GCP Training
All clinical trials must adhere to Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that the clinical trial data and reported results of clinical investigations are credible and accurate.
The NIHR provide comprehensive GCP resources including templates and documents to help develop quality systems.
The new Medicines and Medical Devices Act 2021 requires compliance with GCP guidelines. Staff involved in any aspect of clinical trial work need to be suitably qualified to ensure that they comply with GCP. This also includes support departments.
There is no formal GCP qualification so it is essential for individuals to keep up to date records of their GCP education and training activity.
GCP training for University of Manchester employees can be obtained from:
For researchers involved in clinical investigations of a medical device, the following standards -which are freely available through the library - will apply:
ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 14971:2019 - Medical devices – Application of risk management to medical devices
ISO 20916:2019 - In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
ISO/IEC 27001:2022 - Information security, cybersecurity and privacy protection – Information security management systems
ISO 9001:2015 - Quality management systems – Requirements
ISO 15189:2022 - Medical laboratories – Requirements for quality and competence
ISO 22301:2019 - Security and resilience – Business continuity management systems