How often do you need to complete GCP training?
This is decided by the NHS Trust you work in/ your employer, as the answer depends on the specific clinical trial you are involved in and your professional expertise. Institutions may set their own standards for the frequency of GCP training for Clinical Investigators and their staff. However, the regulations and the MHRA require that all staff is trained to carry out their duties on each study they are working on. Each time when there is an update in the legislation, everyone must get familiar with it and implement it in their working activities.
Training Objectives:
By using an original approach based on extensive feedback from experience, this training course aims to satisfy the following objectives in the specific context of Good Clinical Practice:
- Understand the MHRA regulatory requirements of Good Clinical Practices (GCP), or “Why and when GCPs must be implemented”
- Understand the ethical requirements: definition of ethics, the underlying principle of clinical tests. What are the practical consequences? Learn ethical requirements at national and international levels. Learn how to protect the volunteer (health, protection of privacy (personal data, confidentiality) etc.)
- Understand the key functions in GCP organisation: The role of the investigator, promoter, monitor.
- Learn how to set up a clinical study and how to ensure that GCPs are complied with, that the data are efficiently collected, etc.
Training Agenda:
- Brief summary of the purpose and principles of GCP
- Overview of the UK Legislation & Responsibilities in Clinical Trials
- The EU Clinical Trial Directive
- Introduction to Safety & Adverse Event Reporting – Definition, identification, documentation, reporting and follow-up
- Obtaining Informed Consent
- Trial master file and Essential Documentation
- MHRA – Purpose of Monitoring, Auditing & Inspections
- Case Study
- Q&A Session
Who Should Attend?
- Clinical research professionals in the pharmaceutical and biopharmaceutical
- industry, clinical research organizations, and research institutions.
- Investigators
- Clinical Trials Support Staff (e.g staff working in CROs)
- Clinical Research Asociates
- Clinical Research Coordinators
- Clinical Research Management Staff (Project Managers , Medical Directors, , etc)
- Graduates looking to develop a career in clinical research
- Everyone who is interested in networking with other clinical research professionals
Fee:
59 EUR
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Dates of Session:
To be confirmed
Technical Information:
Session will be conducted on-line via a web meeting. Each participant will receive a unique user ID and login to access the session.
