One of the key duties of researchers is to ensure that the captured research information is accurate and answers the Good Clinical Practice (GCP) regulations and requirements. Only this way a complete integrity of database and, respectively, results can be achieved. However, there are plenty of occurrences when this is somehow neglected or accidentally omitted. In this case, if the clinical trial information which is stored in the database is incorrect, the outcomes based on that information could be incorrect too. To fix and avoid such mistakes, researchers take advantage of the so called query management.
Let’s start by explaining what query is. It represents mechanisms used for retrieving data from a database. All queries include questions. These questions are entered to the database in a specific format which is predefined. However, it is really important to have a specific criteria which will help you to narrow down the data. Since studies always come with a lot of documentation with information, surely you will need to be selective in what exactly you want to be returned. So choose carefully how much information you want to retrieve and make sure you don’t select everything but just specifically required sections.
It is important to point out that some clinical, medical and pharmaceutical organizations still use paper-based documentations because the electronic formats are too expensive. As a result, this raises questions regarding query management and how it can be implemented in paper-based studies and electronic-based studies. In relation to this, performing query management procedures manually by using spreadsheet, for example, can turn into a time consuming process. What is more, it can even be further complicated because of accidentally removed data or inserted data which is inaccurate. The fact that the spreadsheet can be accessed by one person at a time additionally complicates the whole process.
In summary, the results of any clinical study are based on correct, balanced and quality data. In this sense, if the stored data suffers from inconsistencies, incompleteness or any other sort of incompliance with given regulations, this can have a negative impact on the whole trial. In order to guarantee compliant data, researchers implement plenty of operations, procedures and systems. One of them is the so called query management which represents a way of retrieving information from a database with precision and accuracy.
Clinical Data Validation is one of the topics that will be covered in our next webinar on Clinical Data Management Advanced Electronic Data Capture Systems. The webinar will discuss the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The online training session is certified and is taking place on 12-th November 2015. Hurry up and get the Early-bird registration until 5th November, 2015.
