Electronic Data Capture, in the field of clinical trials, means a system that helps you collect clinical trial data in manners other than paper form, i.e. in electronic form. It has led to replace the traditional ways of data collection and streamlined its process. It has also accelerated the time it takes to market medical devices and drugs.

Frequently asked questions regarding EDC

1. What does EDC provide?

Answer: EDC provides the following:

• a graphical user interface (GUI) component for data entry.
• a validation component to verify user data.
• a reporting tool for examination of the collected data.

2. Who uses EDC?

Answer: It is used by life sciences organizations majorly defined as pharmaceutical, biotechnology industries and medical device in various aspects of clinical research. It is also used by hospitals and academic institutions which conduct clinical and observational studies.

3. How does EDC work?

Answer: Data is recorded on a paper document first and then it is transliterated into the system and stored in an electronic case report form (eCRF). Based on the edit checks programmed into the eCRFs, real-time checks on data are performed. In some cases the data is directly entered into the system, thus bypassing the need for paper documents.

4. What are the common functionalities of an EDC?

Answer: Query Management, eCRF designer, data entry, audit trail, data export, role-based permission.

5. How does EDC ensure security?

Answer: Users are allotted accounts in the system. Each account has an exclusive username, a password, and designated permissions. This sets a limit as to what a user can do and see within the system.

6. What is an audit trail functionality in EDC? How does it help?

Answer: An EDC system has audit trail functionality where every alteration made to data is followed. It helps to ensure that the integrity of the data is not compromised.

7. How does EDC minimize data entry errors?

Answer: Programming edit checks, which act upon data entry for mechanised review, helps avert invalid data from being entered into eCRFs. This results in lesser errors and helps maintain data quality and completeness.

8. What are the challenges addressed by an EDC system?

Answer: Switching over to an EDC system can help solve following challenges associated with other methods of data capture, such as:

• Ensuring compliance
• Reducing data entry errors
• Finding what you need and when you need it
• Efficiently managing time spent on data collection and review

9. What do Data Managers want in an EDC System?

Answer: Following are the requirements of an EDC system:

• A system that improves communication and sharing information with its users.
• Flexibility to allow for study of specific customizations and dynamic forms.
• Easy to recover data queries.
• Effective data cleaning and easy to update.

10. How is EDC software by Data+ beneficial?

Answer: Data+ Research EDC enables you to streamline your data collection process using graphical user interface, data validation and reporting tools for clinical research across Life Sciences.  It assures data accuracy and decreases the time it takes to collect data.

Using Drag & Drop and WYSIWYG technology, Data+ empowers you to build forms (eCRF) that match your specific research and workflow with complete flexibility and includes tools that ensure workflow logic.  Adding to this, powerful, real-time data integrity and data consistency tools across research groups.