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This page provides answers to the most frequently asked questions about ENCePP and its key principles.
You may also be interested in: Frequently asked questions - EU PAS Register
If the answer to your question is not here, please email us at encepp_secretariat@ema.europa.eu
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network coordinated by the European Medicines Agency. The members of this network (the ENCePP partners) are public institutions and contract and research organisations (CRO) involved in research in pharmacoepidemiology and pharmacovigilance. Research interests are not restricted to the safety of medicines but may include the benefits and risks of medicines, disease epidemiology and drug utilisation. Participation to ENCePP is voluntary.
ENCePP aims to strengthen the monitoring of the benefit-risk balance of medicinal products in Europe by:
Facilitating the conduct of high quality, multi-centre, independent post-authorisation studies (PAS) with a focus on observational research;
Bringing together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe and providing a platform for collaborations;
ENCePP’s main stakeholders include the research community, regulatory and public health authorities, patients and health care professional associations, and the pharmaceutical industry. The ENCePP website (http://www.encepp.eu) describes the activities of the network and provides access to its documents.
ENCePP originates from the European Medicine Agency’s endeavor to enhance scientific and operational expertise in the fields of pharmacoepidemiology and pharmacovigilance across Europe. The project started in 2006 and is a key initiative within the European Risk Management Strategy (ERMS) adopted by Heads of Medicines Agencies, which aims to apply a proactive approach to monitoring of medicines throughout their lifecycle. Instrumental to this was the establishment of a network gathering available expertise and research experience in the fields of pharmacoepidemiology and pharmacovigilance across Europe.
ENCePP focuses on public and not-for-profit organisations located in one of the EU or EFTA countries. These can be research centres, pharmacovigilance centres, university hospitals, owners of healthcare databases and/or electronic registries. Participation in ENCePP is also open to for-profit organisations such as contract research organisations (CROs), provided they perform studies commissioned by third parties and focussed on pharmacoepidemiology and pharmacovigilance research.
Existing European networks (e.g. certain rare diseases, therapeutic fields or adverse drug events) may also join ENCePP if at least one of its members is registered as an ENCePP centre.
Pharmaceutical companies cannot be an ENCePP partner, but they are encouraged to make use of the resources offered through the ENCePP networks and to participate in the public review of documents (see Q7).
Being an ENCePP partner means a commitment to
adhere to the principles of the ENCePP Code of Conduct and ENCePP Guide on Methodological Standards in Pharmacoepidemiology,
register post-authorisation studies (PAS) the ENCePP partners are conducting in the EU PAS Register,
participate in the development of research and good practice standards by contributing to, or commenting on, draft proposals prepared by working groups or the ENCePP secretariat and to
collaborate with other ENCePP partners, e.g. in multi-centres studies, and share their research experience.
ENCePP supports the conduct of pharmacovigilance or pharmacoepidemiological studies through a number of deliverables:
ENCePP partners have developed research standards in pharmacovigilance and pharmacoepidemiology through written consultation or participation in plenary and working group meetings. The following guidance is available online:
The ENCePP Code of Conduct, which provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote transparency and scientific independence throughout the research process.
The ENCePP Guide on Methodological Standards in Pharmacoepidemiology, which offers a single web resource for methodological English language guidance in pharmacoepidemiology.
The ENCePP Checklist for Study Protocols, which is a list of questions on important aspects of study design that stimulates researchers to consider important epidemiological principles when designing a pharmacoepidemiological study and that promotes transparency on study methods.
ENCePP supports the conduct of high quality industry-funded post-authorisation studies (PAS) by:
Supporting the conduct of joint studies by facilitating collaborations;
The aim of the ENCePP Code of Conduct is to provide a set of rules and principles for the conduct of pharmacoepidemiology and pharmacovigilance studies. The Code addresses critical areas in the planning, conduct and reporting of studies and provides a set of principles and recommendations to promote scientific independence and transparency of observational research and for the interaction between investigators and study funders.
