Sponsors, contract research organizations (CROs), and sites have adopted electronic data collection (EDC) systems to conduct both simple and complex clinical trials at all stages of research. Clinical trials are moving towards the use of EDC Clinical Trials software, which replaces paper records with electronic ones.
An electronic data collection clinical trials (EDC) system, also referred to as an electronic case reporting form (eCRF), is becoming a key software tool in clinical trials. In a clinical trial, you need to have accurate data. EDC helps collect, clean and analyze data obtained in clinical trials.
Traditionally, researchers had to use paper forms, which are still used today in a few cases. This paper work was cumbersome and EDC Clinical Trials systems have replaced it.
What is electronic data collection EDC Clinical Trials?
Electronic Data Collection (EDC) is a web-based software application used to collect, clean, transfer and process data in clinical trials also an electronic data collection (EDC) system is software that stores patient data collected in clinical trials.
In clinical trials, data is first captured on paper and then transferred to the system and stored in an electronic case report form (eCRF). Therefore, the EDC Clinical Trials system is also known as the Electronic Case Report Form (eCRF).
EDC Clinical Trials systems collect different types of data depending on the therapeutic area of the clinical trial. For example, the following data forms are typically used in oncology studies: demographics, medical history, vital signs, treatment data, survival monitoring, electrocardiogram data, concomitant medications, tumor assessment, death information, etc.
EDC helps to record various clinical trial data such as
- Patient health status, status data, etc.
- Safety data from clinical trials.
- Lab reports, tests and other similar data.
- Patient related information such as quality of life.
- Patient information from monitoring health facilities (blood pressure, oxygen saturation, blood glucose level, etc.).
- Collection, cleaning and export of data in the EDC Clinical Trials system
EDC software is typically delivered as a web-based application that users with access can log in from anywhere. This system has usernames and passwords for access. Once the user logs into the application, they need to enter clinical data into various data forms. Since it is a web-based application, data entry in the EDC tool can be performed remotely by local site users who extract patient data from the site’s source documents (medical records).
The process of identifying and correcting missing or inconsistent information is known as data cleansing. Data managers typically do this work and regularly review EDC information and send queries to the site, asking them to clarify and/or correct data inconsistencies.
After entering the data, if the data is clean, the next step will be to export its information for further analysis. When and how to export data will be structured in a data management plan (DMP).
Regulatory and EDC Clinical Trials
There is no legal or regulatory obligation to use the EDC software in a clinical trial. However, when using data management software tools in clinical trials, the software must comply with regulatory guidelines.
The US FDA recommends that sponsors and researchers follow Code of Federal Regulations Part 11 of Title 21; electronic records; Electronic Signatures (21 CFR Part 11).
Other regulatory bodies and their compliance guidelines
- ICH-E6 Good Clinical Practice (GCP).
- EU GMP Annex 11, Computer Applications in Europe.
- ERES guidelines in Japan.
In Canada, in accordance with the regulations of the Canadian Food and Drugs Act Division, C.02.
Advantages of using the EDC Clinical Trials system
The use of the EDC system certainly provides a number of advantages when conducting a clinical trial.
Let’s look at a few of them.
- EDC simplifies data collection compared to paper data collection.
- Employees can access the EDC system from any computer and enter data quickly and easily, making it immediately available to data controllers.
- Easily manage data entry and export.
- EDC tools help speed up the data cleaning process.
- Data managers can easily review data entered into the system and query pages to resolve inconsistencies.
- The EDC platform helps maintain the authenticity, integrity and security of data by integrating advanced mechanisms to manage access control and data traceability.
Is EDC software worth buying for your clinical trial?
The cost of an EDC system ranges from free (open source software) to expensive. The price of EDC software varies also vendors charge for additional services and features integrated into the system. At first, buying an EDC system may seem like a big investment, but it saves money in the long run.
What are the common features of the EDC system?
Most software vendors are constantly developing new features to keep up with changes in the industry and the needs of researchers but eCRF Designer, Data Entry, Query Management and Data Export are some basic functions in EDC. Most EDCs also have some additional features as listed below.
- Randomization of subject and risk management system (interactive web response system (WRS).
- Clinical Data Management System (CTMS) software for managing data such as study site information and IRB approval.
- End to end use of CDISC standards to ensure interoperability throughout the study lifecycle
- Risk-based monitoring to protect participants in real time.
- Patient Reported Outcomes (PRO) software.
- Standardized codes such as WHODrug and Med(DRA).
- Dual data entry option for paper and hybrid studies.
- Reporting options to generate standard and custom reports during the clinical trial.
- Compatibility and accessibility with all web browsers and all user languages.
- Some advanced features of EDC software
Most EDC systems offer slightly different features, while the basic functionality remains the same. There are many advancements in EDC software, tools and features are being expanded as needed.
Some advanced features include
- Automatic query mechanisms,
- Automatic coding of medical terms,
- Generating customized reports,
- Powerful data cleaning modules and
- Validation of source data.
- Regulatory agencies require MedDRA coding for side effects and WHO drug coding for drugs.
What are some of the main security and data quality features that EDC Clinical Trials systems must have?
EDC systems should have at least the following mechanisms to ensure data security and traceability internal clock (date and time), the internal clock system should consistently show the current date and time so that the system records all activity occurring in the system at the correct time.
Access control module
An access control module should be available to track each user’s access date and time, also user identity, IP address used, and type of access (eg login, logout, timeout, login error).
In order to track activity through the EDC site, an activity registry must be in place. The system records every action in the system, such as the subject ID, username, variable name, inserted value, form name, as well as the date and time of the action.
Integrating EDC with CTMS
It automates daily updates from EDC to CTMS and minimizes manual data entry.
Complete, accurate, and near-real-time subject data in CTMS enables the use of these features
- Dashboards and analytics
- Subject of payment
- Protocol deviations
Electronic visit reports (for consistency with data on the monitored subject).
When choosing an EDC Clinical Trials system for your clinical trial, you need to have a technical and solid understanding of your requirements, the features necessary for your trial, and the budget issues. system compliance and many.
Vial can help you find the best EDC system for your clinical trial and provide strategic support for clinical development.