In GCP inspection readiness activities, we frequently overlook the risk that clinical site inspections present for the sponsor.
It's critical, of course, that the site can demonstrate to the inspector that the source data support the analysis and the study was conducted according to protocol and regulations. But occasionally a question about study design, endpoint measurement, IMP, or other topic outside the site's scope will crop up during a site inspection. If the site can't answer the question accurately, there is a risk that the inspector will persist in a view of the protocol that could cloud his or her assessment of the validity of the data.
For example, during a clinical site inspection, the sponsor team received some frantic emails from the site that the inspector was asking why the investigator was reviewing a local assessment to treat the patients, and the sponsor was using a centralized assessment to assess the endpoint. The site was having a difficult time articulating why the investigator was evaluating the local assessment from one viewpoint to determine care, while the centralized assessment was evaluating the issue with a different lens.
In another clinical site inspection, the inspector asked a relatively simple question about IMP lots, but without a process in place to respond to the question, the sponsor team spent a significant amount of time emailing panicked questions and assessing conflicting answers (an emaelstrom?).
Due to these experiences and others, I always recommend that sponsors send a representative to attend site inspections and set up a back room to handle any sponsor questions that might arise.
Some sites or inspectors may object to a sponsor's presence at an inspection, but I've attended many site inspections as the sponsor representative, and there's been surprisingly little pushback. At worst, I've sat there for a few days with relatively little to do. More often, though, I've been able to help the site get answers to questions more quickly than if they were emailing across time zones, and in a few cases I've helped get responses to tricky questions before they could become full-blown misunderstandings.
Similarly, it is a good use of time for the sponsor to set up a "back room" to track and manage those questions when the liaison communicates them. That back room may sit for several days without any action, but when a question does come over the transom, there is a process for responding to it efficiently, involving the right subject matter experts.
The importance of handling third-party inspection questions is one of the reasons our Ready Room license includes unlimited inspections.
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.