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ULG’s Language Solutions Blog

Electronic Clinical Outcome Assessment (eCOA): Can it Improve Clinical Trial Data?

Electronic Clinical Outcome Assessment, more commonly known as ECOA, revolves around the procedure of capturing data electronically in clinical trials, as opposed to on paper. Many state that eCOA is built to increase the quality of study data considerably, whilst of course, meeting the regulatory requirements.

Coming up, we're going to discuss exactly how it does that, and the benefits it provides along the way.

Let's get started.

 

How Does eCOA Improve Data Quality?

A wide range of clinical trial stakeholders now consider eCOA as one of the most effective techniques when it comes to capturing high-quality, reliable data. Many sponsors, CROs, and regulators back them in this idea, and have also come to prefer it instead of the traditional, paper-based method.

Electronic Clinical Outcome Assessments use electronic reminders, alerts, animated compliance feedback, and dynamic, context-sensitive messaging. It captures data in real-time, delivering an improvement on data quality with reliable information on patient's experiences throughout trials.


 

The Benefits of eCOA in Data Quality

ecoa prevents inconsistency and conflictions 

Since electronic data collection uses logic and branching sequences in order to guide patients through the appropriate questionnaire, patients and site observers are prevented from skipping questions, or entering inconsistent data that conflicts.

 

Ecoa eliminates transcription errors

Paper clinical studies usually require site personnel to manually transcribe data into trial management systems, which leaves room for errors and other inconsistencies.

By capturing eCOA, the steps become automated. This eliminates transcription errors, along with any inconsistencies, missing data, and other data quality issues that become detected in real-time throughout the electronic data collection.

 

ecoa reaches global regulatory standards

The electronic data collection method ensures data is collected and reported according to the global regulatory standards. Unlike the paper method, eCOA data is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA). As it meets the fundamental elements of quality, regulatory queries are virtually eliminated when it comes to the capture of eCOA data.

Regardless of size, CROs and sponsors who continue to rely on error-prone paper diaries to capture vital patient outcomes may be dealing with unnecessary risks to their clinical trials. However, those who turn to eCOA data capturing benefit from regulatory compliance, improved quality in data, and an overall accelerated clinical development.

 

 

Life Science Language Solutions 

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