The electronic CRF enables entry of data into an underlying relational database.
For a clinical trial utilizing a paper CRF, the relational database is built separately.
This is sometimes summarized as making sure clinical databases are fit for their intended use.
In general, database validation is a type of software validation.
In both cases, the relational database allows entry of all data captured on the CRF.
All computer systems used in the processing and management of clinical trial data must undergo validation testing to ensure that they perform as intended and that results are reproducible.
Validation of a clinical database is a structured, documented process to show that the database follows regulatory requirements and performs other functions it needs to perform.Where available, standard CRF pages may be re-used for collection of data which is common across most clinical trials e.g. Apart from CRF design, electronic trial design also includes edit check programming.Edit checks are used to fire a query message when discrepant data is entered, to map certain data points from one CRF to the other, to calculate certain fields like Subject's Age, BMI etc..There are a number of regulations and guidances requiring validation of electronic health records systems, which include clinical databases – see below for a list of the more important ones.The underlying reason for the regulations is that clinical databases affect clinical data, which affect treatment decisions, which affect patient health.The clinical data manager plays a key role in the setup and conduct of a clinical trial.The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.The Clinical Data Interchange Standards Consortium leads the development of global, system independent data standards which are now commonly used as the underlying data structures for clinical trial data.These describe parameters such as the name, length and format of each data field (variable) in the relational database.The data management plan describes the activities to be conducted in the course of processing data.Key topics to cover include the SOPs to be followed, clinical data management system to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedures to be applied.