Clinical Training = Quality
The quality of the Clinical Investigation Trial data is largely dependent on the knowledge of the contributors. Training of sponsor personnel and participating clinical trial sites is essential in establishing a higher than average understanding of applicable laws, regulations and standards which, in turn, results in a higher level of compliance.
What do we have to offer?
TRIQ offers several dedicated trainings for regulatory compliance and clinical operations.
Good Clinical Practice (GCP) Training
EN ISO 14155 GCP training for Investigators, Study Staff and/or Sponsor
Our GCP training is recognised by the Federal Physicians Chamber (BÄK) and all Ethics Committees.
GCP Training Content
- Ethical principles for clinical trials
- Overview of and introduction to the national and international regulations including 2017/745 EU MDR.
- Methodical basics for Medical Device classification, CE marking, CA & EC application and approval processes.
- Planing, Preparation and Conducting a clinical trial according to national and international laws & regulations
- Vigilance in clinical trials.
Where are the trainings given?
The GCP training can be conducted at TRIQ or as an in-house training on site and can be combined with a site initiation visit reducing the time and cost required for an off site training.
Clinical Medical Device Training
Investigational Medical Devices require additional training to ensure safety, correct use and compliance.
TRIQ can assist the sponsor to prepare or can conduct these trainings on behalf of the sponor for study personnel at the clinical sites.
In the case of an invasive procedure involving the Medical Device, TRIQ can also train the intervention team on the Medical Device, correct use, procedure and protocol related requirements.
All training will adhere to your applicable IFU and CIP.