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 Timing of Submission and Duration of Approval

Supplemental Methodological Studies (SMS) pertain to the Vanguard pilot phase. The SMS proposal needs to reflect that the project can be completed in a timely manner to inform the planning of the Main Study. If all required documentation is not provided in a timely manner (generally 6 to 12 months, depending upon the needs) after National Children’s Study approval, a reassessment of the proposal will be undertaken. This will be an iterative process; however, it is possible that Study approval could be rescinded if the prospects for implementing and completing the SMS in a timely manner are not acceptable.