The use of the Code is voluntary and highly recommended. However, it is mandatory to follow the Code for studies seeking the ENCePP Seal.
The Code of Conduct applies to the conduct of a study from its planning stage to final results. Researchers are encouraged to adhere to the principles of the Code for both ongoing and prospectively planned studies, but will be unable to apply for the ENCePP Seal retrospectively if the study has already started (see Q24).
The principles within the Code are universally applicable. There are thus no geographical restrictions as regards the use of the Code.
The principles of the Code of Conduct are applicable to all pharmacoepidemiological or pharmacovigilance studies. The Code addresses common issues encountered in industry commissioned research, in particular commercial, financial or institutional interests that could influence the outcome of a study in any particular direction. The Code also provides for research conducted with authorised medicines in the context of post-approval regulatory requirements of marketing authorisation holders.
The Code aims to complement existing legislation and associated rules and guidelines by providing a set of rules to which researchers and study funders must adhere in order to achieve scientific independence and transparency. It does not replace existing relevant legislation (e.g. Regulation (EC) 526/2014 in the case of clinical trials) or regulatory guidance published by the European Medicines Agency (EMA) such as EU Good Pharmacovigilance Practices (GVP) in which the Code is referenced e.g. in GVP Module VIII on post-authorisation safety studies (PASS).
Use of the Code is considered mandatory in certain situations, for example, if the ENCePP Seal has been applied for or if an obligation to adhere to the Code has been agreed in the research contract.
Registration of clinical trials has been a legal obligation for some time but this is not the case for non-interventional studies. The EU PAS Register as referred to in GVP Module VIII on PASS has been developed in line with ENCePP transparency principles with the aim of filling this gap. The EU PAS Register is open to all pharmacovigilance and pharmacoepidemiology studies for registration, including clinical trials, where the main focus is on safety aspects. This is regardless of whether they are initiated, managed or financed by a marketing authorisation holder, or whether they are conducted by a research centre that is a partner of the ENCePP network or any other research centre, or whether or not they qualify for the ENCePP Seal. Registration of studies is strongly encouraged and can be done at any stage (i.e. from planning to already completed). For a step by step guide how to register a study please refer to the EU PAS Register Guide.
Yes, the EU PAS Register is open for registration of all pharmacovigilance and pharmacoepidemiology studies, regardless of the country(ies) where they are conducted.
A study may be registered by anybody, typically this would be the (primary) lead investigator or someone on their behalf. In situations where no (primary) lead investigator has been nominated by the sponsor the details of the person in charge of the conduct of the study should be entered in the required fields. The individual who is entering the study details into the EU PAS Register should provide his/her contact details under the contact for scientific or public enquiries.
The EU PAS Register contains information on the study objectives, the main methodological aspects, administrative details (including study timelines and sources of funding), and associated key documents, including study protocols and study results where available.
Q18. When is registration of a study in the EU PAS Register mandatory?
Registration of non-interventional post-authorisation safety studies (PASS) conducted pursuant to an obligation imposed by a competent authority in accordance with Articles 10 or 10a of Regulation (EC) No 726/2004 or with Articles 21a or 22a of Directive 2001/83/EC is mandatory in line with the provision of GVP Module VIII on PASS. In addition, the registration of studies that wish to qualify for the ENCePP Seal is mandatory.
The ENCePP Seal is entirely free of charge and is sought on a voluntary basis by investigators who fulfil certain conditions. The ENCePP Seal places ongoing obligations on the investigators, including adherence to the entirety of the provisions of the ENCePP Code of Conduct. Certain requirements apply before the study starts whilst others relating to study results come into effect at a later stage, including after finalisation of the study. Thus, the ENCePP Seal must be applied for before the study commences (the ENCePP Code of Conduct defines the study start as “the start of data collection as defined in the study protocol”). The application and registration process is facilitated by a step-by-step guide and ready-made forms and checklists. A detailed list of the transparency requirements is provided in the Checklist of the Code of Conduct.
