It will focus on the implementation of the electronic system, including changes. During inspection, FDA will focus on:
• source data that are transferred to another data format or system to ensure that checks are in place and that critical data are not altered
• review SOPs, training and auditing to ensure that the system is functioning and is being used in the manner intended.
As a CRO we are often requested to manage “rescue” studies and transfer data from one system to another. This process is challenging and must be carefully evaluated with a risk assessment exercise, agreeing on output data formats and input data formats, detailed and documented migration process, develop mock-study tests to ensure that checks are in place and data is not altered during the migration , evaluation of implications on audit trail information etc
It is equally important to develop appropriate SOPs as well as system work instruction to detail processes and train resources on processes so that they can apply them correctly when building databases for clinical investigations.
