The National Children’s Study Research Partnerships Program Director leads the formal process of review and approval of Supplemental Methodological Studies (SMS). Review of SMS applications will be conducted by Program Office scientists and, as needed, additional subject matter experts.
The review will assure the quality of integrity of the proposed SMS and assess: 1) its support of Vanguard Study goals (feasibility, acceptability, and cost of methodological aspects of the Study) and of current needs to inform the Main Study; and 2) its impact on the Vanguard Study infrastructure and participants.
Specific areas of review include but are not limited to: scientific value; relevance and “fit” with the Vanguard Study; burden to participants and to the Study infrastructure; appropriate use of the limited biospecimens and environmental samples; etc.
The initial review may result in a “Deferred Decision” pending response to specific questions or revisions as indicated by reviewer feedback. Alternatively, an application may be given “Provisional Approval” pending receipt and approval of additional required documentation. Applications that are not approved may, in some circumstances, be offered opportunity to revise and resubmit.