The purpose of a clinical investigation (or clinical study) is to determine the safety and effectiveness of a novel treatment, such as a medical device. Biostatisticians make determinations about the results of a clinical investigation by analyzing data from Case Report Forms (CRFs) completed by investigators for each patient during the investigation.
In the past, CRFs from a clinical study would be completed on paper, packed into boxes, and shipped from the study location to a secondary location for analysis. But today, a growing number of medical device companies are going paperless and using web-based Electronic Data Capture (EDC) Systems to collect, store, and manage clinical data.
Software-based EDC systems give clinical study managers the ability to streamline the data collection process, capture more accurate data, and enhance data security and accessibility - all while saving time and reducing the cost of completing a clinical study.
In this blog, we’re breaking down everything you need to know about EDC Systems and the transition from paper-based to digital CRF recordkeeping for medical device clinical studies.
An Electronic Data Capture (EDC) system is a software solution that makes it easier for medical device companies to digitally collect, store, and manage the patient data collected during clinical investigations. Nowadays many EDC systems are distributed in the Software-as-a-Service (SaaS) business model and accessed by sites and sponsors over the Internet.
EDC systems allow the sponsor of a clinical study to create customized electronic CRF (eCRF) forms that can be completed by the researchers performing the study. EDC systems can be configured and programmed by data managers to validate user inputs, ensuring that any data collected is both accurate and complete. After sufficient data has been collected, EDC software allows clinical study managers to export the data to external tools for analysis.
The terms EDC and eCRF come up often when we’re discussing digital data management for medical device clinical trials, so it’s important to define each one and understand how they’re different.
An Electronic Data Capture (EDC) System is a software application that helps streamline the process of collecting, storing, and securing data from clinical studies, while an electronic Case Report Form (eCRF) is the digital version of a Case Report Form (CRF) used by researchers to record data from about patients participating in a clinical trial.
Stated differently, the term “eCRF” refers to the digital forms that researchers will complete when using EDC software for a clinical trial, while the term “EDC” refers to the software itself.
EDC software systems are purpose-built to collect and organize data from clinical trials/studies, including eCRF documents and readings from medical devices and other instruments.
An eCRF can include information such as:
The purpose of a clinical study is to gather data regarding variables that are relevant to the research hypothesis. For medical device companies, the purpose of a clinical study is to evaluate the safety and efficacy of a medical device for treating a specified disease or condition in patients.
Because each clinical study is different, data collection practices vary significantly between clinical studies. EDC systems allow clinical trial sponsors to design customized eCRF forms to ensure that researchers collect the necessary data as per the stated research hypothesis and data collection plan.
For clinical studies following a paper-based data collection strategy, there’s only one real option for data collection: researchers complete paper CRFs, store them, then box and ship them to clinical trial sponsors where biostatisticians will analyze the results.
To better understand how EDC fits into the clinical study workflow, let’s look at three methods researchers use to input data into an EDC software:
The first option for EDC data collection is direct data entry. Researchers can login to the EDC software using secure access credentials, open the relevant eCRF for the study, and enter clinical data into the system where it immediately becomes available for data reviewers and other stakeholders.
Researchers can also choose to complete CRF forms the traditional way, using paper, then transcribe those paper CRFs into the EDC system at a later time.
Having said that, we do not recommend simply copying the paper-based CRF to an electronic CRF inside an EDC system for a number of reasons. The most important being, previous challenges encountered on paper, will be transferred to the electronic format.
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Transcription-based data collection may also take place when data from patient-reported outcomes (PRO) or electronic health records (EHR) is entered into the EDC.
An important advantage of using EDC instead of paper-based data collection is the ability to capture data via automatic transmission. Modern EDC systems can receive data transmissions from ePRO instruments (which are sometimes a part of the EDC), and connected medical devices (DHT)s, automating those portions of the data collection process.
The most efficient medical device companies in 2022 are using EDC software to collect, store, and secure the data they collect in clinical investigations. Below, we summarize six major advantages of EDC software and why it makes sense to move away from paper-based data collection.
Using a software-based EDC system for clinical activities helps streamline the data collection process throughout the medical device lifecycle.
With traditional paper-based data collection, physical CRFs must be completed by researchers, shipped to the study sponsor, and transferred by data entry teams into a computer database before analysis can occur. Using an EDC for clinical data collection bypasses this lengthy process by empowering researchers to create the data in a digital format with an eCRF.
EDC systems also streamline data collection by enabling the automatic transmission of clinical data from PRO instruments and medical devices.
Improved data quality is another advantage of deploying an EDC for data collection in clinical trials.
By streamlining the data collection process, clinical study managers cut down on the possibility for errors in data entry and transcription that occur at higher rates in the convoluted paper-based data collection process.
EDC systems can also incorporate software-based mechanisms for improving data quality, including edit checks, numerical data validation, and remote monitoring, to ensure that data inputs are accurate and correctly formatted before they reach the trial database.
These EDC features give researchers the opportunity to correct data entry mistakes and discrepancies before they can influence the outcome of the study.
Collecting clinical trial data in an EDC system is a great way to ensure the security, authenticity, and reliability of the data.
While paper-based CRFs can easily be lost, stolen, or damaged - either on-site or in transit, the eCRFs created in a software EDC system are immediately uploaded to secure cloud storage where there’s zero risk of data loss. EDC systems can also incorporate security features, such as role-based access controls (RBAC), multi-factor authentication, and more, to ensure that only authorized persons may access the data.
Another advantage of recording clinical data in an EDC system is that the data is more accessible. Once an eCRF has been completed by researchers and saved in your EDC system, it can be accessed immediately from anywhere in the world with an Internet connection by anyone with the appropriate authorization.
Instead of waiting for a box of paper CRF forms to arrive by mail, data reviewers can start reviewing and analyzing eCRF data just moments after it has been created. With near real-time access to data, it becomes easier for clinical trial managers to detect trends and make well-informed decisions.
When it comes to analyzing clinical data from paper-based CRF forms, the most time-consuming tasks include transcribing, cleaning, preparing, and transforming the data, and defining the database structure prior to analysis.
Entering data directly into an EDC system with eCRFs standardizes the data entry process and reduces the need to invest massive time and effort in data transcription and preparation after data has already been collected. As a result, clinical data collected in EDC can be analyzed much sooner after it is collected by researchers.
Collecting data with an EDC system reduces the overall cost of conducting clinical trials. By streamlining the data collection process, leveraging automation to ensure high-quality data, and reducing the need for data cleaning and preparation, EDC systems reduce the total cost of data collection and analysis needed to complete a study.
The ability to execute clinical studies more quickly means that medical device companies can fast-track their pathway to market authorization and start realizing profits even sooner than expected.
SMART-TRIAL EDC is the first and only data gathering and management system that’s purpose-built for medical devices and diagnostics.
With SMART-TRIAL, medical device companies can create customized eCRF forms and digitize data collection for clinical investigations, in-human studies, and post-market surveillance activities.
SMART-TRIAL is out-of-the-box compliant with ISO 14155:2020 and includes templates for data collection planning and regulatory compliance that help medical device companies execute organized, cost-effective, and compliant studies that bring products to market faster.
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