Sponsors, Contract Research Organizations (CROs), and sites have adopted Electronic Data Capture (EDC) systems to carry out both simple and complex clinical trials in all phases of clinical research. Clinical trials are moving toward using EDC software, replacing paper records with electronic records.
Traditionally, researchers were to use paper-based forms, which in a few cases, are still done today. This paper job was cumbersome, and EDC systems have replaced this.
In a clinical trial, one needs to have accurate data, and EDC helps collect, clean, and analyze the data produced in clinical studies and now, the EDC is becoming a crucial software tool in clinical trials.
An Electronic Data Capture (EDC) sometimes is referred to as an electronic Case Report Form (eCRF) however, there is a difference. Electronic data capture, EDC, is a software that helps to collect clinical trial data. An electronic case report (eCRF) form is a digital questionnaire for collecting data about a study participant.
What is Electronic Data Capture (EDC) in clinical trials?
An Electronic Data Capture (EDC) is a web-based software application used to collect, clean, transfer, and process data in clinical trials. Simply an Electronic Data Capture (EDC) system is software that stores patient data collected in clinical trials.
Data collection for clinical trials begins on paper. It is transferred to the computer, and then is saved in an electronic Case Report Form (eCRF) Hence the Electronic Data Capture (EDC) system is also known as the electronic case report form (eCRF).
EDC systems collect different types of data depending on the therapeutic area of the clinical trial. For example, in oncology studies, the following data forms are typically used;
- Medical history
- Vital signs
- Treatment data
- Survival follow-up
- Electrocardiogram data
- Concomitant medications
- Tumor assessments
- Death information, etc.
EDC helps to record various clinical trial data, such as;
- Patient medical status and condition.
- Clinical trial safety data.
- Data from the lab reports and tests
- Patient-related information (the quality of life)
- Other patient data that is monitored by medical equipment include blood pressure, oxygen saturation, and blood sugar levels.
Data collection, cleaning, and export on the EDC system
An EDC software usually comes as a web-based application, where users who have access can log in from anywhere. This system has usernames and passwords for access. Once the user logs in to the application, they can enter the clinical data in various forms. As it is a web-based application, data entry in an EDC tool can be done remotely by local site users, who extract the patient data from the site’s source documents (medical records).
It is the process of identifying and correcting missing or inconsistent information. Data managers usually perform this job and periodically review the EDC information. They send queries to sites, asking them to clarify and correct data discrepancies if any.
After entering the data, if the data is clean, then the next step will be to export his information for further analysis. When and how to export the data will be structured in the Data Management Plan (DMP).
Regulatory and EDC
There is no legal or regulatory obligation to use EDC software in a clinical trial. However, the software should adhere to regulatory requirements when used to manage data in clinical trials.
The US FDA recommends that sponsors and researchers follow part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
Below are the list of global regulatory compliance guidelines
- The ICH-E6 Good Clinical Practice (GCP).
- EU GMP Annex 11, computerized applications in Europe.
- ERES guidelines in Japan.
- In Canada, as per the regulations as per Canadian Food and Drugs Act Division, C.02.
Advantages of using an EDC system
Using an EDC system certainly provides several advantages while conducting a clinical trial.
Let’s see a few of them.
- An EDC streamlines data collection when compared to paper-based data collection.
- The EDC system allows staff to enter data quickly and easily from any computer, making it immediately available to data reviewers.
- Efficiently manage data entry and export.
- EDC tools help to accelerate the data cleaning process.
- Data managers can review the data entered in the system and issue queries to sites to solve discrepancies.
- An EDC platform helps maintain data authenticity, integrity, and security since it integrates advanced mechanisms to manage access controls and data traceability.
Is it worth buying an EDC software for your clinical trial?
The cost of an EDC system ranges from free (open-source software) to expensive. The EDC software price varies, and vendors charge for additional services and feature integrated into the system. An EDC system can appear to be a significant financial commitment initially, but it ultimately saves money.
What are the common features of an EDC system?
Many software providers are constantly creating new features to keep up with the demands of researchers and industry changes. eCRF Designer, Data Entry, Query Management, and Data Export are some of the basic features in the EDC. Also, most EDCs have some more features listed below.
- Randomization of subject and risk management system (interactive web response system (WRS).
- Clinical Data Management System (CTMS) software helps to manage data such as study site information and IRB approvals.
- End to End-use of CDISC standards to ensure interoperability throughout the life cycle of the study.
- Risk-based monitoring to protect participants in real-time.
- Patient-reported outcomes (PRO) software.
- Standardized codes such as WHODrug and Med(DRA).
- Double data entry capability for paper and hybrid studies.
- Reporting options to generate standard and custom reports throughout the clinical trial.
- Compatibility and accessibility with all web browsers and all user languages.
Some of the advanced features in the EDC software
EDC systems provide slightly different features while maintaining the same core functions. The EDC software has undergone numerous improvements while adding new tools and features.
Some advanced functionalities include
- Automatic query mechanisms,
- Automated coding of medical terms,
- Generation of customized reports,
- Powerful modules for data cleaning and
- Source data verification.
The regulatory agencies should code adverse events against the MedDRA dictionary and code medications against the WHO Drug dictionary.
What are some of the security and data quality features EDC systems must have?
EDC systems should at least have the following mechanisms to ensure data security and traceability
- An internal clock (date and time),
- The internal clock system should consistently show the current date and time so that the system shall record all the activity taking place in the system at the right time.
- Access control module
- Access control module should be available to track each user’s access date and time, the user identity, the IP address used, and the type of access (e.g. login, logout, time out, login error).
- Activity registry.
- Activity registry must be in place to track the activity through the EDC pages. The system shall record each action in the system, such as subject ID, username, variable name, inserted value, form name, as well as the date and time of the action.
EDC integration with CTMS
- Automates daily updates from EDC to CTMS and minimizes manual data entry.
- Having complete, accurate, and near-real-time subject data in the CTMS allows these features to be utilized
- Dashboards and analytics
- Subject Payments
- Protocol Deviations
- Electronic Visit Reports (for consistency with monitoring subject data).
When choosing an EDC system for your clinical trial, you need to have a technical and good understanding of your requirements, the features necessary for your study, budget concerns, system compliance, and many others.
Credevo can help you find the best EDC system for your clinical trial and provide strategic support for clinical development.
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