The design of PASS studies depends on the objective and the type of data required. Key elements include:
- Study Population: Identifying the target population for the study. - Exposure Assessment: Determining how exposure to the product will be measured. - Outcome Measures: Defining what safety and effectiveness outcomes will be assessed. - Data Collection: Choosing the methods for gathering data, whether through electronic health records, patient surveys, or administrative databases. - Statistical Analysis: Planning the statistical methods to evaluate the data collected.
