ELECTRONIC DATA CAPTURE SYSTEM

 

What is an Electronic Data Capture System

• Electronic Data Capture System is software, which involves medical device companies to digitally collect, store, and manage the patient data collected during clinical investigations. Currently, EDC systems are available in the Software-as-a-Service business model.
• EDC allows a sponsor to create a Customized eCRF.

What are the advantages of the EDC system in clinical trials?

 

1.    Using an EDC system for data collection when compared to paper-based data collection. With EDC it is possible to enter data quickly and easily and make it available to data reviewers

2.    EDC tools accelerate the data cleaning process. Data managers can easily review the data entered into the system and issue queries to sites and solve them.

3.    An EDC platform confirms solid data authenticity, integrity, and security since it integrates advanced mechanisms to manage access controls and data traceability.

What kind of data is collected in EDC?

 Purpose of EDC - collect and organize data from clinical trials, including eCRF documents and readings from medical devices.

An eCRF can include information such as:

·       Patient characteristics and demographic data

·       Clinical study site and patient’s treatment group

·       Patient health status, history, and vital sign measurements

·       Treatment effects/use

·       Patient lab reports and test results

·       Readings from patient-attached medical devices

How is data collected in EDC software?

 

1. Direct Data Entry

 Researchers can login to the EDC software using secure access credentials, open the relevant eCRF for the study and enter the data in to the system and make it available for reviewers.

2. Transcription from Paper or Electronic Sources

 It is not possible to simply copy the paper-based CRF to an electronic CRF but it is possible to encounter the previous challenges on paper to the electronic format.

3. Automatic Transmission

EDC systems can receive data transmissions from ePRO instruments and connected medical devices (DHT)s, automating those portions of the data collection process.

•    EDC systems designs and implementations

EDC systems are specially designed and implemented for each clinical trial.

To document the design and implementation, the following documents are required

•  A DMP is a document that helps data managers and statistical programmers to understand the data from a clinical trial i.e; the type of data how it is produced, and how it will be collected, stored, cleaned, exported, and analyzed.
• An aCRF is a document that maps the clinical data collection fields used to capture patient data and contained within the Study Data Tabulation Model (SDTM) datasets.

 What regulatory requirements should EDC solutions meet?

 To achieve regulatory compliance (United States through the 21 CFR Part 11) of EDC systems, the following technical controls must be in place:

• Technical controls: Measures that ensure the quality, accuracy, and integrity of data stored in the electronic systems. 
• User authorization controls: Security meaures to prevent unauthorized access to the system. 
• Audit trail controls: Measures to ensure that the system keeps a record about sources.
• Attributability controls: Measures to ensure that data will be retrievable.
• Data validation controls: Checks performed by the computerized systems to ensure the validity and quality of clinical information. 

 What are some of the main security and data quality features EDC systems must have?

•  The internal clock system should consistently show the current date and time.
• Secondly, an Access Control Module should be available to track each user’s access (e.g., login, logout, time out, login error).
• An activity registry must be in place to track the activity through the EDC pages.

Written by: Jackson Sukumar

B. Pharmacy

ClinoSol id: 180/1022