Master Alliance Provisions Guide (MAPGuide)

CEPI – Valneva, Chikungunya Vaccine Funding Agreement

  • Information & materials sharing | Data management

7. Clinical Studies

7.2 Clinical Data. The data arising in the conduct of a clinical trial will be collected in a way that ensures that each subject, prior to enrolment and in accordance with all applicable laws and regulations, including the EU’s General Data Protection Regulation (GDPR), provides informed consent to allow:

a. direct access to her or his medical records;

b. the processing of data relating to her or him and to the movement of that data to other countries, including countries outside of the European Economic Area;

c. the transfer of such data to Awardee;

d. the transfer of anonymised data to CEPI in accordance with Clause 11 [Dissemination & Publication of Project Data];

e. the collection and use of clinical study data (duly anonymised and, at CEPI’s request, blinded) in accordance with and for the purposes indicated in Clause 11;

f. the collection and use of biological samples and the use of data (duly anonymised and, at CEPI’s request, blinded) derived from such samples by CEPI or its designated Assessors in accordance with and for the purposes indicated in Clause 12 [Dissemination of Project Materials]; and

g. the use of such data for the purpose of obtaining approval from applicable regulatory agencies.