An electronic data collection (EDC) system – also referred to as an electronic case reporting form (eCRF) — is a very important software tool in EDC Clinical Trials.
Clinical research relies on accurate data, and EDC solutions are used to collect, clean and analyze data obtained in clinical trials.
In this article, you will learn about the technical and practical aspects related to EDC Clinical Trials systems, including the cost of acquiring them and using them in clinical trials.
What is an electronic data collection (EDC) system in clinical trials?
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An electronic data collection (EDC) system – also known as an electronic case reporting form (eCRF) — is a web-based software application used to collect, clean, transmit, and process data in clinical trials.
Is an electronic data collection (EDC) system the same as an eCRF?
Although the concept of “EDC” has broader implications, in the context of clinical trials, the EDC system is considered the same as the eCRF.
Is it mandatory to use EDC Clinical Trials?
There is no legal or regulatory obligation to use the EDC software in a clinical trial.
Additionally, EDC systems are relatively new technologies and there was a time when clinical trials were conducted without EDCs.
For example, clinical data used to be collected using paper forms, which is still done today (although less often).
In any case, clinical data must be collected in some way, and nowadays EDC solutions are the best choice.
What are the benefits of using the EDC Clinical Trials?
The use of the EDC system certainly provides a number of advantages when conducting a clinical trial. Let’s list some of them.
First, using an EDC Clinical Trials simplifies data collection compared to paper data collection. Clinics can access the EDC system from any computer and enter data quickly and easily, making it immediately available to data controllers. This will avoid the hassle of writing and sending paper forms.
Second, EDC tools speed up the data cleaning process. Data managers can easily review data entered into the system and query pages to resolve inconsistencies.
Third, the EDC platform guarantees solid data authenticity, integrity and security as it integrates advanced mechanisms to manage access control and data traceability.
Kinds of data EDC systems collecte
EDC systems collect different types of data depending on the therapeutic area of the clinical trial.
For example, the following forms of data are typically used in oncology studies: demographics, medical history, vital signs, ECOG performance status, electrocardiogram data, biochemistry, hematology, coagulation tests, urinalysis, pregnancy tests, adverse effects, concomitant medications, tumor evaluation, data on treatment, survival tracking and death information, among others.
Data collection in the EDC Clinical Trials software?
EDC software usually comes in the form of a web application without the need to install anything on your computer.
This means that users only need to access the EDC system through a web browser using their usernames and passwords.
After logging into the application, users enter clinical data into fields contained in various data forms.
Data entry in the EDC tool is therefore performes remotely by local site users who extract patient data from site source documents (medical records).
Data cleaning in the EDC Clinical Trials system
Once hospital staff have entered clinical data into the web-based EDC platform, it’s time to refine that information by detecting and resolving inconsistencies.
The process of identifying and correcting missing or inconsistent information is data cleansing.
Data cleaning in clinical trials is typically perform by data managers belonging to the data management vendor (eg, CRO staff).
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These data controllers will periodically review the EDC information and make queries to the sites to clarify and/or correct data inconsistencies.
This process is repeated until all data is complete, clear and consistent so it can be exported and analyzed.
Data and EDC software
After the clinical data enteres into the EDC system has clean, the next step is to export this information for further analysis.
EDC applications commonly integrate data export mechanisms to generate dataset files that can in turn be use in statistical software tools (eg SAS, SPSS).
The clinical information contain in the EDC platforms is structures into datasets and the details of the export processes are documente in advance, in the early stages of the clinical evaluation.
How and how often will the data be export? in what format? These questions are usually address in a data management plan (DMP).
What are some advanced features of EDC Clinical Trials software products?
EDC software products offer increasingly sophisticated and powerful features every day.
In the clinical research sector, you can find EDC solutions with varying levels of sophistication and functionality.
Obviously, the biggest EDC Clinical Trials vendors in the industry tend to have more powerful products as they improve their solutions over the years.
EDC systems contain advanced functions to perform various tasks. Some advanced features include, for example: automatic query mechanisms, automatic coding of medical terms, customized report generation, and powerful data cleaning and source data validation modules.
