Monitoring of informed consent is a very important activity, since consenting has a major impact on regulatory compliance across the life of a study. This article highlights some of the monitoring challenges and burdens related to informed consent for a clinical trial and explains how electronic informed consent (eConsent) can positively impact monitoring practices and documentation.
When making the switch from paper-based to electronic capture of clinical outcome assessments (COA) data there are a number of options that study teams must consider in terms of how the data is collected.
The design and implementation of an effective electronic clinical outcome assessments (eCOA) solution can be safeguarded by working through a number of defined steps throughout the course of a clinical trial. This overview demonstrates a high-level project flow for successful integration of eCOA technology from initial project scoping through to study close.
With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study life cycle, data managers will deal with data from many sources — such as MRI scans, ECGs, lab data, as well as eCOA — all of which are equally important.