Clinical trials are crucial in the medical field. They lead to the development of drugs and cures for illnesses. Hence achieving these milestones requires reliable data. Data collection is among the first stages of a clinical trial. You’ll need case report forms and the relevant people, referred to as patients, to participate in the process to get the necessary data. Previously, the laboratory forms, officially known as Case Report Forms (CRF,) were in the hardcopy format. However, digitization led to the development of Electronic Case Report Forms (ECRFs.) With ECRFs, the forms are available digitally. There’s no need for physical forms which can get lost at any time.
Quality data collection is of the essence. It begs the question, how does the innovation, ECRF, bring about quality in data collection through its design? Read on to find the answer to this.
High-quality ECRF improves clinical trial data collection by:
- Eliminates Errors
Errors are one of the factors that negatively affect clinical trials. With errors, you’ll draw wrong medical conclusions that’ll affect most of the population, which is undesirable. However, high-quality ECRF designs reduce, if not eliminate, errors during data collection. How?
You can design your form to accept only a given type of information. Therefore, should a patient filling in an ECRF input the wrong format, the system will notify them of the error and guide them appropriately. In no case shall any patient submit a wrongly-answered form, ensuring quality data for your analysis. You can find out more about ECRF design from various online sources to help you understand it better.
Also, ECRF eliminates manual data entry by your workers. With paper CRFs, your team must manually enter data from the patient’s forms into your systems. Many errors are likely to happen here, from missed entries to double entries. You’ll end up using inaccurate data for your analysis. However, since ECRF uses digital systems for filling in, your team will no longer have to enter data manually. They’ll use it as-is from the patients’ forms, minimizing the chances of errors.
- Reduces Data Collection Process
In most clinical trials, data collection is one activity that prolongs the process. Patients have to come to your facility and pick up the case report forms; for some, carry them, fill them out, and later bring them back. The back and forth consumes a lot of time, lengthening the process.
ECRFs change the narrative. The patients don’t need to come to your facility for the forms. All you have to do is give them access to your digital platform, through which they’ll access the case report forms. They’ll then fill them in appropriately and submit their duly accomplished files with the click of a button. Here, ECRFs reduce the process by almost half the time, which is desirable.
- Allowing Flexibility
Flexibility is vital during data collection. Some patients might lack the time or ability to stick to their schedules due to other commitments. Suppose you require the patients to fill in their CRF forms during the day when your research facility is open. There’s a patient that can’t spare an hour or two to come down and fill in your forms since they have to work or they live far away from your premises. Such patients are likely to abandon the process midway, which isn’t ideal for your clinical trial.
Your patients won’t experience this kind of inconvenience with ECRF. With the forms being digitally available, they can fill in the forms from wherever they are without necessarily coming to your offices. If they have many engagements, they can fill in the form on a ride as they head for a meeting. They can also do the same at night before going to bed. By allowing this flexibility, you won’t experience a situation where a patient abandons the data collection midway. None of them will see the forms as a burden since they can fill them at their convenience. It is a plus for your clinical trial.
- Gives You Control
Conducting a clinical trial is a sensitive undertaking. As previously stated, clinical trials lead to the development of new drugs and cures for illnesses. Therefore, you must collect high-quality data. At times, you have no control of the data you’ll get from your patients, as is often the case with paper CRFs. Patients might fill in only the information they want to give, which might not be what you need for your case study. You might abandon the clinical trial or repeat the data collection process, which is undesirable.
A high-quality ECRF design will give you control such that you get the crucial data you need for your trial. You can insert mandatory sections on the forms such that your patients have to answer these questions before submitting them. It’d help to use this feature on the data that your clinical study relies on to succeed. However, give them some room to choose whether to answer some questions; do this for the non-essential data.
Conclusion
The discussion above has shed light on how quality ECRF design improves the data collection process of clinical trials. It more or less proves that ECRF will bring about positive changes and efficiency in clinical trials. As a clinical researcher, you can finally decide whether to adopt this innovation for your clinical trials, thanks to this information. Be sure to make the right decision, factoring in both the process and your patients.
