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