Welcome 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.
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,
- Tansparency throughout the research process,
- Thereby promoting scientific independence of such studies.
The objectives of the Checklist of Methodological Research Standards are:
Anyone interested in submitting comments should:
- 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.
Sweden: Change of Address
New address of the Swedish Central Ethical
From 1 November 2009 the new
address of the Swedish Central Ethical Review Board is:
Central Ethical Review Board
c / o Research Council
101 38 Stockholm
Sweden: Broken Links
Borken Hyperlinks in Part 1 of the NIS Report
The hyperlinks to the following documents are
broken in Part 1 of the NIS Report
Corrected hyperlinks and further information are included belowEthical Review of Research
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)
concerning the ethical vetting of research involving humans (as amended by
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;
Statute (2007:1068) for the Central Ethical Review Board.
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
|Data Protection: Sweden
Notification to the Supervisory Authority (The Data Inspection Board)
According to Section 36 of the Personal Data Act (1998:204
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
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
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
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
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
when Managing and Conducting Non-Interventional Studies in the UK
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).
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
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.
BfArM Guidance on Non-interventional studies ("Anwendungsbeobachtungen" or "AWB")
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?
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.
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
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?
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?
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).