What is EDC for clinical trials? Understanding electronic data capture systems

The use of electronic data capture (EDC) in clinical trials has transformed healthcare research. In 2022, 80% of clinical trial sites claimed to have used digital technologies – and for good reason. EDC offers greater flexibility, reliability, and efficiency than traditional paper-based methods. So, what exactly is EDC for clinical trials, and how does it work?

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Contents

    What is EDC for clinical trials?

    Electronic data capture (EDC) is a digital system for collecting, managing, and storing clinical trial data. Designed to streamline clinical trials, EDC helps improve data quality, minimize errors, improve accuracy, reduce costs, and simplify compliance.

    How does EDC work?

    Generally, the process of electronic data capture follows five steps:

    1. Study design and database setup
    2. Data entry and collection
    3. Data cleansing and validation
    4. Monitoring and quality control
    5. Data extraction, analysis, and reporting

    Step 1: Study design and database setup

    The first step of a clinical trial is to design your study protocol. Start by defining the objectives of the trial, identifying key variables, and deciding what data you'll collect. Think of it as laying the foundations for your trial.

    Once your study protocol is finalized, researchers can configure the EDC software accordingly. This involves creating custom data fields, validation rules, and forms to make sure data collection is consistent – and results are reliable.

    Step 2: Data entry and collection

    Now you’ve configured your database, it’s time to start collecting data from trial participants. You can log key information such as patient demographics in real time through electronic case report forms (eCRFs).

    To validate the data you’ve collected, the EDC system conducts automatic checks to catch errors as information is entered, such as missing fields or discrepancies. This helps improve data accuracy, effortlessly.

    Step 3: Data cleansing and validation

    The third step is qualifying the data. Once collection is complete, it’s automatically reviewed for inconsistencies, errors, and omissions. If something is missing, the EDC clinical trial software generates queries, and flags data entries that are incomplete or incorrect.

    This gives you a chance to review and correct the entries to make sure the data is reliable. Meanwhile, the EDC system logs each query and resolution, giving you an accurate record of data entries that were amended.

    Step 4: Monitoring and quality control

    One of the benefits of an EDC software is that data is highly accessible. Researchers, monitors, and data managers can review data quality, protocol adherence, and patient safety – remotely and in real-time.

    A built-in audit trail tracks every entry, update, and amendment, along with timestamps and user credentials. This acts as a safety net that keeps your study compliant with regulations and transparent for data traceability.

    Step 5: Data extraction, analysis, and reporting

    Finally, the EDC system is locked to prevent further changes and ensure data integrity. You can then extract the data in a variety of formats, allowing researchers to assess the efficacy and safety of the treatment.

    From here, you can generate reports to share your findings, evaluate outcomes, and submit your data for regulatory review. 

    Examples of EDC in clinical trials

    EDC systems can capture a wide range of data using electronic case report forms (eCRFs). Common examples include:

    • Demographic information: age, gender, race, ethnicity, medical history, etc.
    • Vital signs: blood pressure, heart rate, temperature, respiratory rate
    • Laboratory results: bloodwork, urinalysis, biopsies
    • Symptoms and adverse events: severity, duration, relationship to treatment
    • Medications and treatments: dosages, frequency, route of administration, start/end dates
    • Physical examination findings: weight, height, organ system assessments
    • Imaging results: X-rays, MRIs, CT scans, ultrasounds

    How EDC supports different types of clinical trials

    On-site clinical trials

    On-site trials are hosted and managed on local servers rather than cloud infrastructure. This approach provides a high level of data control and security, which is crucial if you’re handling sensitive information or operating in regions with strict data protection laws.

    Decentralized trials

    Cloud-based software allows you to access, enter, and review data from anywhere with an internet connection. This flexibility has made cloud-based systems popular, especially for decentralized trials or studies involving multiple sites. Cloud-based EDC software is also easy to scale, making it ideal for growing research teams or multi-phase studies.

    Hybrid clinical trials

    As the name suggests, hybrid trials combine on-premises and cloud-based infrastructure. A hybrid approach lets you store sensitive data securely on-site, while cloud-based EDC software allows remote data entry and real-time monitoring. This setup is perfect for meeting strict security regulations without sacrificing the agility of your trial.

     

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    EDC vs. paper-based methods: benefits and considerations

    Data entry

    EDC software allows for real time, rapid, and consistent data entry in a standardized format. On the other hand, paper-based systems require written entry, which presents the inevitable risk of misinterpretation, mistakes, and accidental omissions.

    Data retrieval

    On an EDC system, researchers can easily run queries, generate reports, access real-time insights, and make faster decisions. Whereas data retrieval from paper records is cumbersome, time-consuming, and prone to human error.

    Data security

    EDC software has advanced security, including encryption, user authentication, and access controls to protect sensitive data – ideal for compliance with HIPAA and GDPR regulations. In contrast, paper records are vulnerable to theft, loss, and damage.

    Cost efficiency

    Although EDC systems have a higher upfront cost, they lead to long-term savings by streamlining processes, reducing errors, and expediting data collection and analysis. By contrast, the costs associated with manual data entry, error correction, and inefficient data retrieval make paper-based methods less cost-effective in the long-term.

