GeneralIs DDC or EDC Better for Collecting Data in Clinical trials?

What Are the Main Differences Between DDC vs. EDC?

Before we begin discussing the main differences between EDC and DDC software, we need to have an understanding of what they actually are. DDC stands for direct data capture, which refers to the collection of data in real time. This means that, during a clinical trial, at the exact moment data needs to be collected, it is done right there and then. The data points are collected instantaneously and simultaneously entered into the DDC tool.

EDC stands for electronic data capture and refers to the data collection method that records data points at various points during the clinical trial. These data points are later transcribed, either electronically or manually, into the EDC tool. Because this method of collecting data involves a transcribing step, the data has to be verified before it can be used.

What Are The Advantages of DDC Compared to EDC?

One of the main benefits of DDC is that the data are collected at that exact moment in time while the patient is still there, allowing for corrections to be made. If any errors have occurred, the process can then be repeated, and accurate data can be collected. Another advantage of DDC is that the data collected is a lot cleaner which means there are fewer questions about the validity of the data points.

DDC skips the process of transcribing all of the data points and inserting them into the EDC tool manually. This reduces the chance of human error and increases the accuracy and reliability of the data collected. It also dramatically increases the efficiency of the data collection process when data is automatically sent into the DDC tool in real time. Using DDC also removes the verification step of the source data, which is only required if data has been transcribed, as is the case with the  . DDC helps save time and allows trials to be done much more efficiently and with less hassle.

How Are Existing Data Records Incorporated Into A DDC System?

For any clinical trial, all of the patient’s existing medical information, including their medical history, medications, and laboratory data, will need to be inserted into the records involved in the research. The method of doing this is, in fact, very similar to how data is collected using the EDC approach. All of the data will need to be transcribed manually into the DDC tool, whether electronic or in paper form.

Again, much like the EDC method of collecting data, this transcribed data will need to be verified before it can be used. However, once this process is complete and the data has been merged into the DDC system, any new data points collected will be instantly incorporated into the new system used in the research. These new data points will not need to be verified either because they have not been transcribed manually, thus increasing productivity and efficiency in the data collection process.

How Are Data Collected Using DDC Incorporated Into A EDC System?

Unlike using the EDC method of data collection, a DDC system will collect all of the data in real time and automatically upload it. A DDC system also assembles a lot more different types of data compared to the EDC data collection method. Any video, audio, handwritten notes, and scanned images are all collected in real time, which is then consolidated into a single data set. This data set is then uploaded into the DDC system, ready for review from any location. This method eliminates the need for any source document verification (SDV), any paper, or a transcribing process.

The complete data set created by DDC has been cleaned at the time of creation and therefore requires no transcribing process to be integrated into an EDC system. It also skips the verification process making it super easy and hassle-free to incorporate the data points into the EDC system.

So, What Method Is Overall Better For Collecting Data In Clinical Trials?

Research through clinical trials is down throughout the world, and they are becoming more digital every day. Vast amounts of money, time, and energy are spent on processing data that offer almost nothing to the results of the research.

With a DDC system, the speed at which data are collected and uploaded increases significantly, and the quality and reliability of the data are also enhanced. It skips the transcription and verification process saving time and cash, and speeds up the research process. In the long run, this will increase how fast new treatments become available for patients and will improve the overall health of the population.

The process of gathering data in clinical trials has been a hot topic over the years. Regulatory bodies have been going back and forth in deciding which approach is in the best interest of the people. The EMA and the FDA, along with other bodies involved in regulation, have created manuals and guidance on how this new approach should be used. It suggests a shift in the way in which data will be collected in the future as the regulatory bodies appear to be embracing this new and efficient approach that speeds up the collection of data in clinical trials.

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