CIOMS cited

Adverse drug reactions (ADRs) have a significant impact on the healthcare system worldwide. Underreporting of ADRs is identified as a main issue in pharmacovigilance. Mobile applications(apps) have been introduced as a solution for the underreporting of ADRs. This systematic review was conducted to assess the efficacy of the mobile applications in enhancing ADR reporting.

The primary objective of this scoping review is to understand and evaluate the concept, implementation, frequency, and value of "follow-up" in the context of adverse event (AE) assessment. Secondary objectives include providing an overview of various definitions of "follow-up," describing the requirements and studies evaluating follow-up methods, and assessing how often follow-up is undertaken in assessing an AE, by whom, and its value.

This review aims to define the minimal data scope for association studies in vaccine safety, providing a reference framework for implementing active vaccine surveillance systems (AVSSs) worldwide, especially in low- and middle-income countries. PubMed, Embase and Web of Science were searched for cohort and case-control studies related to AVSS published between January 1, 2018, and September 7, 2022. Guided by the WHO and CIOMS guidelines, a 4D framework for Minimum Data Sets (MDSs), including “Vaccine,” “Outcome,” “Demographic Data,” and “Covariate”, was developed.