Data for a clinical trial is collected using a case report form (CRF), questionnaires and/or other measures and assessment that constitute trial-specific tests. Most trials collect data using paper, where the data is recorded and subsequently manually typed out into a database or system.
Manual data entry hinders and slows down the progress of a clinical trial due to its timely nature, notwithstanding the fact that there is a strong likelihood of errors in data, which has a debilitating effect on research. Simultaneously, there is a rise in costs for employing administrative staff who perform the manual entry and process the data. Research shows that it takes about 60 minutes to manually enter 4 CRF’s, leaving little or no room to examine a large enough quantity of data in real time. Furthermore, the paper needs to be stored somewhere, which adds to storage costs and further time consequences in trying to retrieve records from filing cabinets.
Collecting data electronically is one option. Making the shift to electronic data collection is not easy, however. There are further costs to consider as well as training and giving enough time to acclimatize to a new method of data collection.
There is now available an alternative method of collecting data, using digital pens. In summary, using a digital pen is exactly the same as using a regular pen with one significant difference. As a result, one can continue to collect data using the pen and paper method (and thus not having to adjust to a new style of data collection), without having to worry about the pangs of manual data entry, physically storing and retrieving paper and the costs and time consequences that come along with it. Sounds ideal? Read on…
A digital pen works exactly like an ordinary pen, therefore one is not required to relinquish paper. The difference lies in a small camera that is attached to the pen. As you are completing the CRF/questionnaire, the camera is taking multiple pictures of your pen strokes. The digital pen thus transforms the handwritten notes into a digital format and readable text for validation. Completed forms are stored electronically. As a result, administration and processing costs are reduced, it is easier to trace a form back owing to digital storage, data is accurate and the latest data is available for analysis and interpretation.
The data that is initially stored on the pen can be routed back to a central database or server for storage. This is ideal for instances where data collection for a clinical trial is taking place at remote locations. What’s more is that there is no need for an internet connection as data transfer can happen via Bluetooth or a USB. Research staff no longer need to return to base and subsequently manually type of data from the paper, they simply dock the pen to the laptop and the data is there, available for analysis and monitoring.
Therefore, key benefits include:
- No manual data entry
- No physical storage of paper
- Forms are traceable
- Data is available in real time
For a free and practical demonstration of the value of digital pens, which goes into further detail into its technical capabilities or if you have a general enquiry, please get into contact.