Understanding the process of Data Entry and Data Processing in Clinical Trials
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An Electronic Data Capture (EDC) system, also known as an electronic Case Report Form (eCRF), is quickly becoming a necessary software tool in clinical trial database management. Accurate data is required in a clinical experiment. Therefore, clinical study data is collected, cleaned, and analyzed with the aid of EDC.
Researchers used to fill out paper forms, which are still used in a few circumstances today. However, this was a time-consuming paper process, and EDC technologies have now taken their place.
In clinical trials, what exactly is Electronic Data Capture (EDC)?
An Electronic Data Capture (EDC) is a web-based software tool used to gather, clean, transport, and process data in clinical trials known as an Electronic Data Capture (EDC).
Data is collected on paper initially, then transmitted to the system, and kept in an electronic Case Report Form in clinical studies (eCRF). As a result, the electronic case report form is another name for the Electronic Data Capture (EDC) technology (eCRF).
Depending on the therapeutic area of the clinical programming services, EDC systems capture several sorts of data. For example, the following data formats are commonly used in cancer studies: demographics, medical history, vital signs, treatment data, survival follow-up, ECG data, concomitant drugs, tumor evaluations, death information, etc.
EDC assists with the recording of a variety of clinical trial database management data, including
- The medical information on the patient, such as their condition, is also available.
- Safety statistics from clinical trials
- Test results, lab reports, and other similar information are all available.
- Information on a patient’s quality of life, for example.
- Patient data from medical devices track them (blood pressure, oxygen saturation, blood glucose levels, etc.).
What are the characteristics to look for in an EDC?
- A user-friendly interface that is tailored to the demands of medical researchers.
- A user-controlled platform that enables cooperation between numerous sites and scholars worldwide.
- To prevent human mistakes, the ability to define data limitations for all acquired data
- Ensured compliance with privacy and data protection rules and compliance with statutory requirements and the collection and storage of research data.
- Integration with current tools, wearables, legacy systems, and other technology that works seamlessly
- For the primary study team, the statistical analysis team, and any future data consumers, the capacity to reuse research data is critical.
- You’ll have access to clinical programming services to proactive assistance and technical advisers to assist you in setting up your clinical studies.
What kind of data do EDC systems collect?
Depending on the therapeutic area of the clinical trial, EDC systems capture several sorts of data.
For example, demographics, medical history, vital signs, ECOG performance status, electrocardiogram data, biochemistry, hematology, coagulation tests, urinalysis, pregnancy tests, adverse events, concomitant medications, tumor assessments, treatment data, survival follow-up, and death information are all commonly used data forms in oncology studies.
What advantages does an EDC system provide?
Many research institutions recognize the benefits of EDC over other techniques and are using new technology to help them assist clinical trials. These are some of the ways that an EDC system may help you succeed:
- Access to data in a shorter amount of time With real-time access to data and less time spent on query management, an EDC system may save a substantial amount of time. This hoards time at the end of the research by making the data more readily available for analysis. While learning how to operate a system can take a long time, some are so simple to use that only a few hours of training are necessary.
- Data protection is very important. A web-based interface is used to enter data into an EDC system. Software suppliers ensure that the data gathered in an EDC system is safeguarded and backed up, given the nature of the data. Because each user account has its permissions, most actions are restricted to certain roles.
- Data quality is improved using EDC systems. For example, constraints can be added to a form to prevent erroneous or unreasonable values from being input. In addition, legible inputs and automated computations are possible with a computerized system, resulting in cleaner data.
- Organization. Due to its user-friendly navigation, implementing an EDC system improves clinical trial efficiency. Search options simplify discovering and filtering precisely what you need, allowing you to keep everything in one place for better visibility and less paper usage.
- Cost-Effectiveness. An EDC system might cost anything between zero and thousands of rupees. Pricing varies, and some suppliers charge extra for services and other charges. Investing in an EDC system may appear costly at first, but it will save you money in the long term.
- Compliance. An EDC must follow regulatory regulations. To maintain data integrity, the program should be equipped with technological controls. Standard operating procedures (SOPs) are necessary to ensure that regulatory and organizational regulations are followed when maintaining an EDC system.
Contract research organizations (CROs), university researchers, medical devices, biotech, and pharmaceutical corporations have embraced electronic data gathering methods. However, researchers who fall behind in using this technology may find it more difficult to stay up due to globalization and developments in global collaboration in medicine.
Element Technologies provides a user-friendly and compliant solution for clinical programming services for academic researchers and pharmaceutical businesses. They don’t need any prior technical experience. Element Technologies’ world-class support team is also there for you when you need it.