Duration: 1 Day
Description
Medical Device Clinical Trials are very different to the more recognised form of clinical trials. Medical Device Trials are conducted under a different series of guidelines and directives and have different factors to address when compared to trials using investigative medicinal products (IMP). This course provides an understanding of these differences and details the various aspects of device trials.
This course will give delegates:
- understanding of relevant regulations
- background to the design of device trials
- insight into the operational aspects of these trials
Who is the course suitable for?
This course is suitable for anyone who is involved in clinical trials with medical devices. This includes:
- CRAs
- CTAs
- Study Nurses
- Investigators
- Data Managers
- Project Managers
- Clinical Trial Coordinators
- Ethics Committee Members
Example Content
Regulations for Medical Device Marketing in Europe
- Medical Device Directives
- CE Marking and Marketing of Devices
- Article 9 and Annexe IX: Classification of Devices
- Article 15 and Annexe X Clinical Investigations
- Annexe 1 Para 13.3 Labelling
- Competent Authorities and Notified Bodies
Clinical Trials with Medical Devices
- When is a Trial Required?
- Medical Device Trials Regulatory Requirements
- Notifications to MHRA
- Forms PCA1 and 2
- BS EN ISO 14155-1 Standard for the conduct of
Medical Device Trials in Humans.
- Definitions
- Outline
- Key requirements
- Document requirements
- Ethical considerations
- GCP – UK Directive – Relevance
Design of Medical Device Trials: Special Considerations
- Blinding and Randomisation
- Accountability
- Sterilisation
- Labelling
- Adverse Device Effects, Device Malfunctions
Reporting
- Device Training
Key Differences in Conducting Device Trials against IMP trials.
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