Clinical Data Validation is at the core of every large scale clinical trial. Accurate and quality data is fundamental to the success of any clinical trial. As a clinical researcher, CRO, sponsor, or anyone involved in medical research, you must ensure the reliability and integrity of the data collected for research purposes. The manual collection often leads to discrepancies in data. Therefore, stakeholders involved in clinical research are increasingly looking for electronic data capture systems that help ensure the quality and accuracy of clinical data.
You need to have robust mechanisms in place to ensure the integrity of your data. Data validity is essential because it helps researchers and other medical professionals make effective decisions. Let’s take a comprehensive look at the world of data validation in clinical trials.
Overview of Clinical Data Validation
Data validation is a process that involves an amalgamation of processes that ensure the quality and integrity of data being obtained and used in a clinical trial. The processes are carried out to ensure that the data is attributable, which means there is clear documentation of the data source. Also, the data should always be legible, contemporary, and original. If the data fulfill the criteria mentioned above, it is considered valid.
Why Does Data Need Validation
As mentioned, data validation is critical in a trial setting. Your data needs to be accurate and original because it directly impacts your research and the ultimate conclusions. Clinical data has a significant impact on treatments across the globe. If your data is incorrect, there is a high chance it may harm patient health and the population in general. Various regulations require data to be validated before use, and research institutes invest heavily in data validation techniques to ensure compliance with rules and regulations.
The Actual Process
Data validation is a four-step process, and clinical researchers should follow the guidelines diligently to ensure the integrity and reliability of their clinical data. The first step is the planning phase, where key stakeholders involved in clinical research decide upon the techniques, tools, and technology used in the data collection process and the procedure used to validate or invalidate results. All checks, processes, codes, and other relevant material are appropriately documented.
The second part of the process involves understanding and implementing the planned procedures and tests within the research organization’s clinical database system. The third part of the data validation process is ensuring the inputted data’s validity. Invalid results are either fixed or discarded. The last process involves locking the system to prevent further amendments without official approval.
How Can EDCs Help?
Clinical trial data management solutions are a good way to ensure data validity and integrity. If you’re looking for a quality service provider who can help you with a robust system, check out ClinicalPURSUIT. We have established ourselves as one of the leading providers of EDC software for a clinical trials. We also provide quality Randomization and Drug Supply Management, Electronic Patient-Reported Outcome Software, and EDC system for Patient Studies. Contact us to schedule a free demo today.