Clinical Research and Trial Management

Clinical research plays a crucial role in advancing medical knowledge and ensuring that new treatments are safe and effective. This course offers a structured introduction to how clinical trials are designed, managed, and monitored. It also introduces the regulatory, ethical, and operational aspects of clinical research in both academic and industry settings.

Whether you're new to the field or looking to expand your understanding, this training will help you grasp the essential concepts of clinical trial phases, protocol development, participant safety, data management, and regulatory compliance. It is a solid foundation for anyone interested in clinical research as a career or in supporting roles.

Section 1: Introduction to Clinical Research

• What is clinical research?
• Purpose and value of clinical trials.
• Differences between observational and interventional studies.
• Key stakeholders in clinical trials.

Section 2: Clinical Trial Phases

• Overview of Phase I, II, III, and IV trials.
• Purpose and timeline of each phase.
• Examples of trials in different phases.

Section 3: Trial Design and Protocol Development

• Core elements of a clinical trial protocol.
• Defining study objectives, endpoints, and methodology.
• Writing clear inclusion/exclusion criteria.
• Designing informed consent forms.

Section 4: Roles in Clinical Trial Management

• Principal Investigator (PI), Study Coordinator, CRA.
• Trial Sponsor responsibilities.
• Site selection and site initiation visits.
• Communication and documentation.

Section 5: Ethical and Regulatory Considerations

• Introduction to Good Clinical Practice (GCP).
• Institutional Review Boards (IRB) / Ethics Committees.
• Informed consent and participant rights.
• Reporting adverse events and maintaining transparency.

Section 6: Data Management and Monitoring

• Data collection methods (eCRF, paper-based, EDC systems).
• Data cleaning, validation, and analysis basics.
• Trial monitoring and quality control procedures.
• Common challenges in clinical data handling.

Section 7: Safety, Compliance, and Risk Management

• Pharmacovigilance overview and adverse event reporting.
• Managing protocol deviations and compliance issues.
• Audit readiness and inspection basics.
• Risk-based monitoring in clinical trials.

Section 8: Closing and Reporting

• Trial close-out procedures.
• Preparing the final study report.
• Publishing results and data sharing.
• Importance of transparency in clinical trials.

Upon successful completion of this training course, delegates will be awarded a Holistique Training Certificate of Completion. For those who attend and complete the online training course, a Holistique Training e-Certificate will be provided.

Holistique Training Certificates are accredited by the British Accreditation Council (BAC) and The CPD Certification Service (CPD), and are certified under ISO 9001, ISO 21001, and ISO 29993 standards.

CPD credits for this course are granted by our Certificates and will be reflected on the Holistique Training Certificate of Completion. In accordance with the standards of The CPD Certification Service, one CPD credit is awarded per hour of course attendance. A maximum of 50 CPD credits can be claimed for any single course we currently offer.