Complying with GCP, as easy as ABC? IT providers to clinical trials to be directly regulated

The Government has confirmed in its recent Response to Consultation for Legislative Proposals for Clinical Trials that it will be extending the direct application of Good Clinical Practice (GCP) to IT providers to sponsors of clinical trials. It is an unsurprising move (and one widely supported by consultation respondents – 85% agree with the proposal) given the direct impact that IT systems can have on patient safety, data integrity and compliance with clinical trial protocols. 

So what does it mean for IT providers to sponsors of clinical trials?

IT providers potentially within scope are those providing, operating and/or managing systems used to generate, collect and manage clinical trial data and/or used to provide trial management or randomisation capabilities. The proposal will apply to both on premise and “as a service” providers and both should: 

• Get GCP ready. Many IT providers will be familiar with the GCP requirements and regulators’ guidance via contractual flow downs demanded by trial sponsors. However, there will be IT providers who managed to previously resist a full flow down who will now need to comply as a matter of law or via any existing contractual commitments to comply with “applicable law”.                                                                                                                                                        
• Revisit negotiating positions. The direct regulatory compliance burden may mean a change in impact of certain provisions, most notably the change in law provisions and associated cost allocation. As the risk to trial sponsors remains the same, we expect to still see indemnity cover, deemed direct losses, limitation of liability carve outs and audit rights being hotly negotiated.                                                                                                                                                        
• Watch this space. The Government has said that it will "explicitly state in legislation that electronic system providers will be required to comply with GCP" and that it will produce additional guidance to accompany this legislation. There is no ETA on when this will happen or the extent to which the guidance might deviate from that which currently is pitched at trial sponsors.