As medical practitioners and researchers learn about the benefits of electronic data capture systems (EDC), their preference for EDC technologies increases. Most clinical studies now use EDC, but some still stick to paper-based clinical data capture and management – generally in smaller phase I studies.
Paper to EDC isn’t just about replacing the EDC system with current Case Report Forms (CRF). People use web content in a different way than they do paper. CRFs must offer functionality with a computer screen, keyboard, and mouse when put online. Researchers must think about the benefits and limitations of paper forms and the EDC technologies in clinical research.
The switch from paper to EDCs requires several changes discussed below:
1. Transition from Paper to Electronic Data Capture Systems for Clinical Research
Web-based EDC adds interactivity to paper CRFs (pCRFs). In EDC, electronic case report forms (eCRFs) allow people to interact with a responsive system that performs actions right away.
2. Database Management
Clinical research data must be present in a database, whether paper-based or sourced from EDC technologies. This database has a set of rules for how it stores data. For each question on your eCRFs, you will have to set response values and types.
This is how medical practitioners and researchers can use EDC in clinical trials. When planning to put your pCRFs into an electronic form, you’ll need to think about which type of input to use for each question.
3. Key Criteria
Moving from paper to EDC requires several changes. You need to know your EDC system inside and out, understand your data specifications, and apply desired workflows and validation rules to succeed with EDC.
These parts work together to make a comprehensive EDC study, giving better results than paper studies. EDC system users will have to build a resource library for future studies. This will make running future studies in the system easier.
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