NIS Considerations
CHCUK Newsletter December 2009
In this Month's Issue
ENCepp Public Consultation
Sweden: Change of Address
Sweden: Broken Links
Data Protection: Sweden
Data Protection: Belgium
NIS Report (Part II): Now Available
NIS Considerations: UK
Germany: AWB

CHCUK

Greetings!

Nativity - SoliheteWelcome to the Christmas addition of our 'NIS Considerations' newsletter. 
 
We hope that this newsletter finds you well and wish you a happy Christmas and a peaceful and productive New Year.
 
Sincerely,
Stuart McCully
CHCUK
 
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
email: stuart.mccully@chcuk.co.uk


ENCePP Public Consultation
Consultation on the ENCePP Code of Conduct and the Checklist of Methodological Research Standards is open until 5 January 2010


On 16 November 2009, the European Medicines Agency (EMEA) released for public consultation a draft Code of Conduct for Independence and Transparency, and a draft Checklist of Methodological Research Standards that lay down key elements and principles for the conduct of "European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Studies".

The objectives of the ENCePP Code of Conduct are to provide a set of rules and principles for Pharmacoepidemiology and Pharmacovigilance studies as regards:
  • Best practice in the relationship between investigators and study funders, including protocol agreement and publication of results, and
  • Tansparency throughout the research process,
  • Thereby promoting scientific independence of such studies.

The objectives of the Checklist of Methodological Research Standards are:
  • to stimulate researchers  to consider important epidemiological principles when designing a pharmacoepidemiological study and writing a study protocol;
  • to promote transparency regarding methodologies and design used in pharmacoepidemiological studies performed in the EU;
  • to increase awareness about developments in science and methodology in the field of pharmacoepidemiology.
Anyone interested in submitting comments should:
 
Sweden: Change of Address
New address of the Swedish Central Ethical Review Board
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From 1 November 2009 the new address of the Swedish Central Ethical Review Board is:

Central Ethical Review Board
c / o Research Council
Box 1035
101 38 Stockholm
 
Sweden: Broken Links
Borken Hyperlinks in Part 1 of the NIS Report
Broken Chain
The hyperlinks to the following documents are broken in Part 1 of the NIS Report:
  • The Act concerning the Ethical Review of Research Involving Humans (2003:460)
  • The MPA's Provisions and Guidelines on Clinical Trials of Medicinal Products for Human Use (LVFS 2003:6)
  • Statute (2003:615) concerning the ethical vetting of research involving humans (as amended by Ordinance 2008:351)

Corrected hyperlinks and further information are included below

Ethical Review of Research

  • The Act concerning the Ethical Review of Research Involving Humans (2003:460);
  • The Statute (2003:615) concerning the Ethical Review of Research Involving Humans; 
  • The Statute (2007:1069) with instructions for Regional Ethical Review Boards;
  • The Statute (2007:1068) for the Central Ethical Review Board. 

Source: http://www.epn.se/start/regulations.aspx

Provisions and Guidelines on Clinical Trials of Medicinal Products for Human Use

  • The MPA's Provisions and Guidelines on Clinical Trials of Medicinal Products for Human Use (LVFS 2003:6)
Opens the 'Clinical Trials' page of the MPA.  The link to LVFS 2003:6 can be found on the right hand of the page

Source: http://www.lakemedelsverket.se/english/product/Medicinal-products/Clinical-trials/

Data Protection: Sweden
General Considerations
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Notification to the Supervisory Authority (The Data Inspection Board)

According to Section 36 of the Personal Data Act (1998:204), Processing of personal data that is completely or partially automated is subject to a notification duty. The controller of personal data shall provide a written notification to the supervisory authority before such processing or a set of such processing with the same or similar purpose is conducted.

If the controller of personal data appoints a personal data representative, this shall be notified to the supervisory authority. Removal from office of a personal data representative shall also be notified to the supervisory authority.

The Government or the authority appointed by the Government may issue regulations concerning exemptions to the notification duty under the first paragraph for such kinds of processing as would probably not result in an improper intrusion of personal integrity.

Notification need not be made if there is a Personal Data Representative

According to Section 37 of the Personal Data Act (1998:204), notification under Section 36, first paragraph, need not be made if the controller of personal data has given notice to the supervisory authority that a personal data representative has been appointed and who he/she is.

Personal Data that are Handled within the Scope of Clinical Trials

Personal data that are handled within the scope of clinical trials of medicinal products must be treated in compliance with the regulations established in the Personal Data Act (Personal Data Act (1998:204)). This implies that the treatment of such personal data as a rule should be notified to the Swedish Data Inspection Board. In the Personal Data Ordinance (Personal Data Ordinance (1998:1191)) there is also the requirement that the processing of certain integrity-sensitive personal data must be notified to the Data Inspection Board for control in advance. This concerns treatment of personal data regarding genetic predisposition that appear in a genetic study. If such personal data are handled within the scope of a clinical trial a notification must be made to the Data Inspection Board for control in advance regardless of whether the Ethics Committee (EPN) has reviewed and given a positive opinion of the study, and regardless of whether the persons participating in the trial have given their informed consent (as per the Guidelines to Chapter 3.3 of LVFS 2003:6).
 
Data Protection: Belgium
Notification to the Supervisory Authority (CPP)

According to Article 17 of the Act of 8 December 1992 on the protection of privacy in relation to the processing of personal data (Privacy Act or Data Protection Act - as amended), prior to any wholly or partly automatic operation or set of operations intended to serve a single purpose or several related purposes, the controller or his representative, if any, must notify the Commission for the Protection of Privacy (CPP).

