Conceptual Model and Requirements of An Electronic Case Report Form to Collect a Minimum Data Set of Complications of the COVID-19 Vaccine

Abstract

Introduction: In recent years, the collection of data from the monitoring of clinical trials in the form of electronic case report forms (eCRF) has been increasingly used, because avoiding mistakes, reducing the duration of clinical studies, and preventing increasing data collection costs can affect the success of the study. Accordingly, this research aimed to present the conceptual model and requirements of the proposed eCRF, which is based on NoSQL database to achieve complications caused by the COVID-19 vaccine. Method: In this study, using the descriptive-applicative method, the conceptual model of the eCRF system was first designed to collect the minimum set of data on the complications of the COVID-19 vaccine. Then, the functional and non-functional requirements of the proposed system were identified using the methods of observation, thinking and reflection, and questionnaire. Results: This research has two main parts: the proposed conceptual model and the functional and non-functional requirements of the eCRF system. A conceptual model was proposed based on the components, modules, and objectives of the eCRF core, which can be used by researchers and clinical trial specialists. Requirements including the ability to register, insert, delete, and edit the case report form, were also calculated for four groups of patients, health care workers, disease experts, and the executive manager. Conclusion: The proposed system provides researchers and experts of clinical trials with classified and valid data regarding the registration of complications caused by the COVID-19 vaccine in an integrated manner. Therefore, some eCRF stakeholders such as patients, healthcare workers, disease experts, and executive managers and researchers can achieve a vaccine with acceptable safety and effectiveness by analyzing, interpreting, and sharing the recorded information.

Keywords

• electronic case report form
• covid-19
• vaccination adverse effects
• ecrf system requirements