Iterative Process of Developing Policies and Procedures to Guide a Phase III RCT

Background: Policies and procedures were required for data safety and quality monitoring purposes in preparation for launching a multi-site, Phase III, randomized-control trial designed to compare the efficacy and impact of two asthma health-education interventions delivered to fifth-grade students diagnosed with asthma enrolled in 30 schools located in two communities. Purpose: To describe the iterative process of drafting, reviewing, approving, and implementing policies and procedures for data safety and quality monitoring purposes. Significance: Launching successful studies requires that clear policies and procedures are drafted prior to study implementation; however there is a dearth of information about how researchers develop these valuable tools. Methods: Using the grant proposal and institutional review board applications as a guide, over 90 policies and procedures were drafted to ensure quality control and compliance with federal and university guidelines, as well as the school districts' and asthma coalitions' requirements. A spreadsheet was used to organize and code the policies and procedures under the following categories: personnel, participant, and community partner components, data safety and monitoring, and intervention delivery. Additionally, fidelity, and dosage forms were developed for monitoring each data collection and intervention delivery session. The structure of the forms was standardized. Findings: Advanced development of policies and procedures helped the administrative core anticipate and avoid potential missteps during implementation. Conclusions: Developing policies and procedures prior to implementation is beneficial. Findings indicate that advanced development using a structured format provides a solid foundation for modifying and adapting policies and procedures within existing studies and between future studies.