Master Alliance Provisions Guide (MAPGuide)

EDCTP2 Policy on Clinical Trials Registration, Publication and Data Sharing

  • Open sciences & open data | Open data

§5.2 Open Research Data

Open Access is the default setting for research data generated in EDCTP2 and H2020. For more information see the H2020 Guidelines on Open Access. The legal requirements for projects participating in the Open Research Data pilot are set out in Article 29.3 of the EDCTP2 Grant Agreement. However, not all data can be open. Beneficiaries must ensure data privacy and that personal data are not shared. Projects may opt out of the open research data pilot at any stage (either before or after signing the grant) and so free themselves retroactively from the obligations associated with the conditions if:

  • Participation is incompatible with rules on protecting personal data
  • Participation is incompatible with the obligation to protect results that can reasonably be expected to be commercially or industrially exploited
  • Participation is incompatible with the need for confidentiality in connection with security issues
  • Participation would mean that the project’s main aim might not be achieved
  • The project will not generate / collect any research data or
  • There are other legitimate reasons

EDCTP expects all projects conducting clinical studies to have a data management plan that is updated during the course of the project. A data management plan is a mandatory deliverable for EDCTP2 projects (RIAs). EDCTP is in the process of developing a data management portal in support of open access to clinical data from EDCTP2-funded clinical trials and studies.

 

5.3 Research Actions Targeting Public Health Emergencies

For actions targeting public health emergencies, the beneficiaries must deposit the digital research data generated in the action in a research data repository and take measures to make it possible for third parties to access, mine, exploit, reproduce and disseminate the data free of charge for any user, at the latest within 30 days after it has been generated.

 

Open access to research data” refers to the right to access and reuse digital research data under the terms and conditions set out in the Grant Agreement.

Research data” refers to information, in particular facts or numbers, collected to be examined and considered as a basis for reasoning, discussion, or calculation.