Course Objectives

  • Equip participants with the knowledge and skills required to work as a CRA in clinical trials.
  • Provide practical understanding of essential tools, processes, and compliance standards.
  • Prepare participants for real-world responsibilities, including site visits, monitoring, and document management.

Module 1: Introduction to Clinical Research

  • Overview of clinical research and its phases (Phase I–IV).
  • Key roles and responsibilities of a CRA.
  • Introduction to regulatory bodies (FDA, EMA, ICH, etc.) and guidelines (ICH-GCP).
  • Understanding clinical trial protocols and standard operating procedures (SOPs).

Module 2: Regulatory Compliance and Ethics

  • Principles of Good Clinical Practice (GCP).
  • Informed Consent Process: Ensuring participant safety and ethics.
  • Regulatory submissions and essential documents (e.g., Investigator Brochure, Protocol, etc.).
  • Ethical considerations and managing adverse events.

Module 3: Trial Master File (TMF) Management

  • Purpose and structure of the Trial Master File.
  • Essential documents for TMF and their management.
  • Best practices for maintaining an audit-ready TMF.
  • Ensuring compliance with regulatory and sponsor requirements.

Module 4: Clinical Site Selection and Initiation

  • Feasibility studies: Selecting suitable sites for clinical trials.
  • Preparing for site initiation visits (SIVs).
  • Conducting investigator and site staff training.
  • Creating site-specific plans for trial implementation.

Module 5: Site Monitoring and Management

  • Preparation for Monitoring Visits
    • Pre-visit planning and documentation review.
    • Communication with site staff before visits.
  • On-site Monitoring Visits
    • Source Data Verification (SDV) and Source Data Review (SDR).
    • Ensuring protocol adherence and regulatory compliance.
    • Identifying and resolving deviations and issues.
  • Post-Monitoring Activities
    • Writing clear and concise monitoring visit reports.
    • Follow-up on action items and CAPA (Corrective and Preventive Actions).
  • Remote monitoring techniques and technologies.

Module 6: Data Management and Reporting

  • Understanding Case Report Forms (CRFs) and eCRFs.
  • Handling missing data, discrepancies, and query resolution.
  • Ensuring data integrity and confidentiality.
  • Preparing for interim analysis and final trial closeout.

Module 7: Risk-Based Monitoring (RBM)

  • Introduction to RBM principles and implementation.
  • Identifying critical data and key risk indicators (KRIs).
  • Tools and technologies for effective RBM.
  • Balancing remote and on-site monitoring activities.

Module 8: Closeout Activities and Study Archiving

  • Conducting closeout visits at clinical sites.
  • Ensuring proper storage of essential documents and data.
  • Preparing final reports and regulatory submissions.
  • Best practices for long-term archiving of clinical trial materials.

Module 9: Soft Skills for CRAs

  • Effective communication and conflict resolution with site staff.
  • Time management and organizational skills.
  • Building strong relationships with investigators and site teams.
  • Presentation skills for sponsor and team meetings.

Module 10: Certification Examination and Final Assessment

  • Comprehensive knowledge check (multiple-choice and scenario-based questions).
  • Practical case studies and simulations (e.g., monitoring visit scenarios, SDV/SDR exercises).
  • Feedback and guidance for improvement.
  • Final certification issued upon successful completion.

Additional Resources

  • Access to NBScience eLearning® platform with mandatory and optional content.
  • Sample templates for monitoring reports, CAPA plans, and other key documents.
  • Case studies and real-world examples from clinical trials.
  • Networking opportunities with industry professionals and recruiters.

Outcome:
Upon successful completion, participants will receive an internationally recognized CRA Certification. They will be well-equipped to perform site monitoring, manage essential documents, ensure compliance with regulations, and contribute effectively to clinical research projects.

For Enrollment and More Details: head_office@nbscience.com

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