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Compliance In Focus
Posted by Rachel Silver-Kessler on Fri, Feb 12, 2021

What To Look For In An Electronic Data Capture System

 

In the past decade, electronic data capture systems have become widely adopted to the point that most studies now use them.

electronic-data-capture-system

And as more studies have transitioned to remote monitoring activities, they have become even more essential.

Only 12% of clinical research professionals IMARC surveyed said they frequently used remote monitoring prior to the pandemic. Now, 60% said they frequently conduct remote monitoring visits. Of those survey respondents, 11% said they had added an electronic system in the past year to support remote monitoring. Another 27% said they had implemented file-sharing software.

However, there are many different systems that can be used for electronic data capture, each with varying features.

If you are considering EDC software or re-evaluating your current system, here are five factors to consider.

Electronic Data Capture System Characteristics

The FDA’s guidelines for electronic records (last updated in April 2020) are intended to promote the “authenticity, integrity, and confidentiality” of those records by using the appropriate controls.

To achieve this, the electronic data capture system must meet the following criteria:

Records the Origin of the Data

According to the FDA, data can be entered into a data capture system in the following ways:

  • Manually, by typing it directly into the system
  • Automatically, by transmitting it from an electronic device
  • Directly from electronic health records
  • By transcribing it from paper or electronic sources into the system
  • From patient-reported outcome instruments

In any case, it must be clear where the data originated. For instance, if data is obtained from patient-reported outcomes, the audit trail should reflect the subject entered the data.

If researchers are transcribing data from paper or another electronic source, they must maintain that original source and make it available to an FDA inspector upon request.

Protects Records Throughout The Retention Period

Electronic records may need to be stored for long periods of time, depending on the type of study and post-market surveillance requirements.

The EDC system you choose should securely store these records for as long as you need to retain them. It should also make it easy to retrieve data when you need it.

Allows For Secure Data Access

The EDC allows sponsors, CROs, and other authorized personnel to view clinical trial data conduct monitoring and data management activities, as well as verify data integrity.

These individuals should have secure access with their own usernames and passwords. They should also be properly trained to use the system, and that training should be documented. The system should allow you to disable log-in access for users at any time, including if someone ends their involvement with a trial early.

In addition, EDC systems should include safeguards against external threats, such as hackers or viruses. Backup and contingency planning information should be readily available from any EDC vendor.

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Maintains An Audit Trail

The FDA states that EDC system should use “secure, computer-generated, time-stamped audit trails” to record entries and any changes made to electronic data. Those changes should not obscure any previously recorded data.

Uses System Checks To Enforce Procedures

In addition to maintaining secure access, the software should enforce procedures, such as ensuring that only authorized individuals can sign records or alter data. It should also enforce data locks when in place.

Get Help Evaluating And Managing EDC Software

Finding the right electronic data capture system is just the first step. You will also need to configure it properly and ensure your team has the right procedures in place to protect patient privacy and data integrity.

IMARC Research can help you choose the solution that best supports your needs. Our team also offers a full range of data management services.

We can help you set up your system, train your team, review your data for any errors or discrepancies, and prepare you to obtain approval.

To learn more about how we can help, contact us today.

Topics: Clinical Data Management

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