Can the parent trial be a non-US trial? Does the parent trial have to be funded by the NIH?
The parent trial does not have to be funded by NIH. The parent trial can be funded by industry, a health organization(s), other governmental agencies, or any other non-NIH funding sources. However, applicants are required to provide a copy of the parent trial protocol so that the reviewers can consider whether it will provide an adequate and proper source of data, tissue or patients for their ancillary study.