Key Takeaways:
- Electronic case report form (eCRF) software is a digital version of a paper case report form. With the help of software, researchers gather data from patients such as demographics, treatments, and patient medical history.
- Establish the study’s needs, including the kind of data to be gathered, the number of study visits, the study population, and the data analysis strategy, before creating an electronic case report format.
- Create an eCRF by using an EDC system. This entails establishing edit checks, validation rules, and data entry screens.
Effective data management is critical in the ever-changing clinical research and healthcare fields.
Clinical trial data collection, organization, and analysis using traditional methods are frequently laborious, error-prone, and time-consuming. However, the introduction of Electronic Case Report Form (eCRF) software has completely changed how clinical data is managed, providing researchers and medical practitioners with an all-inclusive and efficient solution.
A study states that automated transfer of data from EHR (Electronic Health Records) to eCRF has the potential to reduce data abstraction and entry burden as well as improve safety and data quality.
To make the best out of eCRF software, let’s understand its benefits, components, and design process in detail.
eCRF vs. EDC: What’s the Difference?
Electronic case report form (eCRF) software is a digital version of a paper case report form. With the help of software, researchers gather data from patients such as demographics, treatments, and patient medical history. This data is securely stored on the cloud and shared with stakeholders in real-time.
Whereas, an EDC (Electronic Data Capture) system for a clinical trial or study is a software program that facilitates the digital collection, storage, and management of patient data collected by medical device companies. Many clinical EDCs are available in the SaaS business model and are accessible to sites and sponsors via the Internet.
A clinical EDC system enables the sponsor to create custom electronic case report (eCRF) forms that can be filled out by the researchers conducting the study. Data managers can configure and program clinical electronic data capture systems to verify user inputs and ensure that all data collected is correct and complete. Once enough data is collected, clinical study managers can export the data into external tools for data analysis.
Components of Electronic Case Report Form (eCRF) Software
Here is a list of components that are included while designing eCRF software. These are basic must-have components, however software developers can add more components and features as per user requirements.
- Data Validation: Forms include values that may fall outside the range or at times violate criteria set by the designer. The criteria are known as ‘edit checks’. If a user enters a value that violates an edit check then the system alerts the user with a message. Additionally, failed edit checks give rise to automatic queries. These are reviewed by the data manager and they confirm the accuracy of value.
- Choice Label: Here, a choice is offered to the user among multiple options, such as ‘yes’, ‘no’, or ‘maybe’. The user selects the desired option which is saved to the database.
- Form Label: A form label describes the type of questions asked in a form. It helps clinical researchers differentiate one form from another.
- Group Label: So, a form may include multiple questions, and groups help to categorize them. Note that a group can recur in a form, for example, blood pressure which is measured multiple times in a day.
- Item Label: A precise, clear, and short prompt for a user to enter the specific data. The label maybe a term or a single word, for instance bad cholesterol level.
- Field: This is a blank box where users fill the information.
- Value: This is the data entered into the field. It can be a choice or single value from the dropdown list.
How to Design Electronic Case Report Form (eCRF) Software
One of the common mistakes found in eCRF software is collecting too much data. A great eCRF design ensures that only essential data is collected in short time period. For better data collection process, clinical researchers and sponsors can plan out data gathering activities and clinical investigation in advance. Here’s how to kickstart eCRF design process:
1. Set Clear Hypothesis
A clinical study’s primary goal is to collect information on factors that are pertinent to your research hypothesis. Establish the study’s needs, including the kind of data to be gathered, the number of study visits, the study population, and the data analysis strategy, before creating an electronic case report format (eCRF).
This stage aids in determining the eCRF’s required data fields and the data’s logical flow. The research requirements, which include data types, validation criteria, and edit checks, must be taken into consideration while determining data fields. Text, numeric, date/time, and dropdown lists are examples of data fields.
2. Have a Data Collection Strategy
Make sure your clinical trial data is correct and pertinent by developing a plan for data collection that specifies the questions to be asked and how the answers should be presented on an electronic clinical file (eCRF).
Here’s type of data that can be included eCRF:
- Data from medical devices that includes heart rate, blood glucose levels, oxygen saturation, etc.
- Lab reports
- Treatment
- Patient health history, vital signs, and current medical status
- Clinical study site
- Demographic data and patient characteristics
3. Design the Electronic Case Report Form
You can create an eCRF by using an EDC system. This entails establishing edit checks, validation rules, and data entry screens. After identifying the data fields, decide how the eCRF should be laid out.
This covers a range of data visualization techniques, including data field organization, tabbing and scrolling, and the application of color coding and other visual aids.
4. Test and Validate
To make sure it functions as intended, the eCRF needs to be tested. This entails testing the validation rules, edit checks, and data entry interfaces.
Verify the eCRF’s compliance with regulations by validating it. This entails recording the outcomes of the system’s testing against specified acceptance criteria.
5. Deploy and Observe
You can deploy the eCRF to research sites after it has been validated. This include making the eCRF accessible, instructing study participants on how to use it, and making sure the data is gathered, processed, and sent in a secure manner.
Keep an eye on the eCRF to make sure it’s being used properly. This entails updating the eCRF, answering inquiries, and carrying out routine data assessments.
In conclusion, by leveraging the capabilities of electronic case report form (eCRF) software, researchers can streamline data collection, enhance data quality, and accelerate the pace of clinical research, ultimately leading to improved patient outcomes and advancements in medical science.
If you’re looking for eCRF software development, then connect with Arkenea, a leading healthcare software development company in the USA. Hop on to a consultation call with us to know more.