What Is EDC Clinical Trials And eCRF
The purpose of a clinical trial (or clinical trial) is to determine the safety and effectiveness of a new treatment, such as a medical device. Biostatisticians determine clinical trial outcomes by analyzing data from Case Report Forms (CRFs) completed by investigators for each patient during the trial.
In the past, clinical trial CRFs were completed on paper, boxed, and shipped from the trial site to a secondary site for analysis. But today, a growing number of medical device companies are moving away from paper and using web-based electronic data capture (EDC Clinical Trials) systems to collect, store and manage clinical data.
EDC Clinical Trials software systems empower clinical trial managers to streamline the data collection process, capture more accurate data, and improve data security and availability-all while saving time and reducing the cost of clinical trial completion.
In this blog, we discuss everything you need to know about EDC Clinical Trials systems and the transition from paper records to digital CRFs for medical device clinical trials.
What is an Electronic Data Capture (EDC Clinical Trials) system?
An electronic data collection (EDC) system is a software solution that makes it easy for medical device companies to digitally collect, store and manage patient data collected during clinical trials. Currently, many EDC systems are distributed in a Software-as-a-Service (SaaS) business model and accessed by sites and sponsors over the Internet.
EDC systems allow the sponsor of a clinical trial to create customized electronic CRF forms (eCRFs) that can be completed by the investigators conducting the trial. EDC systems can be configured and programmed by data controllers to validate user input and ensure that all data collected is accurate and complete. Once sufficient data has been collected, the EDC software allows clinical trial managers to export the data to external tools for analysis.
EDC Clinical Trials vs. eCRF – what’s the difference?
The terms EDC Clinical Trials and eCRF come up a lot when discussing digital data management for medical device clinical trials, so it’s important to define each and understand how they differ.
An electronic data collection (EDC) system is a software application that helps streamline the process of collecting, storing and securing clinical trial data, while an electronic case report form (eCRF) is a digital version of the case report form (CRF). used by researchers to record data about patients participating in a clinical trial.
In other words, the term “eCRF” refers to the digital forms that researchers fill out when using the EDC software for a clinical trial, while the term “EDC” refers to the software itself.
What kind of data can you collect in the EDC system?
EDC software systems are designed to collect and organize data from clinical trials/trials, including eCRF documents and data from healthcare facilities and other tools.
The eCRF may contain information such as:
- Patient characteristics and demographics,
- Site of the clinical study and treatment group of the patient,
- The patient’s medical condition, medical history and measurement of vital functions,
- Treatment effects/uses
- Patient lab reports and test results,
- Data from medical devices connected to the patient (e.g. blood pressure, heart rate, oxygen saturation, blood glucose level, etc.)
The purpose of a clinical trial is to collect data on variables that are relevant to a research hypothesis. For medical device companies, the purpose of a clinical trial is to evaluate the safety and effectiveness of a medical device for treating a specific disease or condition in patients.
Because every clinical trial is different, data collection procedures vary significantly between clinical trials. EDC Clinical Trials systems allow clinical trial sponsors to design customized eCRF forms to ensure that researchers collect the necessary data according to the stated research hypothesis and data collection plan.
How is data collected in the EDC software?
For clinical trials following a paper-based data collection strategy, there is only one real data collection option: researchers complete paper CRFs, store them, then package them and send them to clinical trial sponsors, where biostatisticians analyze the results.
To better understand how EDC fits into a clinical trial workflow, let’s look at three methods researchers use to enter data into EDC software:
1. Direct data entry
The first option for EDC data collection is direct data entry. Researchers can log into the EDC Clinical Trials software using secure access credentials, open the appropriate eCRF for the study, and enter clinical data into the system where it is immediately available to data reviewers and other stakeholders.
2. Transcript from paper or electronic sources
Researchers may also choose to complete CRF forms in the traditional manner using paper and then transcribe those paper CRFs into the EDC system at a later date.
