Provision Language
Definitions
“Project Data” means pre-clinical or clinical trial data generated by or on behalf of a Partner under any Work Package, including any such data with respect to negative results, model animal deaths and any toxicology study results. For clarity, Project Data shall not include any Chemistry, Manufacturing and Controls (“CMC”) or other manufacturing- related information or data.
“Project Materials” means biological samples or, if applicable, animal models that are controlled by a Partner and are generated by or on behalf of Partner under any Work Package.
“Project Results” means the Project Materials, Project Data and Technical Reports that are generated by or on behalf of a Partner and/or any Subawardee under the Project, including with respect to results of assays necessary for Project Clinical Trial Material manufacturing in support of such manufacturing by or on behalf of a Partner and/or any Subawardee under the Project, whether in whole or in components or serum samples collected. For clarity,Project Results does not include Project Clinical Trial Materials.
10. DISSEMINATION OF PROJECT RESULTS; PUBLICATION
10.1 Dissemination of Project Data. CEPI encourages the timely publication and other dissemination of Project Results. The Partners shall make the Project Data available to specified third parties if and to the extent described in a Work Package, as agreed by the JMAG, or as otherwise may be agreed between the Parties, always in compliance with applicable data protection legislation.
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10.3 Publication of Project Data for the Outbreak Research Community. Each Partner shall promptly publish or cause to be published Project Data consisting of reasonably relevant and appropriate pre-clinical and clinical trial data (for clarity, excluding raw data) in a peer- reviewed scientific journal to inform the public health response and help save lives. Key principles of this sharing of data have been agreed to by funders, research organisations, government agencies, civil society organisations and for-profit life science enterprises, as described and provided in (i) WHO’s 2016 Guidance for Managing Ethical Issues in Infectious Disease Outbreaks; and (ii) WHO’s 2016 Guidance on Good Participatory Practices in Trials of Interventions Against Emerging Pathogens.
10.4 Clinical Trial Registration and Results.
10.4.1 Project Clinical Trials and any other clinical trials that utilise any Project Clinical Trial Materials must be registered through an easily discoverable existing public route such as clinicaltrials.gov, The EU Clinical Trials Register, or the International Clinical Trials Registry Platform, in accordance with all applicable laws and regulations. The information provided shall follow the current WHO Trial Registration Data Set. The clinical trial ID or registry identifier code/number shall be included in all publications of clinical trials.
10.4.2 Publication of clinical trial results (including negative results) from Project Clinical Trials and any other clinical trials that utilise any Project Clinical Trial Materials shall be made by the Partner who has been responsible for the applicable Project Clinical Trial Materials or other clinical trial promptly through an easily discoverable existing public route (website or system). Such Partner shall submit clinical trial data from Project Clinical Trials and any other clinical trials that utilise any Project Clinical Trial Materials for publication as soon as reasonably possible but, in any event, within [***] after study completion. During the same time period, such Partner shall make the results available to the national Ministry of Health or equivalent in the countries where Project Clinical Trials are held. Such Partner shall deposit Clinical Trial data in an open sharing platform such as ClinicalStudyDataRequest.com, Vivli Center for Global Clinical Research Data, or an equivalent service.
10.5 Open Access. Prior to publishing any manuscripts of any research publications, journal articles, scholarly monologues and book chapters with respect to any Project Clinical Trial published under this Clause 10, the applicable Partner shall submit a copy to CEPI. Each Partner must ensure that a copy of the final manuscript of all research publications, journal articles, scholarly monologues and book chapters with respect to any Project Clinical Trial published under this Clause 10 is deposited into PubMed Central (or Europe PubMed Central) or otherwise made freely available upon acceptance for publication or promptly after the publisher’s official date of final publication. Moreover, each Partner shall ensure that all peer-reviewed published research that is funded, in whole or in part, by CEPI shall be published in accordance with the principles of Plan S (“Accelerating the transition to full and immediate Open Access to scientific publications”), a UK and European data sharing initiative for research funded by public grants. Each Partner shall comply with CEPI’s reasonable requests to share information in a preprint service such as bioRxiv.
10.6 Statement of Support in Publications. All such publications with respect to any Project Clinical Trial shall include a statement that the work was “supported, in whole or in part, by funding from CEPI” (or such other words to the same effect regarding other sources of (direct or indirect) funding for the Project as reasonably requested by CEPI, as applicable) and shall credit, where appropriate, the country in which any such clinical trials were performed.