A clinical trial has various stages, from seeking patients to collecting data to analysis, drawing conclusions, etc. Each stage is important in ensuring your trial is a success. This article focuses on the data collection phase of a clinical trial. The data collection process requires data, as the name suggests, and patients. The patients, the subjects involved in your study, will relay this data by filling in Case Report Forms (CRFs.)
Thanks to digitization, CRFs have improved to Electronic Case Report Forms (ECRFs.) With ECRFs, patients fill in the data they need digitally rather than through paper CRFs. This begs the question; how does the innovation, ECRF, help clinical trials? Read on to find out how its design helps clinical trials.
ECRF design is beneficial by:
1.Giving You Control
As a medical researcher, you more or less have an idea of what you want from your clinical trial, including the possible result. This increases the need to control the data collection process to ensure you get all the data you need. How you Design CRFs will help you gain control of your clinical trial.
One of the design features that give you control is mandatory sections. You’ll insert the mandatory instructions on the questions that give the most important data you require. This design eliminates situations where patients submit their forms, leaving blanks on data your trial needs. This renders your data collection process futile, forcing you to repeat the whole process.
However, refrain from marking all sections as mandatory. Give your patients room to decide whether to answer all the other questions or leave some blank. You don’t want them to feel controlled, an action that might not sit well with some patients. It might make them abandon the trial, which you don’t want.
The other design feature that gives you control is pre-coded answers. Examples of pre-coded answers are yes/no, excellent/poor, or ratings from 1-5. These kinds of answers enable you to collect quantifiable data. You want to collect this kind of data to enable easy analysis. You’ll make more valid conclusions with quantitative rather than qualitative data, enhancing your trial.
2.Reducing Time Spent
Time is a key aspect of a clinical trial. You want to deliver results quickly and move on to the next trial as soon as possible. By doing this, you’re increasing the chances of improving the general public’s health.
ECRF, in general, promotes automation by reducing, if not eliminating, manual data entry. The lack of manual data entry reduces the chances of errors in collected data. The use of edit checks, as previously stated, also reduces errors. Therefore, your team will spend less time doing data cleansing. You’ll be done with your clinical data within no time, which is a plus.
Quality is important in clinical trials. Public health is dependent on the findings of clinical trials, from new medications to illness cures. Therefore, you should undertake all procedures with utmost care. The ECRF design can assist you in achieving the quality you desire.
This design allows you to incorporate edit checks in your ECRFs. Edit checks will ensure the patients only fill in the data you require without errors. You have to input the settings of the answers you expect, including format, to your ECRF to enable edit checks. Should a patient deviate from this setting, the system will notify the patient of the error. This enables the patient to make the necessary changes and conform to your requirements. You’ll end up with error-free data you can utilize for your clinical trial, increasing quality.
As part of ECRF design, it’s always advisable to add instructions to your ECRF form at the beginning and in the sections within. The instructions help your patients better understand the questions and the type of answers you expect from them. You could also give an example for understanding purposes. There’s less likelihood of a patient misinterpreting the questions and giving you answers that don’t help your clinical trial with the instructions. You’ll both be on the same page, ensuring quality data collection.
Cost is often the cornerstone of any clinical trial. Without funds, you can’t kickstart your clinical trial. You want to minimize expenditure as much as possible to avoid running out of funds midway. An ECRF design can assist you in reducing expenses. One of the design features of an ECRF is minimizing the number of pages on your form. You can achieve this by collecting the data you need for your clinical trial. Fewer pages reduce the size of your ECRF digitally. In most cases, with ECRFs, you’ll send these forms to your patients’ email accounts or provide a platform for them to access. You must have internet data to send these documents. As previously stated, fewer pages result in less data size; hence you won’t consume much data when sending the ECRFs. You’ll reduce your operational costs, even if it’s by a small margin; it’s still a saving.
The discussion above has shed light on how ECRF design helps clinical trials. With this information, you’re better placed to decide whether to adopt the ECRF invention. However, ensure you make the right decision. Suppose you’re already using the innovation. This information has helped you know the minimum services you expect to get from your ECRF adoption.
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