Studies which have been awarded the ENCePP Seal will be immediately recognisable to all stakeholders as being conducted in adherence to the ENCePP Code of Conduct, and by applying these principles of transparency and scientific independence, it will increase trust in the robustness and reliability of the findings.
No. Only studies whose lead investigator belongs to an entity that is included in the ENCePP Inventory of Centres and Networks can obtain the ENCePP Seal. Pharmaceutical companies cannot be an ENCePP partner and a study conducted solely by a pharmaceutical company cannot be awarded the ENCePP Seal. However, a study commissioned by a pharmaceutical company for conduct by an ENCePP Centre, is entitled to apply for the ENCePP Seal.
See Q&A for ENCePP partnership for further information.
To qualify for an ENCePP Seal, a study must be conducted or coordinated by a researcher from an ENCePP partner organisation and, therefore, located in one of the EU or EFTA member states. These restrictions, however, do not apply to other collaborating centres.
No, as the ENCePP Seal cannot be awarded retrospectively. An application for the ENCePP Seal (i.e. registration of the study in the database and submission of relevant documents) must be done before the study starts. However, the study can still be registered in the EU PAS Register.
Given application for the ENCePP Seal is entirely voluntary, investigators can decide they no longer wish to comply with the obligations arising from having the ENCePP Seal and ask for it to be removed. Similarly, if the ENCePP Secretariat is made aware of breaches/deviations to the rules of the Code of Conduct, the concerned study will no longer be entitled to the title ENCePP Seal Study and this information will be made public on the ENCePP website.
Arbitration and decisions concerning breaches will be made on a case-by-case basis and may be referred to the ENCePP Steering Group, whose composition is publicly available.
Yes, it is possible for the funder to become co-author(s) of publications relating to the study taking account the provisions for the Code regarding the (primary) lead investigator’s right to independently prepare publications (chapter 15) and of other requirements such as those of the International Conference of Medical Journal Editors (ICMJE) regarding author responsibilities and conflicts of interest.
As a principle, the study results should always be published, whether negative or positive, in the EU PAS Register and preferably in a peer-reviewed journal. Publication should always be timely. For ENCePP Seal studies the final study report should be provided without delay for publication in the EU PAS Register, including an abstract of the study findings in English language within 3 months following the final study report.
The pharmacovigilance legislation requires the protocols and abstracts of results of non-interventional post-authorisation safety studies (PASS) imposed as an obligation by a competent authority in accordance with Articles 10 or 10a of Regulation (EC) No 726/2004 or with Articles 21a or 22a of Directive 2001/83/EC to be published in a publicly available register (the EU PAS Register). It also specifies that the final report of such studies must provide the date of registration in the EU PAS Register. This requirement applies to marketing authorisation holders.
For ENCePP Seal studies, a copy of the study protocol needs to be uploaded in the EU PAS Register to be made public after the final study report. Publication of the protocol at an earlier stage is optional and at the discretion of the investigator. A detailed statistical analysis plan has to be included in or annexed to the study protocol.
For all other studies, the investigator decides which documents he/she wishes to make publicly available in the EU PAS Register.
The ENCePP Code of Conduct states that both the study protocol and the research contract should address rules for access to data. As a principle, data from ENCePP Seal studies should be made available as freely as possible whilst respecting European and national data protection legislation. Detailed information is available in the Implementation Guidance for Sharing of ENCePP Study Data which forms Annex 4 of the Code of Conduct.
For ENCePP Seal studies, conflicts of interest must be documented. It is mandatory to make publicly available a conflict of interest declaration in the EU PAS Register (see Annex 5 of the ENCePP Code of Conduct: form for the Declaration of Interests for ENCePP Seal studies). Similarly, the composition of the study steering group (if any) has to be made publicly available.
For all other studies, the investigator will decide which documents he/she wishes to make publicly available in the EU PAS Register.
Whilst the Code does not include an explicit reference to the use of study results for the purposes of academic teaching and academic research, the publication of final results (see Q 27) does not exclude academic teaching material and thus the study results may be used for such purposes following publication of the study results in line with the provisions of the Code.
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