Conducting clinical trials has become a complex and time-consuming affair. Stakeholders, investigators, and pharmaceutical companies are working along with researchers and medical professionals, aiming for effective recruiting, practical achievements, and quick trial turnarounds.
Experts and global authorities have realized that the key to achieving any given study objective is establishing a reliable and secure data management plan. Electronic case report forms have become a major factor of good source documentation practices.
Each clinical trial involves numerous procedures, constant monitoring, and thousands of participants. To be more precise, a clinical trial will normally involve the generation of multi-site heterogeneous data with complex input formats and forms (Mathura, 2007). Data may vary from personal information, group assignments, adverse-event logs, questionnaires to lab results.
Therefore, having reliable, readable, transparent, accessible, and safe data is crucial for each study. What’s more, all data collection procedures should be done in accordance with global ethical regulations and standard practices.
Although in research ‘one model can’t fit them all,’ usually, data collection methods can be divided into pen-and-paper and electronic formats. Traditionally, data collection can be done by summarizing medical reports, lab results, and charts on paper case report forms (pCRFs). However, this method shows to be time-consuming, tiring, and prone to errors. Readability issues may arise, which in addition may become an obstacle for audits. What’s more, when it comes to data collection and documentation, training of personnel is needed, which is a significant financial burden on the research budget. In fact, studies show that staffing reaches almost half of the study budget; to be more precise – 40-45% of research allocations (“A paradigm shift in patient recruitment for clinical trials,” 2017).
Since the 1980s, researchers have started to implement electronic case report forms (eCRFs) in clinical trials and research. As mentioned above, eCRFs have become a leading aspect of good source documentation practices as they are linked to easier monitoring and data collection, improved data quality and completeness, and audit facilitation and safety. With the inclusion of technical features, such as alarms, automatic completions, and reminders, eCRFs permit speedier database processing and shorter study periods. Moreover, studies show that the use of eCRFs results in reduced losses, errors, costs, and transport logistics. Last but not the least, eCRFs are especially beneficial for multi-center trials (Le Jeannic, 2014). Establishing connections between research is crucial for practice and patients’ well-being.
All the advantages eCRFs have over pCRFs have led to a crucial shift in research preferences. A survey among investigators, clinical research associates (CRAs), and data managers (DMs) reveals a positive attitude towards electronic forms. Note that younger and tech-savvy individuals show even higher preferences for eCRFs.
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.
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:
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