The EC has produced a consultation paper about clinical trial inspection procedures

Clinical trials lawyer Gene Matthews has welcomed the publication by the EC of its consultation paper relating to clinical trials.

Mr Matthews  is currently representing an individual who is living with a serious brain injury after being involved in a clinical trial.  He has previously acted for a number of people who were seriously injured following their participation in the infamous TGN1412 clinical trial at Northwick Park Hospital.

The Directorate General for Health and Food Safety of the EC has opened a consultation on matters relating to clinical trial inspection pursuant to Article 78(7) of Regulation (EU) No 536/2014, including:  

  • the detailed rules on clinical trials inspection procedures, in particular for the preparation, conduct, reporting, follow up, communication and record keeping and archiving of the inspections,
  • the co-ordination of the co-operation of the various Member States, and the follow up of the inspections,
  • minimum standards of qualification of inspectors, in particular regarding their education and training.

The consultation runs from 28 August until 24 November 2015 and the European Commission will take all responses into account as it develops the implementing legislation on detailed arrangements for clinical trial inspection procedures.

Mr Matthews, a partner in the consumer law and product safety team, said:

“The regulation and control of clinical trials throughout the European Community is of paramount importance to the safety of people who agree to participate in clinical trials.

"Adherence to the principles of good clinical practice is essential to maintaining and developing a safe, and hopefully thriving, environment for conducting clinical trials within the EU.

“I am pleased to note that safety features such as the qualification of clinical trial inspectors, and the rules relating to record keeping are all part of this consultation.”