    Regulatory compliance

    EDC clinical trial software streamlines, simplifies, and improves regulatory compliance. They provide an audit trail that tracks changes, making for effortless accurate record keeping. Contrast this with labor-intensive paper-based methods, which present challenges with maintenance, resourcing, and security.

    Use cases of EDC in clinical trials

    Versatile by design, EDC software is useful in a range of clinical trial scenarios.

    Short- and long-term studies

    EDC systems streamline data collection and management, simplifying the way you track patient outcomes over time. You can also set up automated reminders for follow-up assessments, keeping data collection consistent and participants engaged.

    Multi-site trials

    EDC clinical trial software is invaluable when trials span multiple locations. For example, they allow researchers to collect data from various sites in real time – with a high degree of consistency and accuracy. This makes it easier to monitor progress, track patient safety, and analyze results rapidly.

    Patient-centric trials

    EDC systems integrate with ePRO and eCOA software, enabling clinical trial staff to access patient data effortlessly – anytime, anywhere. This includes everything from side effects to individual patient outcomes.

    Adaptive trials

    With the ability to analyze data in real-time, EDC allows researchers to quickly adjust trial parameters, dosing, or patient cohorts based on what the data reveals. This flexibility can lead to more efficient trials and faster delivery of new treatments to market.

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    The impact of EDC on clinical trials

    There are plenty of examples of how EDC software has transformed clinical trials – from study design and data collection, to quality control and reporting.

    Qmed streamlines medical device trials in large-scale study

    Qmed, a full-service CRO and consultancy streamlined their medical device trials by transitioning from paper processes to an efficient EDC software. Thanks to the flexibility of EDC, Qmed manages large-scale studies with faster data collection, reduced data entry errors, real-time monitoring, increased data accessibility, and stronger security.

    Niche Science & Technology revolutionizes psychedelic research with EDC

    With the help of Viedoc’s flexible eClinical suite, Niche Science & Technology (NST) managed complex psychedelic trials with ease. Empowered by the ability to create unique study designs, NST were able to effortlessly customize electronic case report forms (eCRFs) to fit their needs. This helped simplify the entire process and save time throughout the trials.

    LINK Medical launches leaner clinical trials EDC

    LINK Medical used Viedoc’s EDC to streamline the management of their clinical trial data across multiple regions. With a flexible suite of EDC tools, they were able to cut down on extra software, monitor study progress efficiently, and quickly adapt to trial needs.

    Transform your medical trials with proven, intuitive, and adaptable EDC software

    We believe managing clinical trial data should be smooth, simple, and efficient – no matter the complexity of your study. With the right EDC software, you can streamline data management, reduce errors, improve accuracy, and simplify compliance.

     

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    Why choose Viedoc?

    Proven

    Clinical trials depend on the accuracy, availability, and security of their data. Our eClinical suite, developed by CRO experts, ensures reliable outcomes, effortless compliance, and verifiable results. Trusted by thousands of studies worldwide, we help you achieve better results faster.

    Intuitive

    Streamline study setup and management with one centralized platform, built for simplicity and usability. Viedoc’s eClinical suite puts powerful, actionable insights at your fingertips. Complex data becomes more accessible with premium analytics and reporting tools, which provide enhanced visibility into study progress and performance.

    Adaptable

    Support clinical trials across all phases and therapeutic areas and varied levels of complexity. Our suite is instantly powerful, ensuring fast startup, smooth conduct, and streamlined closeout. Viedoc’s tools are easy to use and fully configurable to meet your trial’s specific requirements.

    Supercharge your clinical trials – request a free demo of Viedoc’s EDC

    Find out how Viedoc can make your trials more efficient, reliable, and compliant. Request your free demo today.

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    FAQs

    What are the different types of EDC?

    EDC systems can be categorized according to their deployment and data storage methods. Common types include: cloud-based EDC, on-site EDC, hybrid EDC, web-based EDC, and integrated EDC. 

    What is the best EDC system for clinical trials?

    There isn't one best EDC system. The best system for your clinical trial will depend on your requirements, budget, and the level of support needed. 

    What export formats are supported?

    Viedoc supports exports to Excel, ASCII, SAS, PDF, and CDISC ODM.

    Is Viedoc CRF 21 CFR Part 11 compliant?

    Yes, statements of compliance with various regulations, including 21 CFR Part 11 and data privacy laws, are available upon request.

    Does Viedoc store an independent contemporaneous investigator copy of the eCRF?

    Yes, all versions of a form are stored at the time the form is saved, and these remain under the investigator's control.

    Where and how frequently are backups performed?

    Backups are taken, encrypted, and replicated to the paired Microsoft Azure region every five minutes. Additionally, a full backup for each instance is encrypted and transferred to cold storage at a third location, where it is read back, restored, and tested for integrity every 24 hours.

    Can Viedoc EDC handle complex edit checks?

    Yes, edit checks can be configured to compare multiple data points across different forms and events. There is no limit to the number of data points or operations included in the validation logic. This ensures greater reliance on system validation checks and reduces the need for manual offline efforts.

    How does Viedoc address interoperability challenges for organizations using multiple software vendors?

    With rich REST API and integration capabilities, Viedoc EDC enables seamless connectivity and compatibility with any software.