NIS Considerations
CHCUK Newsletter March 2010
In this Month's Issue
Italy: Register of Obs Studies
Seminar: Practical Guide to PAS
NIS Resource: CIOMS Ethical Guidelines
India: Ethical Considerations for NIS




CHCUK Signpost
Welcome to the March 2010 edition of 'NIS Considerations'. 

This month we focus on recent updates to country-specific NIS guidelines in Italy, as well as, providing guidance on some NIS-related resources and training courses which you may find helpful.

Please feel free to contact me at any time if you have any comments or queries about the NIS Reports and our services.

Wishing you a Happy Easter,

Stuart McCully
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
Italy: Register of Obs Studies
Itay has launched a Register of Observational Studies (RSO)
Italian Flag

The Italian Regulatory Authority (AIFA) has launched a Registry for Observational Studies (RSO) which aims to gather prospective data on drug-related non-interventional clinical research.

The legal basis of the RSO is the "Guidelines for the Classification and Conduct of Observational Studies on Drugs" of 20 March 2008 (GUN 76, 31 March 2008).

The main objectives of the RSO are to:
  • Provide a descriptive analysis and publish periodic reports on the activities of observational research conducted in Italy
  • Support the activities of Ethics Committees
  • Provide guarantees to citizens and patients by improving the transparency, credibility and access to research.
Registration of studies is mandatory only for new applications (application/ notification paper) to Ethics Committees after the 1st March 2010.

RSO Website

Further Information:

Acknowledgements: Professor David Hutchinson of Brookwood International Academy and Canary Ltd

Seminar: Practical Guide to PAS
Brookwood International Academy is Running a 1 Day Practical Guide to Post-Authorisation Studies
Brookwood International Academy

Practical Guide to Post-Authorisation Studies: Requirements and Concepts

Organiser: Brookwood Academy

13 May 2010

Montgomery Suite, Chobham Golf Club, Chobham Road, Knaphill, Woking, Surrey GU21 2TZ, United Kingdom

Outline content
  • Regulations and guidelines affecting the conduct of post authorisation studies including the EFPIA guidance, Grace guidelines and Eudralex Volume 9a.
  • Comparison of GCP and Good Pharmacoepidemiology Practice (GPP), and when each is applicable.
  • Interactive sessions
    - to determine if case studies are interventional or not
    - the practical implications of setting up three different kinds of post-authorisation study
  • Types of PAS study
  • Special considerations for PASS -- post authorisation safety studies.
  • Issues relating to the  data management of PAS.
Click Here for the Full Seminar Programme

350 (ex VAT) for bookings received before 14 April 2010. 400 ex VAT thereafter. Discounts for groups can be negotiated.

To book your place contact: or telephone +44 1483 811383

NIS Resource: CIOMS Ethical Guidelines
CIOMS has released a 2009 Edition of their Ethical Guidelines for the Conduct of Epidemiological Studies
CIOMS Ethical Guidelines
CIOMS International Ethical Guidelines for Epidemiological Studies (2009)

This 2009 text supersedes the 1991 International Guidelines for Ethical Review of Epidemiological Studies. Its core consists of 24 guidelines with commentaries. A section outlines the historical background and the revision process, and includes an introduction, an account of earlier instruments and guidelines and a statement of general ethical principles. An Appendix lists the items to be included in a research protocol to be submitted for epidemiological research involving human subjects. Also included in the appendices is the World Medical Association's 2008 Declaration of Helsinki.

The Guidelines set forth ethical guidance on how epidemiologists - as well as those who sponsor, review, or participate in the studies they conduct - should identify and respond to the ethical issues that are raised by the process of producing this information.

Further information can be found on the CIOMS website.

The CIOMS Guidelines can be purchased directly through the following websites:

India: Ethical Considerations for NIS
General Ethical Considerations when Conducting NIS in India
Indian Flag
Admittedly, India is outside the scope of 'Europe' but nevertheless I've taken the liberty of providing you with some 'NIS Considerations' information as this is a country I receive alot of questions about.

If you are considering conducting NIS in India a good starting point would be the following two documents: