NIS Considerations
CHCUK NewsletterApril/May 2010
In this Month's Issue
NIS Report (Part 1): 2nd Edition
NIS Report (Part 1): Advertising Opportunity
UK: Data Protection Audits
EFGCP Reports: 2010 Updates
Turkey: New Guidance Document
Germany: 2009 Update to the FSA Code of Conduct Published.
Switzerland: VKlin Amended




CHCUK Signpost
We've recentlly assessed the frequency of the NIS newsletters and have decided to move to a bi-monthly publication. So the next installment will be due in June 2010.

However, please rest assured that we will inform you as soon as possible of any news and/or updates that are time critical and require your immediate attention.

Best wishes,

Stuart McCully
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
NIS Report (Part 1): 2nd Edition
Part 1 of the NIS Report will be updated and re-released in August 2010
NIS Part 1
In the next few weeks we will start the process of updating the first of the NIS Reports (Part 1) so now is the ideal time to provide us with your wish list of items you would like to see covered in the 2nd Edition of the report.

If there is somethine specific you would like to see added to the report please contact me at  I can't guarantee that your request will be incorporated into the report but I can guarantee that we will give it serious consideration.

The report will be provided free of charge to all who have previoulsy purchased a copy.
NIS Report (Part 1): Advertising Opportunity
We are adding a hyperlinked 'Service Providers' Section to the Report(s).  Please Contact Us if You Would Like to Take Advantage of this Advertising Opportunity
Road to Success
We will be adding a new 'Service Providers' section to each country after the 'Useful Links' section of the NIS Report. The intention is to provide users with convenient access to NIS-related service providers in each of the countries provided. 

If you would like to take advantage of this advertising opportunity please contact me at or +44 (0) 1997 42 33 11 to discuss the nominal fee, format etc.
UK: Compulsory Data Protection Audits
The UK's ICO is publishing a Code of Practice to Capture the Extended Data Protection Audit Powers it Now Has under the Coroners and Justice Act 2009

The Information Commissioner is responsible for enforcing and promoting compliance with the
Data Protection Act 1998.

The Information Commissioner's Office (ICO) will have the power to audit government departments without their UK Imageconsent from April 2010. The move follows the passage of the Coroners and Justice Act on 12 November 2009.

This new power can also be extended to other public and private sector organisations but only following a 'designation' process. The ICO must first serve an assessment notice. An 'assessment notices' code of practice, covering areas such as the circumstances in which a notice can be served, the nature of the assessment process and the publication of assessment reports will follow shortly.

The Code will provide the framework for how audits will be conducted when an Assessment Notice has been served on an organisation. It will outline the approach to the audit including opportunities for consultation in relation to the audit report findings and recommendations.

With these new powers the ICO will be better placed to provide assurance to individuals that those holding their personal information respect their privacy and do not abuse their trust.

Data controllers will be informed in writing of the Information Commissioner's intention to cond
Data Privacy
uct an audit. This letter will explain the audit process, the basis on which they have been selected and a broad outline of the intended scope and the projected dates of the various audit activities.

Audit Process
Audits undertaken by the Information Commissioner will be conducted in two phases; an 'adequacy audit' and a 'compliance audit'.

The 'adequacy audit' will normally be conducted off site and will consist of a review of relevant policies, procedures, guidance and training material. The key consideration will be how these documents provide a framework for delivering compliance with the Act; any significant findings will be detailed in the Audit Report. These documents and the output from the review will provide the framework for the 'compliance audit'

The 'compliance audit' will be focused on the agreed scope and conducted on the data controller's site(s) over a number of days. Evidence of compliance with the Act, the following of good practice and adherence to policies will be gathered through meetings with staff and the observance of personal data handling processes.

The findings of the Audit will be documented in an Audit Report with opportunities provided for the data controller to comment on accuracy and respond to the recommendations. Informal feedback on findings may also be provided during the course of the audit.

Assessment Notices
Assessment Notices will be served where it is deemed necessary by the Information Commissioner because:
  • a risk assessment has been conducted and indicates a high probability that personal data is not being processed in compliance with the Act with a significant likelihood of damage and distress to individuals, and
  • the data controller has failed to respond to a written request from the Information Commissioner to undertake an audit or has refused consent to such an audit, without adequate reasons.
For more information please refer to the:
EFGCP Reports: 2010 Updates
The EFGCP Reports on the REC Approval Process for Clinical Research Protocols in the EU have been updated

EFGCP Report
Readers are refered to the EFGCP Report on the 'Procedure for Ethical Review of Protocols for Clinical Research in the European Union' which was updated in April 2010.

The Report identifies the ethical review process is for each member state, plus Norway and Switzerland, and is an invaluable reference document for any company, academic department or contract research organisation wishing to conduct clinical research anywhere in Europe.
Turkey: New Guidance Document
The IEGM has published a New 'Guidance on Observational Studies with Drugs'
Flag of Turkey

In April 2010, the Turksih General Directorate of Pharmaceuticals and Pharmacy (IEGM) published a new comprehensive  'Guidance on Observational Studies with Drugs'.

As a result, the "The Guidance Regarding the Planning, Conduct and Evaluation of Observational Studies Performed with Drugs", enforced with the Ministerial approval dated January 22, 2008, with No. 433, has been revoked.

Germany: 2009 Update to the FSA Code of Conduct Published
The 2009 Update to FSA Code of Conduct on the Collaboration with Healthcare Professionals has been Published
German Flag
The FSA Code of Conduct on the Collaboration with Healthcare Professionals, refered to as the 'FSA COP' in the NIS Reports was updated amended on 27 November 2009 and announced in the Federal Gazette of 10 February 2010.  As a result, the links provided in the report will no longer work so please refer to, and bookmark, of the following link.
There appears to be no major impact on, or addition to, the requirements for the conduct of NIS in Germany.

Readers may also be interested in Section 2 of the vFA Code of Ethics (2008).  Please note that this is only available in German.
Version 2 of the INFARMA COP was Published in 2009
Polish Flag
Please note that version 2 of INFARMA's "PHARMACEUTICAL INDUSTRY
ORGANISATIONS" (the INFARMA COP 2009) was released after the publication of Part 1 of the NIS Report.

Readers are therefore referred to the most current version of the INFARMA COP 2009.

Differences from the previous COP include the:
  • Addition of two new sub-Articles (Articles 10.12 and 10.13) which deal with 'general principles of advertisingand promotion'
  • Re-formatting of Article 19 and addition of Article 19.2 which deals with 'statements in advertisements'
There appears to be no major impact on, or addition to, the requirements for the conduct of NIS in Poland.
Switzerland: VKlin Amended
The Ordinance on Clinical Trials with Medicinal Products (VKlin) has been Amended
Swiss Flag (2)
The Ordinance on Clinical Trials with Medicinal Products (VKlin) has been amended with effect of 1 April 2010.  There is currently no English translation available,

The following Articles have been amended:
  • Article 4 (International guidelines)
  • Article 14 (Clinical trials - supporting documentation)
  • Article 24 (Reporting serious Incidents with medical devices)
  • Article 25 (Clinical trials - storage requirements)
There appears to be no major impact on, or addition to, the requirements for the conduct of NIS in Switzerland.

For those prospective non-interventional studies that do not fit within the definition provided in Article 37 of the SGCI COP, Sponsors are advised to contact swissmedic before starting the study.

Swissmedic will clarify the classification of the prospective NIS and determine whether it falls under the scope of VKlin.  If it does, the study would be classed as a Phase 4 clinical trial.