Accurate and quality data is a cornerstone of every clinical trial. To be successful in your trial goals, you need to have appropriate mechanisms to ensure the validity of the data being collected. Electronic data capture systems have helped ensure the quality and accuracy of clinical data. Here we look more closely at data validation in this brief guide to data validation in clinical studies.
You need to have robust mechanisms in place to ensure the integrity of your data. Checking for correctness and completeness is critical as it helps researchers and other medical professionals make effective decisions.
Overview of Clinical Data Validation
Data validation involves a series of processes to ensure the quality and integrity of clinical data. The processes are carried out to ensure that the data is attributable, which means there is clear documentation of the data source. Furthermore, the data should be legible, contemporaneous, and original. If the data fulfill the mentioned criteria, it is considered valid.
Why Does Data Need Validation?
When operating in a clinical setting, your data needs to be accurate and original as it helps to evaluate the worth of your research and the ultimate product. Moreover, clinical data affect treatment plans across the world. If your data is not correct, then 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
The data validation process includes four steps. The first is planning, where the clinical trial organizers decide the techniques are used and the procedure used to invalidate results. The checks, processes, codes, everything is documented. Second, the planned procedures and tests are implemented within the organization’s clinical database system. The third part involves running data checks to ensure the validity of the inputted data. Invalid results are either fixed or discarded. The last process involves locking the system to prevent further amendments without official approval.
EDCs are a good way to ensure data validity and integrity. If you’re on the lookout for a quality service provider who can help you with a robust system, check out ClinicalPURSUIT. The company is known to provide quality systems that ensure the quality of your data. Furthermore, they also provide quality Randomization and Drug Supply Management, Electronic Patient-Reported Outcome Software, and EDC system for Patient Studies. Contact them to schedule a free demo today.