This training is a 2-day course, covering the following topics:
- Clinical Research, ICH-GCP and ISO14155. An Introduction
This section provides the high-level knowledge required for a proper understanding of the research related rules, responsibilities, interactions and jargon used. An introduction to research history and definitions, ethics, guidelines (ICH GCP – ISO14155) and regulations, clinical research in pharma, biotech and medical devices, trial roles and responsibilities will be provided in an interactive fashion.
- The Informed Consent Process, Quality Control and Protocol Compliance in Clinical Trials
Every year for at least the last 20 years, Informed Consent Form (ICF) issues and protocol compliance breaches are listed in the top 10 of most common EMA inspection findings. On top of this, in about 50% of the cases these findings are categorized as critical or major. If you want to avoid this kind of inspection feedback and ensure patient safety as well as quality of data for your trial, this training will set you well on your way.
- Safety Reporting, Investigational Product Handling and Monitoring in Clinical Trials
Subject safety and the collection of quality data are the key objectives in any legislation or guidelines related to clinical trials anywhere in the world. A proper understanding and execution of the safety reporting and Investigational Product (IP) handling process is therefore necessary to achieve these objectives.
- Documentation and (e)CRF Best Practices
In clinical research, we have a saying: ‘When it is not documented, it did not happen’. But how can we make sure we documented everything and done it as per applicable regulatory body expectations? Not an easy task, and we are here to help!
By the end of this TRIUM Training you should be able to:
- Define clinical trials
- Describe the therapy development process
- List the most important guidelines and regulations on a global scale for clinical trials
- List the various stakeholders in clinical trials and how they interact
- Explain the main sponsor, investigator and ethics committee responsibilities as per ICH GCP (R2) and ISO14155
- List the global legislation and guidelines regulating the ICF process, QC in clinical trials and protocol compliance
- Define and apply the ICF process in any clinical trial
- Define QC in clinical trials
- Conduct QC activities for your role in research like KPI and early warning indicator setting, compliance planning and trending
- Support your site in protocol compliance by applying the tricks and tips learned
- List the global legislation and guidelines regulating the safety reporting and IP handling procedures
- Define safety reporting definitions
- List the research stakeholders involved in safety reporting and IP handling
- Investigator, sponsor, applicable ethics and regulatory body responsibilities related to safety reporting and IP handling
- Monitoring responsibilities and activities to ensure qualitative safety reporting and IP handling
- Describe the safety reporting cycle and the difference between medical devices and pharma/biotech safety reporting processes
- Conduct compliant safety reporting and IP handling per your research role
- List the global legislation and guidelines regulating the document management and data handling procedure
- Prepare, manage and store the TMF for your clinical trial(s)
- Develop and/or review source documents and CRFs according applicable legislation expectations
- Conduct SDR and SDV activities that ensure compliance confirmation or early issue detection
- Share tips and tricks on quality document management
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.