EMA highlights problems with clinical trials file maintenance

The European Medicines Agency (EMA) has warned that the increasing complexity of clinical trial data files is creating problems for auditors and regulators wanting to ensure good practice.

In a detailed report on handling legally mandated trial master files (TMF), EMA said: ‘As trials can be large and complex involving many departments and contract research organisation, the management of the file can become difficult.’

It said pharma organisations were using electronic files to assist, but this has also introduced new technical challenges.

‘Together these issues have led to organisations being unable to provide the master file in an appropriate way for management and audit/inspection purposes,’ EMA said. Sometimes inspectors have even had to extend investigations.

EMA said companies should know where all file components are held since difficulties in locating documents are common.

Sometimes investigators have been presented with a summarised ‘artificial TMF’ and thus failed to provide adequate direct access. EMA reported instances of company staff being proffered as system users for electronic TMFs who were unable to locate documents requested by the inspector.

EMA said another problem was quality control failures – such as missing pages, incorrect documents and poor quality scans – with the result that inspectors had no confidence that the electronic TMF was accurate.