Supplemental Methodological Studies (SMS) pertain to focused studies that take place during the Vanguard (pilot) phase of the National Children’s Study. They are geared to inform the Main Study as to the feasibility, acceptability, and/or cost of items pertaining to recruitment, operational and logistic issues, and Study visit assessments. Supplemental Methodological Studies are initiated from outside of the Program Office and are developed outside the Study protocol planning process. They are funded externally; that is, not with the National Children’s Study appropriation. The Principal Investigator will be identified by the applicant. Each SMS will have a Study Co-Investigator. SMS that will be conducted at more than one location will also have a Study Facilitator for each additional location (see Responsibilities section).
Supplemental Methodological Studies are integrated with the Vanguard phase. That is, they involve National Children’s Study participants and/or laboratory samples. Requests for just data are not SMS. In contrast, substudies are a type of formative research involving participants and/or laboratory samples, but initiated and funded by the National Children’s Study.
Supplemental Methodological Studies will generally be short-term efforts to support the Vanguard pilot goals. For these studies to inform the design of the Main Study, a prompt turn-around time is pertinent.
Please send general inquiries to NCSSuppMethStudies@mail.nih.gov