Quality control is applied at different stages of the clinical data management process and is generally prescribed by SOP. The FRC collects adverse events reported during the clinical trial, but there is a separate process that ensures that serious adverse events are reported quickly. The clinical data manager must ensure that the data is coordinated between these processes. If the data entered does not meet the validation rules, a data consultation can be conducted at the analysis site where the clinical trial is conducted in order to obtain a clarification of the entry. Data queries should not be at the forefront (i.e. they should not suggest the correction that should be made). In the case of electronic FRCs, only site employees can edit data inputs with appropriate access. In the case of paper FRCs, the clinical data manager applies the response to the data consultation in the database and a copy of the data consultation is kept on the survey site. If an item or variable misscaled or there is a query to make, a “discordance” or query will appear. A DTA must be set up by a member of the research office`s contract team prior to data transfer Clinical Data Management (CDM) is a critical process in clinical research that leads to the creation of high-quality, reliable and statistically based data on clinical trials. [1] Clinical data management ensures the collection, integration and availability of data at the appropriate quality and cost. It also supports the conduct, management and analysis of studies throughout clinical research, as defined by the National Institutes of Health (NIH).
The ultimate goal of the CDM is to ensure that the research findings are well supported by the data. Achieving this goal protects public health and confidence in commercial therapeutic drugs. To respond to information management, it is necessary to put in place a data transfer agreement covering the transfer of data between institutions. Normally, we assume that in a clinical trial, only anonymized data is transmitted, there is often data that is collected electronically but outside the scope of the eCRF. This data includes key laboratory results such as ELECTROGs, PK/PD data and others. In this blog, we will take a look at some important thoughts regarding the management of electronic data transfers and each subsequent integration into the EC`s central database.