“Safety Issues” means any material concerns regarding safety or efficacy of any Product studied under the Project, including serious adverse events or serious adverse reaction, safety–related signals, product recalls or relevant recommendations from the Data Safety Monitoring Board to place a hold on or to end a clinical study.
6. Compliance with Applicable Laws and CEPI Policies and Procedures
[This Clause 6 describes various compliance obligations applicable to Awardee, including “CEPI Policies and Procedures” and other policies that flow down from CEPI’s own funders. Compliance with CEPI’s Clinical Studies and Animal Studies policies are also addressed in Clauses 7 and 8 respectively, and CEPI’s Open Access policy is addressed in Clause 11.6.]
6.3 The Awardee will: […]
d. to the extent that the Project involves relevant activities, comply with Good Laboratory Practices (“GLP”), Good Clinical Practices (“GCP”) and Good Manufacturing Practices (“GMP”) as defined either in the CEPI Policies and Procedures or otherwise under applicable law or best practice;
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.]
7.1 Clinical Studies. If any Work Package includes research involving human subjects, such activities must comply with applicable laws, relevant regulatory agencies and CEPI’s Clinical Trials Policy.
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;
e. the collection and use of clinical study data (duly anonymised and, at CEPI’s request, blinded) 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 for the purposes indicated in Clause 12; and
g. the use of such data for the purpose of obtaining approval from applicable regulatory agencies.
7.3 Priority for Clinical Studies. Awardee acknowledges that the pool of subjects available in areas of Outbreak to participate in a clinical study to test products such as the Product may be limited. Accordingly, if CEPI determines that a product other than the Awardee’s Product has substantially greater potential and should be used for a particular clinical study, the Awardee agrees that it shall abide by such decision and will not proceed with a clinical study of the Product unless agreed with CEPI.
7.4 The Awardee will:
a. be the sponsor of any clinical study (unless CEPI and Awardee otherwise agree in writing);
b. be responsible for obtaining and maintaining all regulatory approvals (including ethical committee approvals) necessary or reasonably useful for the conduct of the clinical trial and appropriate clinical trial insurance cover;
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;
e. establish a Trial Steering Committee (TSC) and Data Safety Monitoring Board (DSMB);
f. notify the JMAG and TSC in writing immediately following any Safety Issues or similar events;
g. verify that the clinical study data are complete and include all completed case report forms and all other clinical study documentation required to be in the possession of a clinical trial sponsor by applicable law; and
h. permit a CEPI representative or nominee (except for any matters that should remain blinded to CEPI in the interests of the integrity of the clinical study) to:
i. attend meetings of the TSC and the DSMB for the clinical study as an observer (either in person or by electronic means); and
ii. receive all papers that a member of the TSC or DSMB would be entitled to receive.