Course Browse

This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or those who have studied it more than two years ago. It is presented as a practical introduction to the subject and consists of a mixture of short lectures interspersed with practical activities, culminating in a monitoring workshop. The monitoring workshop allows the more abstract concepts that have been discussed throughout the day to be brought to life.

While the principles of GCP that are covered in the course are common to a wide range of different types of clinical research the course does focus on the drug trial specific legislation. However, it also promotes the ‘GCP-mindset’ needed to satisfy inspectors and auditors, and would therefore be useful for all clinical researchers.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors. 

 

Pricing Information:

Commercial Organisation	£210
University	Free

Invoice Detail:

Name	NHS GREATER GLASGOW AND CLYDE
Building	CALEDONIA HOUSE
Street	CARDONALD BUSINESS PARK
City	GLASGOW
Postcode	G51 4ED
Subject	ENDOWMENT FUND CG0337 EDUCATION AND TRAINING
Detail	Please provide details of the training course, date and name of attendee on the purchase order and email copy to GG-UHBGlasgowCRFeducation@nhs.net.

This course is relevant for those who are conducting or supporting Clinical Trials of an Investigational Medicinal Products (CTIMPs) and who have previously undertaken a GCP course. It is suitable for those who require an update to provide evidence of having maintained and updated their knowledge of GCP. Attendance at the half day update course requires you to have undertaken GCP training within the past two years. The course is compliant with Transcelerate requirements.

Topics include:

• UK legislation – Statutory Instrument
• What’s new in regulations and frameworks
• Quality Systems
• Record Keeping
• Safety Reporting
• Computer System Validation
• Principles of GCP.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Pricing Information:

Commercial Organisation	£110
University	Free

Invoice Detail:

Name	NHS GREATER GLASGOW AND CLYDE
Building	CALEDONIA HOUSE
Street	CARDONALD BUSINESS CENTRE
City	GLASGOW
Postcode	G51 4ED
Subject	ENDOWMENT FUND CG0337 EDUCATION AND TRAINING
Detail	Please provide details of the training course, date and name of attendee on the purchase order and email copy to GG-UHBGlasgowCRFeducation@nhs.net.