Open access and data management for projects
This page provides an overview of the rules and guidelines related to open access to publications and research data management that apply to IMI2 projects.
Requirements for open access to publications and useful resources
Article 29.2 of the IMI2 JU Grant Agreement details the obligations related to the provision of open access to peer-reviewed publications.
In a nutshell, you must ensure open access (free, online access for any user) to all peer-reviewed publications relating to your results.
You can find further explanations in the IMI2 JU Annotated Model Grant Agreement. We have also prepared the following guide to help steer you in this process. Our guide also contains useful information on open access repositories for publications and information on where to get help in case of further questions.
Requirements to publish clinical trials results in EU Clinical Trials Database and useful resources
Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health. It assures trial subjects that their voluntary participation in clinical trials is useful and that the results have been collated and reported for the benefit of all. In addition, for those medicines which are placed on the market or used in further clinical trials, it allows patients and healthcare professionals, or any other citizen, to find out more information about medicines they might be taking or prescribing. Transparency also enhances scientific knowledge and helps to advance clinical research and support more efficient medicine development programmes.
It is the responsibility of sponsors to ensure that the protocol information and results of all clinical trials is submitted in EudraCT; this information is publicly available through the EU Clinical Trials Register (EU CTR). Since July 2014, sponsors are required to post results within one year after the end of a clinical trial (or six months for a paediatric trial). This information is also shared with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) of which EU CTR is a primary registry.
The following materials and tools are available to provide you with information and guidance on reporting trial results to EudraCT:
- Results information documentation
- Technical guideline on the format of the data fields of results-related information on clinical trials
Requirements to manage research data and useful resources
IMI supports the ‘FAIR data principles’, i.e. findable, accessible, interoperable and re-usable. This means that research data should be:
- identified in a persistent manner using community conventions, and described using sufficiently rich meta-data;
- stored in such a way that they can be accessed by humans and machines;
- structured in such a way that they can be combined with other data sets;
- licensed or have terms-of-use that spell out how they can be used by others.
You are requested to provide information on how you are planning to manage research data during the life cycle of your project through the Data Management Plan and, if your project belongs to Call 11 onwards, through your participation in the Open Access to Research Data Pilot (ORDP).
You can find more information on data management in our guide. The guide also provides useful information on research data registries and where to get help in case of further questions.
The following resources prepared by the European Commission provide further guidance on open access to scientific publications and research data.
- H2020 online manual open-access and dissemination
- Guidelines to the Rules on Open Access to Scientific Publications and Open Access to Research Data
- European IPR Helpdesk factsheet ‘Publishing vs. patenting’
- H2020 Programme Guidelines on FAIR Data Management in Horizon 2020