An Electronic Data Capture (EDC) system is software that’s used to electronically collect, manage and store clinical research trial data. This data gets collected, uploaded and saved in an electronic Case Report Form (eCRF). EDCs can either replace or back up traditional paper-based methods of data collection, streamlining processes and improving long-term data accuracy, efficiency and security.
This type of system is especially useful for clinical trials with a higher number of patient data points like In Vitro Diagnostics (IVD). When you’re working with large data sets or complex planning scenarios, EDC systems make it easier to design the most effective solutions through more effective data management.
How Do EDCs Support Data Management?
EDC systems support data management by offering a customizable, streamlined way to capture relevant patient data points. The information that gets collected and uploaded will depend on the user’s unique needs. Most systems offer flexibility in the types of data points you’re able to collect. Commonly collected information includes:
- Demographic data about clinical trial participants
- Comprehensive medical histories including past conditions, previous treatments, surgeries, medications and allergies
- Clinical assessment data like lab results, vital signs and the outcomes of physical examinations
- Adverse Events (AE) and safety data that documents patient reactions or side effects during the trial
- Patient-reported outcomes like quality of life assessments, pain scales and similar subjective insights
Access to the sensitive clinical trial data that’s collected can be limited to only authorized individuals using most EDC systems. Authorized personnel may include researchers, clinicians, data managers or study coordinators. Remote viewing of EDC data for authorized users is a feature that can make centralized data management possible for multi-site studies.
Figuring out what you need to make your study — and its data — as safe and efficient as possible is something NAMSA’s clinical research consultants can help with.
The Benefits of an EDC System
Electronic data capture (EDC) systems streamline clinical trial data collection and management. More validation checks ensure accurate data while real-time data access enables faster decision-making. More specifically, they promote success by offering:
- Accuracy. EDC systems contribute to improved data quality through built-in management features that promote accuracy. Constraints can be set on data entry forms to prevent the input of inaccurate or illogical values. Integrated error detection systems eliminate issues related to illegible entries and enable automatic calculations, leading to cleaner, more reliable data.
- Compliance. Robust data security measures ensure the confidentiality of sensitive patient information. These systems also facilitate implementation of validation checks and constraints in alignment with regulatory requirements. The audit trail functionality of most systems enables comprehensive tracking of data modifications and user activities, aiding in regulatory compliance and simplifying audit processes.
- Safety. Being able to review each adverse event (AE) to determine whether it meets criteria for endpoint adjudication makes it far easier to bring a product to market. Making sure that data is collected, stored and managed efficiently simplifies the entire process.
Do I need to use an EDC during clinical trials?
No you don’t need to, but you may be missing out on innumerable benefits.
If your data isn’t perfectly clean when you submit your clinical trial data, you’ll be asked to redo it. The amount of money and time wasted can add up fast — and it’s all easily avoided with the right trial tech and support. Knowing what your endpoints and evaluation goals are when you set up your trial are imperative to ensuring success when it’s submitted.
Don’t risk your product development success by letting your data get messy. Talk to NAMSA’s team today to see how our years of experience managing, cleaning and supporting clinical trial data can benefit your product on its way to market.
Marcella Martin, MBA, RAC is a Senior Regulatory Consultant at NAMSA with over ten years’ experience working in regulatory affairs in the medical device and pharmaceutical industries. She has authored and managed a variety of submissions to FDA, Health Canada and notified bodies. These have included pre-submission, IDE, IND, technical file, master file, device license application, ANDA, Annual Report and vigilance reporting. She has completed regulatory assessments and regulatory strategies for products in development and for proposed changes to products already on the market. Marcella holds a Masters of Business Administration (MBA) degree from Colorado State University, Fort Collins and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).