Clinical trials are studies conducted to test a medical intervention to determine whether a new treatment or prevention is safe and effective. Since information is critical, methods that ensure efficient data capture in clinical trials increase the chances of successful trials.
A key component of data capture in clinical trials is a Case Report Form (CRF), which captures data on the test subjects. The information recorded here includes patient characteristics, treatment group, health status, history, vital signs, treatment effects, lab reports and test results, and other relevant information during a clinical trial.
Data captured during a clinical trial will inform the safety and efficacy of the medical product on trial. Given the centrality of data in clinical trials, the capture process should be efficient and foolproof for this data to make sense.
To that end, here are five tips for efficient data capture in clinical trials:
- Use Electronic Data Capture Systems
Collecting and storing data using Electronic Data Capture (EDC) software is more suitable for efficient data capture in clinical trials. This data collection tool allows you to collect and store data electronically.
Most EDC systems have capabilities that include camera integration to collect image data, a checklist for data flow validation, data protection, data customization capabilities, and, most importantly, an integrated electronic Case Report Form (CRF) builder.
Some benefits of using EDC systems to capture data include the following:
- Improved Data Quality: Artificial Intelligence (AI) integration ensures accurate data collection by flagging results out from the specified parameters.
- Real-time Data: Enables accelerated completion of the clinical trial process by removing the travel and wait time for data managers, coordinators, and such. With EDC software, you can create forms, key in data, resolve the query and lock data in one system in real-time.
- Accuracy: EDC software ensures the accuracy and security of data due to audit trail functionality and role-based permissions, which tracks every change to the data.
- Ease of access: EDC systems store data in the cloud, meaning relevant parties worldwide can remotely access it. Also, with the availability of pertinent information in one place, it is easier to locate the relevant data needed at a particular time.
You will encounter many examples of poorly designed medical forms in many clinical trials . EDC systems, by autogenerating forms, will help solve this issue.
- Develop A Clear Data Collection Protocol
A data collection protocol must be in place to ensure efficient data capture in clinical trials. A data collection protocol informs the procedures you will use to collect and record data and include details such as the purpose of the study, test subject selection, the data collection schedules, and potential challenges.
- Regularly Monitor Data Quality
Quality data is supposed to be accurate, relevant, complete (in that it leaves no questions unanswered), timely, and consistent. When it comes to clinical trials, quality data is primary because it directly impacts the validity and reliability of study results.
You must ensure the quality of data collected by the study tools and personnel is relevant and consistent. Poor-quality data will cause serious negative consequences for the patient and the clinical trial.
Put a solid data assurance plan to ensure the data quality remains top-notch. Ensure you visualize anything that could go wrong during the data collection process and implement measures to prevent it. Also, incorporate quality checks into the data capture quality assurance plan to ensure the data captured in your clinical trial meets quality standards.
- Train Study Personnel
Study personnel collecting data with you must be conversant with, among other things, the study protocols, data collection procedures during the clinical trial, and the use of data collection systems.
They must also be trained in data handling and storage to ensure that the data is handled securely and complies with government regulations. The team should read from the same script to ensure proper communication between them and the respondents in the clinical trial.
- Ensure Data Security
One way to ensure efficient data capture in clinical trials is to ensure technologies are in place to secure the data collected. Clinical trial participants risk invasion of privacy and confidentiality breaches if their personal information falls into the wrong hands.
If these subjects doubt the security of their data, they will not easily yield information, leading to poor-quality or erroneous data. To ensure data is secure, consider using the latest encryption technologies, secure servers, and proper authentication requirements for everyone with access to the data.
- Parting Shot
Clinical trials are essential for the progress of humanity. For the trials to be successful, the data captured must be reliable and unambiguous. Try these actionable tips for efficient data capture in clinical trials.