component of clinical research practice. In this session, we will focus on the FDA guidance on the informed consent process, documentation, and ethical considerations.

• Regulations & Guidance
• Informed Consent Discussion
• Basic Elements of Informed Consent
• Documentation of the Informed Consent
• Newest Changes - Revised Common Rule
• Forms for Documentation
• Additional Elements of Informed Consent
• Considerations of Low Literacy & Disabilities
• Additional Changes
• Children Assent & Ethical Considerations

This session reviews basic procedures for collecting credible clinical research data.

• Blood Pressure & Heart Rate
• Documentation of Trial Procedures
• Lab Manual in Clinical Trials
• Electrocardiogram
• Centrifuge
• Pregnancy Test & Urinalysis
• Errors in Trial Procedure