11.1 Reporting of Project Data. Awardee shall provide CEPI with access to all data and information, including all clinical study data, produced or arising as a result of the Project (“Project Data”), and will report Project Data regularly to the JMAG.
11.2 Sharing of Project Data with the Research Community. Awardee will share Project Data as described in the IPDP relevant to topics of interest to the research community, such as disease-specific assays, animal models, correlates of protection or diagnostics and epidemic preparedness mechanisms, subject to reasonable protection for Awardee’s rights under this Agreement.
11.4 Clinical Study Data. CEPI’s Clinical Trials Policy requires that clinical data and results (including negative results) must be disclosed publicly in as close to real time as possible. Accordingly, such data must be shared through an easily discoverable public route (website or system) that includes a metadata description, where patient privacy is upheld, and the system follows a request-for-information approach (where requests are fulfilled subject to an independent review and approval step). Clinical study data will be submitted for publication within twelve (12) months after each final study report or report submitted to CEPI. The Clinical Trial ID or registry identifier code/number shall be included in all publications of clinical trials.
11.5 Outbreak-Related Publications. Additionally, Project Data will be shared in accordance with WHO’s 2016 Guidance for Managing Ethical Issues in Infectious Disease Outbreaks and WHO’s 2016 Guidance on Good Participatory Practices in Trials of Interventions Against Emerging Pathogens.
11.6 Open Access. CEPI requires “Open Access” for Project Data. This means that a copy of the final manuscript of all research publications, journal articles, scholarly monologues and book chapters published under this Clause 11 must be deposited into PubMed Central (or Europe PubMed Central) or otherwise made freely available upon acceptance for publication or immediately after the publisher’s official date of final publication. Moreover, 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.
11.7 The Awardee will: (a) notify the JMAG on an ongoing basis as Project Data is produced and disseminated; (b) disseminate Project Data consistent with the requirements set out above; and (c) cooperate in regard to data analysis, to the extent relevant under a given Work Package, by CEPI’s Assessors by: (i) providing data or other information generated under this Agreement to CEPI’s designated Assessor as CEPI shall request, including data regarding CMC, formulation or the results of any of its pre-clinical or clinical trials (duly anonymized and, upon CEPI’s request, blinded); (ii) providing CEPI’s designated Assessor with other data (duly anonymised and, upon CEPI’s request, blinded) as CEPI may reasonably request in order to conduct comparative assessments; and (iii) providing CEPI’s designated Assessor with clinical study data (duly de-identified and, at CEPI’s request, blinded) for the purposes of signal detection or meta-analyses of safety data (including across candidate vaccines).