7. Clinical Studies
[Some Projects may involve clinical studies, and this Clause 7 describes relevant compliance obligations in addition to the conditions given under Clause 6. Some of the “consent” requirements described here are necessary for enabling some of the data and sample access procedures described in Clauses 11 and 12.]
7.4 The Awardee will: […]
c. publish details of any clinical study in a publicly accessible clinical study register, where patient privacy is upheld, as required under law and, as applicable, prior to the commencement of patient recruitment for such clinical study;
11. Dissemination and Publication of Project Data
[This Clause 11 describes how Project Data, including clinical study data, should be disseminated. CEPI’s Scientific Integrity Policy and Clinical Trials Policy are pertinent.]
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.
11.3 Publication of Project Data. CEPI encourages the timely publication of Project Data and other Project Results in scientific literature.
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.