An example of a very interesting advanced feature in EDC is the AutoEncoder tool from Anju Software.
When conducting clinical trials or monitoring the safety of approve products, regulatory agencies require adverse events to code according to the MedDRA dictionary and drugs to code according to the WHODrug dictionary.
Source terms are usually entere in free text and the coding process is carry out by specialist healthcare professionals who must ensure consistent and accurate decisions base on the content of the source term, any relevant associate data and previous decisions for the trial.
Anju AutoEncoder provides a modern and sophisticated tool to perform these encoding activities. It is fully integrate with Anju’s TrialMaster® electronic data capture (EDC) product out of the box, but its open interfaces allow integration with any third-party EDC or safety reporting system.
How EDC systems Work?
EDC systems require a specialized and rigorous design and implementation process for each clinical trial.
A number of plans need to write to document the design and implementation procedures, including a data management plan (DMP) and an annotate CRF document (aCRF).
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The DMP is a document that helps data managers and statistical programmers understand the type of data that will produce in a clinical trial and how that data will be collect, store, clean, exported, and analyze.
The aCRF is a document that maps the clinical data collection fields used to capture patient data to the corresponding variables contained in the Study Data Model (SDTM) datasets.
The EDC system design and implementation process essentially consists of developing system specifications and then actually building the software system itself (implementation, testing and validation of data forms and fields) according to these requirements.
These activities are perform by the data managers of the company entrust with building the EDC system (e.g. CRO staff).
What regulatory requirements should EDC solutions meet?
The regulatory requirements that EDC systems must meet have establish in the United States through Part 11 of Title 21 of the Code of Federal Regulations; electronic records; Electronic Signatures (21 CFR Part 11).
In order to achieve compliance of EDC systems with regulations, the following technical controls must be in place:
- Technical controls: Measures that ensure the quality, accuracy and integrity of data stored in electronic systems.
- User Authorization Checks: Security measures to identify the person accessing the application and sending data to prevent unauthorized access to the system.
- Audit trail controls: Measures to ensure that the system keeps records of where the data came from, who made the changes, when and what information change.
- Attribution controls: Measures to ensure that data can obtain in such a way that all information relating to each subject in the study can attribute to that subject.
- Data Validation Checks: Checks perform by computer systems to ensure the validity and quality of clinical information.
Finally, system integrity measures must implement to guarantee system integrity and protect against data loss (eg regular backups).
What are some of the main security and data quality features that EDC systems must have?
EDC systems should have at least the following mechanisms to ensure data security and traceability: internal clock (date and time), access control module and activity register.
The internal clock system should consistently show the current date and time so that all activity occurring in the system is record with the correct time.
Second, there should be an access control module that will track each user’s access date and time, user identity, IP address used, and type of access (eg login, logout, timeout, login error).
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Additionally, an activity registry must be in place to track activity through the EDC site. For each action in the system, data such as subject ID, username, variable name, insert value, form name, as well as the date and time of the action should record.
What are the best EDC systems?
Some of the best and most widely used EDC systems are Medidata’s Rave, Oracle’s Inform, and Anju Software’s TrialMaster.
How big is the market for EDC Clinical Trials systems in the United States?
According to this Electronic Data Capture Systems market size, share and trends analysis report:
“The global electronic data capture systems market size was value at USD 349.8 million in 2016. The growing complexity of managing clinical information generate before, during and after a trial is expect to drive the demand for EDC systems over the forecast period. Statistics published by the Center for the Study of Drug Development indicate that more than 80% of clinical trials fail because they are unable to meet regulatory requirements, resulting in delayed commercialization of drugs. This led to a loss of income for producers. EDC systems help reduce this problem by simply capturing and managing clinical information.”
US EDC Clinical Trials Systems Market, by Component, 2014-2025 (USD Million)
How much does EDC software cost?
Prices for EDC software tools may vary depending on the quality level and number of advanced features of each system.
The reader is encourage to read the article “How Much Does an Electronic Case Report Form (eCRF) Cost? learn about the costs of the EDC system.
Visit our wbsite at Vial to know more about EDC Clinical Trials.