 
NIS Report (Part II)
Part 2 of the NIS Report is Now Available
NIS Part II

You'll be pleased to know that Part II of the NIS Report is now available.

The report continues on from Part I and summarises the considerations for conductign and managing non-interventional studies in a further 17 countries:

Austria, Bulgaria, Cyprus, Denmark, Estonia, Finland, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Romania, Slovakia, Slovenia and the UK.
 
The report covers information such Regulatory Bodies (Competent Authority, Ethics Committee(s), Data Protection Agency), Self-Regulatory Bodies (e.g., ABPI) and applicable codes of practice, guidelines and regulations. 

More focus has been plcaed on the data protection element in this report.
NIS Considerations: UK
Considerations when Managing and Conducting Non-Interventional Studies in the UK
UK Image
In the UK, NIS are controlled by a combination of legislation and codes of practice.  Non interventional studies do not require authorisation by, or notification to, the MHRA (MHRA Website - Clinical trial authorisations: Is a clinical trial authorisation required?). However, the favourable opinion from an NHS research ethics committee (REC) is required before starting a non-interventional study (as per the NRES SOPs and the Department of Health Research Governance Framework).

Non-interventional Trials

Trials of medicinal products which are "non-interventional" are not classified as clinical trials of investigational medicinal products (CTIMPs) by the UK RECs and therefore  do not require review by a recognised REC.  Instead, they should be allocated for REC review in accordance with the normal procedures for non-CTIMPs (Paragraph 1.14 of NRES SOP, Version 4, April 2009).

Non-Interventional Trial or Audit etc?

Some projects within the definition of a "non-interventional trial" might be deemed not to be research at all, but rather clinical audit, service evaluation or some other type of non-research activity such as post-market surveillance.  If so, they would not require ethical review by a NHS REC or permission for research under the Department of Health Research Governance Framework; the NHS care organisation will have other procedures in place for agreeing to activity of this kind, for example review under clinical governance frameworks.  The NRES leaflet, "Defining Research", provides guidance on distinguishing between research, audit and service evaluation.

Further information is available in Part 2 of the NIS Report.
 
Germany: AWB
BfArM Guidance on Non-interventional studies ("Anwendungsbeobachtungen" or "AWB")
BfArM
How are clinical trials using investigational medicinal products distinguished from open post-marketing observations?

As a rule, open post-marketing observations are non-interventional trials which meet the requirements of Section 4 sub-section 23 sentence 3 of the German Medicines Act (Arzneimittelgesetz, AMG). This reads: "A non-interventional trial is a study, in the context of which findings resulting from persons' treatment with medicinal products pursuant to the specifications for use contained in the marketing authorisation are analysed using epidemiological methods; the treatment, including the diagnosis and monitoring shall not follow a predetermined trial protocol but shall result exclusively from current medical practice."

Which documents are necessary for the submission of a non-interventional trial pursuant to Section 67 sub-section 6 of the German Medicines Act?

In accordance with Section 67 sub-section 6 of the German Medicines Act (AMG), the pharmaceutical entrepreneur shall immediately give notice to the Federal Panel Doctors' Association, to the central associations of the statutory health insurance funds, as well as to the national competent authority of tests which serve the purpose of gathering knowledge on the application of authorised or registered medicinal products. In this connection, the location, time, and purpose of the non-interventional study shall be stated together with the names of the participating doctors.

Compensations given to doctors for their participation in tests in compliance with sentence 1, shall qualitatively and quantitatively be set in a way that no incentive will arise for a preferential prescription or recommendation of particular medicinal products. In so far as participating doctors render services debited to the statutory health insurance, in notifications in compliance with sentence 1, the quality and quantity of the compensations given to the doctors shall also be stated. In addition, a copy of the contracts concluded with the doctors shall be transmitted. Notifications to the national competent authorities are exempt from this regulation.

Is there an official form for notification of non-interventional studies?

At present, there is no official form; the notification of a non-interventional trial to the competent authority should be submitted informally.
When does a non-interventional trial in accordance with Section 67 sub-section 6 of the German Medicines Act have to be notified?
The notification must be submitted prior to the commencement of the non-interventional trial. Only the participating doctors, the time, location, and purpose of the non-interventional trial shall be stated.

Is the non-interventional trial limited to a particular number of patients per doctor or to a particular number of doctors?

There is neither a limitation to a particular number of patients per doctor nor a limitation to a particular number of doctors.

Is the Announcement on the Authorisation and Registration of Medicinal Products - Recommendations for Design and Conduct of Observational Post-authorisation Safety Studies dated 12 November 1998) still up-to-date?

The Recommendations for Design and Conduct of Observational Post-authorisation Safety Studies dated 12 November 1998 are no longer up-to-date in their present form, since several parts lack consistency with the current legal situation. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) and the Paul-Ehrlich-Institute (PEI) have jointly elaborated recommendations on the conduct, design, and analysis of non-interventional trials. The new concerted recommendations will replace the former recommendations of the BfArM dated 12 November 1998 (Federal Gazette No. 229, page 16884, dated 4 December 1998).

Source: http://www.bfarm.de/cln_012/nn_425174/SharedDocs/FAQ/EN/Functions/drugs/clinTrials/klinik/3anw-beobacht/faqClinTrials-klinik-anw-beobacht-table.html
 

CHCUK