As mentioned above, paper forms are slowly being replaced by digital formats. For instance, Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS) are widely used in research (Schweitzer, 2016), with a focus on medical data registries. Usually, eCRFs facilitate data collection and are highly beneficial in pragmatic trials, without interfering with drug administration and constant monitoring.
In a nutshell, eCRFs are electronic case report forms used to collect detailed data and facilitate coordination between investigators and sponsors; eCRFs can help researchers answer study objectives or test hypotheses. Depending on the size of the study, data collection can be a flexible process: data can be captured over a period of weeks, months, or years. In fact, it may also include data from check-up visits, even months after patients’ treatment has ceased.
Note that traditionally, the research institution conducting the clinical study is responsible for the specific design of any eCRF. Specific eCRFs help researchers achieve an integrated solution for the needs of their research body (of any size). Nevertheless, perhaps the most beneficial aspect of eCRFs (relevant to our global society), is the fact that eCRFs enable the remote sharing of clinical data and multi-center analysis, allowing productive audits. At the same time, research standards and confidentiality are the main objectives of any eCRF design, and in fact, software solutions like Qolty guarantee 100% safety.
Goals and Benefits of eCRFs
Data Capture: eCRFs allow detailed data collection at distinct times (Meinecke, 2017). Having data in real-time guarantees accurate observations and reliable findings.
Data Management & Flexibility: eCRFs facilitate the rapid capturing of vital clinical data, including transfer from and to external devices. Better results often lead to practical improvements, effective drug development, and high levels of patient satisfaction.
Work-flow Process: As eCRFs implement automated alerting processes, medical staff and patients benefit from research. Automated features eliminate the need for additional training and at the same time, they boast people’s motivation. Pop-up windows can be helpful attributes.
Data Integration: eCRFs enable the standardized storage of data, which is focused on both research and clinical care, and eliminate interference with treatment. In other words, electronic forms benefit research theory and medical practice.
Transparency & Interoperability: eCRFs give access to transparent data at all times. At the same time, eCRFs support the sharing of data with all the different stakeholders involved in each study. These semantic and syntactic interoperability features are especially beneficial in multi-center trials and international research.
Standards: eCRFs follow standards (described below) to provide interoperability for data exchange, which may facilitate research. The Standards are created in accordance with ethical principles and safety procedures.
Thus, the levels of satisfaction regarding eCRFs data collection (among investigators, CRAs, and DMs), are high: