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This page provides answers to the most frequently asked questions about ENCePP and its key principles.
If the answer to your question is not here, please email us at encepp_secretariat@ema.europa.eu
Q1. What is the purpose of ENCePP?
ENCePP originates from the European Medicine Agency’s endeavour 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), which aims to apply a proactive approach to monitoring of medicines throughout their lifecycle. ENCePP provides an opportunity to improve pharmacoepidemiological research, post-authorisation safety surveillance and risk-benefit monitoring of medicines by increasing research capacity based on the principles of transparency and scientific independence. Instrumental to this is the establishment of a network of excellence gathering available expertise and research experience in the fields of pharmacoepidemiology and pharmacovigilance across Europe. Participation in ENCePP and all related activities is done on a voluntary basis.
ENCePP focuses on public and not-for-profit organisations located in one of the EEA/EFTA countries. These can be research centres, university hospitals, owners of healthcare databases and/or electronic registries and existing European networks covering certain rare diseases, therapeutic fields and adverse drug events of interest.
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.
In order to join the ENCePP network, researchers need to be located in one of the EEA/EFTA member states. There are no pre-established qualifications required, although at the time of an application to register, centres are requested to provide a list of recent publications to confirm their research focus.No, although ENCePP provides a valuable resource that pharmaceutical companies can make use of. This can be done either by contacting directly the individual centres and networks that are registered in the Research Resources Database or by submitting a request to the ENCePP Secretariat to place a Third Party announcement in the ENCePP Partners' Forum that is accessible to ENCePP partners only.
The objectives of the ENCePP Code of Conduct are 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 the interaction between investigators and study funders.
The use of the Code is voluntary. However, it is mandatory to declare adherence to the Code for studies seeking the ENCePP Study seal by submitting a completed and signed Checklist and Declaration on compliance as part of an application for the seal. ENCePP Studies are, therefore, studies that have confirmed their intention to comply with the provisions of the Code in their entirety.The Code of Conduct applies to the conduct of a study from its planning stage to final results. Researchers are free to adhere to the principles of the Code or make use of the Code at any stage of their study, but will be unable to apply for the ENCePP Study seal if the study has already started.
There are no geographical restrictions as regards the use of the Code.
The Code of Conduct has been drawn up to address common issues encountered in commissioned research. However, the principles that inspired the development of the Code are applicable to any kind of pharmacoepidemiological and pharmacovigilance studies, including self-funded.
The Code aims at complementing existing legislation and associated rules and guidelines by applying the principles of transparency and independence and streamlining the interaction between researchers and study funders. It does not replace existing relevant legislation (e.g. Directive 2001/20/EC in the case of clinical trials). The use of the Code is only considered mandatory if a study is to be awarded the ENCePP study seal or if an obligation to adhere to the Code has been agreed in the research contract.
In line with the principle of trust there is no established monitoring scheme, although investigators of ENCePP Studies are obliged to inform the ENCePP Secretariat without delay if a study deviates from and/or no longer follows the rules of the Code. The ENCePP Steering Group will also investigate on a case-by-case basis if there are any signs (e.g. claims by third parties) that an ENCePP study does not fully comply with theprovisions of the Code.
Registration of clinical trials has been a legal obligation for some time but this is not the case for non-interventional studies. The ENCePP electronic Register of Studies (E-Register) has been developed in line with ENCePP’s transparency principles with the aim of filling this gap. The E-Register is open to all pharmacovigilance and pharmacoepidemiology studies for registration, including clinical trials, regardless of the nature of the sponsor or whether or not they qualify for the status of ENCePP Studies. Registration of studies is strongly encouraged and can be done at any stage (i.e. from planning to already completed). A step-by-step guide for registering a study in the E-Register is available here.
Yes, the E-Register is open for registration of all pharmacovigilance and pharmacoepidemiology studies, regardless of the country(ies) where they are conducted.
The E-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.
Registration of studies in the E-Register is mandatory only for studies that wish to qualify for the ENCePP Study seal.
The ‘ENCePP study’ seal is entirely free of charge and is sought on a voluntary basis by investigators who fulfil the CoRe requirements. The ENCePP study 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 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 carrying the ‘ENCePP Study’ seal will be immediately recognisable to the general public as being conducted in adherence to the ENCePP study principles, and through transparency and clarity of roles, it will increase trust in the robustness and reliability of the findings. Awarding of the seal cannot, however, be interpreted as a guarantee on the scientific quality of a study.
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 study seal. Pharmaceutical companies cannot be an ENCePP partner and a study conducted solely by a pharmaceutical company cannot be awarded the ENCePP study seal. The study, however, can still be registered in the E-Register.
A study commissioned by a pharmaceutical company for conduct by an ENCePP centre, however, is entitled to apply for the ENCePP study seal. See Q&A for ENCePP partnership for further information.To qualify for an ENCePP study seal, a study must be conducted or coordinated by a researcher belonging to an entity included in the ENCePP Inventory of Centres and Networks and, therefore, located in one of the EEA/EFTA member states. Other collaborating centres, however, may be located outside the EEA/EFTA countries.
No, as the seal cannot be awarded retrospectively. An application for the ENCePP study 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 E-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 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 of other requirements such as those of the International Conference of Medical Journal Editors (ICMJE).
As a principle, the study results should always be published, whether negative or positive, in the ENCePP E-Register and preferably in a peer-reviewed journal. Publication should always be timely. For ENCePP studies, the full final study report should be provided without delay for publication in the E-Register, while an abstract of the study findings is required within 3 months of the final study report. The lead investigator may ask to delay the publication of this abstract for a limited period pending response to peer review comments.
For ENCePP Studies, a copy of the study protocol needs to be uploaded in the E-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 non-ENCePP Studies, the investigator decides which documents he/she wishes to make publicly available in the E-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 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 Studies, conflicts of interest must be documented. It is mandatory to make publicly available a conflict of interest declaration in the E-Register (see Annex 5 of the ENCePP Code of Conduct: form for the Declaration of Interests for ENCePP studies). Similarly, the composition of the study steering group (if any) has to be made publicly available.
For non-ENCePP studies, the investigator will decide which documents he/she wishes to make publicly available in the E-Register.
