Very few professionals working in clinical research or drug development have the opportunity to follow a clinical trial from design to closure. This seminar provides a broad overview of key aspects of conducting a clinical trial from the point of Good Clinical Practice (GCP).
This course provides an overview of the regulatory systems currently in operation and an understanding of the rationale for those systems.
Starting with the history of medicinal product regulations and the need for ethics, the course explains the regulatory aspects of clinical development and the purpose and impact of different regulations on the conduct of clinical research. Practical applications of GCP are explored including informed consent and safety reporting.
Delegates will receive a complimentary copy of the ICH-GCP guidelines.
This seminar is aimed primarily at those working in the biopharmaceutical industry. It is particularly suitable for anyone working in the following fields:
- Clinical Research
- Regulatory Affairs
- Drug Safety
- Research and Development
- Medical Sciences
On completion of this course you will have a clear understanding of the laws and regulations governing the conduct of clinical trials today and the significance and impact of Good Clinical Practice.
You will be fully aware of the roles and responsibilities of all parties involved in clinical trials, how they interact, and exactly what is required of them at each trial phase.
You will be familiar with the procedures for setting up a trial, requirements for site participation and exactly what happens at qualification and initiation visits, monitoring visits, audits and inspections. You will know about the quality assurance mechanisms for ensuring compliance, patient safety and data validity.
Introduction to clinical trials
- Aims of clinical trials
- Phases of clinical and epidemiological studies
- Milestones in clinical projects (design, implementation)
International ethical principles and guidelines
- History of and milestones in clinical research
- Nuremberg Code
- Declaration of Helsinki Good Clinical Practice (GCP) guidelines
- General principles of GCP
- ICH-GCP E6 (or regionally adapted GCP regulations)
Roles and responsibilities in clinical trials
- GCP responsibilities of the investigator
- GCP responsibilities of the sponsor and CRO
- GCP responsibilities of the monitor
- Standard Operating Procedures (SOP)
Applicable regional and/or national laws and guidelines
- Applicable regional and/or national drug laws and related guidelines
- Local requirements concerning the conduct of clinical trials
- Local requirements concerning the enrollment of subjects
- Organization of Ethics Committees and Regulatory Authorities
- Requirements of Ethics Committees concerning the conduct of clinical trials
- Local and country specific regulations (e.g. data protection, insurance)
- Label requirements
- Content of a protocol
- Inclusion and exclusion criteria
- Study procedures
- Informed Consent Form (ICF)
- Content of an ICF
- Informed Consent process
- Procedures and legal requirements for sensitive subject populations
- Investigator’s Brochure (IB)
Submission and approval processes
- Ethics Committees and Regulatory Authorities
- General information and composition
- Submission and approval process
- Which is the responsible IRB/IEC?
- Which is the responsible Regulatory Authority?
- Different types of investigational medicinal product
Site selection and pre-study visit
- Site recruitment strategies
- Feasibility studies
- Confidentiality agreement
- Aims of site pre-study visits
- Key documents at qualification
- Aims of site initiation visits
- Key documents and materials at initiation
- Electronic portals and tools
Monitoring and adverse event reporting
- Aims of site monitoring visits
- Case Report Forms and source data verification
- Study medication and drug accountability
- Safety reporting
- Investigator Site File Study
- Logistics of investigational medicinal products
- Labeling of investigational medicinal products
- Laboratory: central or local lab
- Aims of site close-out visits
- Regular or early termination: timelines
Audits and inspections
- Archiving audits and inspections
- Event-triggered vs. routine checks
- Sponsor inspections
- EMA / FDA and foreign authority inspections
- Audit preparation and training
- Behavior during audits and inspections
- Findings and consequences
- Inspection reports
To learn more about our in-house seminars and customized training options, or request a free proposal, contact us with information on the number of people to be trained, your preferred training location and your specific requirements.