We've spent the summer hours creating an impressive portfolio of NIS eLearning modules and reports, which we're pleased to present to you in this edition of the NIS Considerations newsletter.

If you have any questions about the products or would like to see a demo then feel free to contact me.

Stuart McCully
CHCUK

Part 1 of the NIS Considerations (Europe) Reports has been updated to reflect the current considerations when conducting non-interventional studies in:

• Belgium
• Czech Republic
• France
• Germany
• Greece
• The Netherlands
• Poland
• Portugal
• Spain
• Sweden
• Switzerland

A complimentary copy has been emailed to everyone who has previously purchased the report.

 

If you haven't received your copy then please contact me as soon as possible so that we can ensure you have access the up-to-date information it provides.

 

 If you haven't done so already, and would like to purchase a copy of the report, you can do so via our online shop: http://www.chcuk.co.uk/shop/   

NIS Considerations Reports
CHCUK have developed NIS Considerations reports for the following countries:

• Argentina
• Australia
• Brazil
• Canada
• Israel
• Luxembourg
• Mexico
• Russia
• USA 

These reports provide a comprehensive overview of the country-specific regulatory and practical considerations when conducting non-interventional studies in these countries

The reports explores the Country-specific requirements when conducting non-interventional studies in Argentina and looks specifically at:

• Regulatory classification
• Regulatory framework/applicable legislation and guidelines
• Approval requirements
• Submission documents
• Approval timeframes
• Responsibilities
• Practical considerations
• Data privacy considerations
• Human tissue research considerstions

These report are much more comprehensive that the 'NIS Considerations - Europe' reports in that they provide operational details on the submission requirements, documents, and timeframes etc and so are an ideal operational guidance documents for anyone wishing to set up these types of study in the countries covered  

 

The reports can be purchased directly from our online shop: http://www.chcuk.co.uk/shop/   

 

Coming soon!
We are currently developing reports for the following countries, which will be available top purchase through our website in the coming months:

• China
• Japan
• India 
• Singapore
• South Africa
• Taiwan
• Tunisia
• Turkey  

CHCUK has developed a comprehensive portfolio of NIS eLearning modules that can be accessed through via the web using your PC, Mac, Smartphone, Tablet etc.  The country-specific courses are broken into bite-sized chunks and provide an ideal training environment for project managers and CRAs.

Refer to:

• CHCUK Online Courses 

Please feel free to contact us for more information and a free demo.  Please note that group discounts are available on request.

NIS eLearning Courses 

Each NIS Considerations course provides a comprehensive overview of the country-specific regulatory and practical considerations when conducting non-interventional studies in the selected country  

 

 

eLearning Modules
The CHCUK eLearning portfolio currently captures the NIS requirements for the following countries:

1. Argentina
2. Austria
3. Australia
4. Belgium
5. Brazil
6. Canada
7. Croatia
8. Czech Republic
9. Denmark
10. Finland
11. France
12. Germany
13. Greece
14. Hungary
15. Ireland
16. Israel
17. Italy
18. Luxembourg
19. Mexico
20. Norway
21. Poland
22. Portugal
23. Russia
24. Slovenia
25. Spain
26. Sweden
27. Switzerland
28. The Netherlands
29. UK
30. USA

 

Course objectives:
The course aims to explain the practical considerations and challenges when conducting non-interventional studies in the selected country

 

Course outline:
Each course consists of 1 module and includes a certificate of completion.  It is estimated that each course will take 30 minutes to complete.

Module 1: Explore the Country-specific requirements when conducting non-interventional studies in the selected and looks specifically at:

• Regulatory classification
• Regulatory framework/applicable legislation and guidelines
• Approval requirements
• Submission documents
• Approval timeframes
• Responsibilities
• Practical considerations
• Data privacy considerations
• Considerations when collecting, storing and analysing human tissue 
• Industry best practice 

Course Format:

• Includes reminders at the end of each module
• Has an audio commentary
• Includes comprehensive supporting tools and resources
• A certificate of completion is issued to all participants who complete the course

 

Course Benefits:

• The course material will be updated as soon as changes occur to the applicable guidelines and materials.  If you are assigned to the course then you will automatically be notified of changes
• The course material provides excellent training material for those who haven't conducted NIS in the country selected, or refresher training for those who have
• The course materials provide excellent regulatory and operational reference sources
• Course certificates can be adapted to company-specific requirements
• Bespoke progress and status reports can be generated at no extra cost
• Annual subscriptions allow access to all courses for an unlimited number of employees - thus providing a consistent NIS training platform and mitigates for knowledge loss due to staff turnover