For a number of reasons, we do not recommend simply copying a paper CRF to an electronic CRF in the EDC system. Most importantly, the previous challenges we encountere on paper will convert into electronic form.
View or read the free e-book “7 Principles of eCRF Design” to learn best practices for eCRF design to reduce costs and save time.
Transcription-based data collection may also occur when data from patient-reported outcomes (PROs) or electronic health records (EHRs) are entered into the EDC.
3. Automatic transmission
An important advantage of using EDC instead of paper data collection is the ability to capture data through automatic transmission. Modern EDC systems can receive data transmissions from ePRO devices (which are sometimes part of the EDC) and connected medical devices (DHTs), automating these parts of the data collection process.
What are the most important features of the EDC Clinical Trials system?
- eCFR Builder
- Electronically Reported Patient Outcomes (ePRO)
- Adverse event reporting modules
- Drug Modules
- eConsent
- Integration of connected devices and wearables
- Integration options through application programming interfaces (APIs)
- Case-based data collection
- Survey data collection
- Integration with the Clinical Trial Management System (CTMS)
6 Advantages of using EDC software in clinical examinations/medical device studies
The most effective medical device companies in 2022 use EDC software to collect, store and secure the data they collect in clinical trials. Below, we summarize the top six benefits of EDC software and why it makes sense to ditch paper-based data collection.
1. Streamline the data collection process
Using a software-based EDC system for clinical activities helps to streamline the data collection process throughout the life cycle of a healthcare facility.
In traditional paper data collection, physical CRFs must complete by researchers, send to study sponsors, and transfer by data entry teams to a computerize database before analysis can occur. Using EDC for clinical data collection bypasses this tedious process by allowing researchers to create data in a digital format using eCRF.
EDC systems also streamline data collection by enabling automatic transfer of clinical data from PRO tools and medical devices.
2. Improving data quality
Improved data quality is another benefit of deploying EDC for data collection in clinical trials.
By streamlining the data collection process, clinical trial managers have reduced the potential for data entry and transcription errors that occur to a greater extent in the convoluted paper-based data collection process.
EDC systems may also include software mechanisms to improve data quality, including edit control, numerical data validation, and remote monitoring to ensure that data inputs are accurate and properly formatted before they enter the test database.
These EDC features give researchers the opportunity to correct data entry errors and inconsistencies before they can affect the outcome of a study.
3. Improve data authenticity and security
Collecting clinical trial data in the EDC Clinical Trials system is a great way to ensure the safety, authenticity and reliability of the data.
While paper CRFs can easily disappear, stolen or damaged – either on site or in transit, eCRFs create in the EDC software system are instantly upload to secure cloud storage where there is zero risk of data loss. EDC systems can also include security features such as role-based access control (RBAC), multi-factor authentication, and more to ensure that only authorized individuals have access to data.
4. Make clinical data available
Another advantage of recording clinical data in an EDC system is that the data is more accessible. Once researchers complete an eCRF and save it to your EDC system, it can be access instantly 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 in the mail, data reviewers can begin reviewing and analyzing eCRF data as soon as it is creat. Access to data in near real time makes it easier for clinical trial managers to spot trends and make informed decisions.
5. Accelerate the completion of clinical trials
When it comes to analyzing clinical data from paper 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 the EDC Clinical Trials system using eCRF standardizes the data entry process and reduces the need to invest enormous time and effort in transcribing and preparing data after the data already collect. As a result, clinical data collect in EDC can analyze much sooner after it is collect by researchers.
6. Reduce the cost of clinical operations
EDC data collection reduces the overall cost of conducting clinical trials. By streamlining the data collection process, using automation to ensure high-quality data, and reducing the need for data cleaning and preparation, EDC Clinical Trials systems reduce the overall cost of data collection and analysis required to complete a study.
The ability to conduct clinical trials faster means that medical device companies can fast-track their path to registration and start realizing profits even earlier than expected.
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