Data integrity and privacy
This project will produce a variety of data types across the five years of the project. All study data will be collected by trained research personnel during each study phase. Study data will be collected and analyzed from 4 primary sources, including (1) EHR data, (2) prospectively collected patient- and parent-reported data, (3) study visit data, and (4) transcripts from parent and provider interviews. Clinical data will be extracted from the EHR and/or patient charts. Throughout the trial, EHR data will be queried for utilization, pharmacy, and clinical outcome data. We do not anticipate the collection of any paper documents. Raw data will be transformed using REDCap data management tools and the subsequent processed dataset used for statistical analysis. REDCap is a secure, web-based application designed to support data entry, validation and management. Designated research staff will review REDCap data monthly to ensure data completeness and quality. To protect research participant identities and based on ethical and legal considerations, only de-identified individual data will be made available for sharing. All study data will be retained for a minimum preservation time of 3 years. The preservation time will be extended such that resulting publications have been publicly available for at least 12 months before retiring any data. Data will be made available upon request to the larger research community as soon as possible or at the time of associated publication.