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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. It is therefore essential to attend the whole course and certificates will not be issued to late comers.

 

Pricing Information:

Free to all NHS and University Staff	Free
Commercial Organisation	£180

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	To pay for courses please send a purchase order number along with name and date of course, name of attendee and email to ggc.glasgowcrfeducation@nhs.scot

Please note confirmation of course will be sent once a purchase order number has been provided.

Pay by Card

Please contact our Treasury Department with the name of course and course date - 0141 278 2794

The aim of this workshop is to equip clinical research staff with an understanding of the key elements involved in conducting a clinical trial of an investigational medicinal product (CTIMP). The course builds on GCP knowledge and assumes GCP training has been completed prior to attendance.

The workshop will consist of a mixture of presentations, case studies and practical exercises.  It is relevant to those who are new to research and for those who would like to improve their understanding of clinical trials involving an investigational medicinal product

After the Workshop, each Participant will:

• Understand relevant CTIMP terminology and the requirements for CTIMPs including permissions and approvals 
• Demonstrate the use of a protocol in setting up a CTIMP and planning a study visit
• Describe the key issues that impact on recruitment and retention
• Describe the key elements relating to the management of the investigational medicinal product (IMP) 
• Recognise the importance of accurate documentation throughout all trial-related activities
• Understand the importance of safety measures and parameters in CTIMPs and the responsibilities of the research team in monitoring these

Pricing Information:

NHS Greater Glasgow and Clyde, NHS Lanarkshire, NHS Dumfries and Galloway, NHS Waiting Times Centre, NHS Ayrshire and Arran	Free
Other NHS	£80
University	£120
Commercial Organisation	£290

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	To pay for courses please send a purchase order number along with name and date of course, name of attendee and email to ggc.glasgowcrfeducation@nhs.scot

Please note confirmation of course will be sent once a purchase order number has been provided.

Pay by Card

Please contact our Treasury Department with the name of course and course date - 0141 278 2794

This is a three day induction course aimed at providing knowledge and practical skills to new clinical staff to clinical research.

Continuing on from our introductions to clinical research, this course will look at data collection, protection and confidentiality as well as safety in clinical trial.  A session on site file maintenance includes how to set up a site file and where to file essential documents.

Pricing Information:

NHS Greater Glasgow and Clyde, NHS Lanarkshire, NHS Dumfries and Galloway, NHS Waiting Times Centre, NHS Ayrshire and Arran	Free
Other NHS	£80
University	£120
Member of public	£150
Commercial Organisation	£290
Bespoke course delivery	£950

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	To pay for courses please send a purchase order number along with name and date of course, name of attendee and email to ggc.glasgowcrfeducation@nhs.scot