FDA Flags Safety Reporting Lapses at U.K. Clinical Trial Site

FDA has cited a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during a late-stage clinical trial of a respiratory syncytial virus (RSV) vaccine. In a just-posted untitled letter dated 8/5/2025, FDA said an inspection of the Synexus North East Clinical Research Centre at Hexham General Hospital in Northumberland, U.K., identified multiple violations related to the conduct of a Phase 3 trial evaluating an investigational RSV vaccine candidate developed by GSK.

The agency inspected the site under its Bioresearch Monitoring Program and reviewed the center’s oversight of a randomized, placebo-controlled study testing the efficacy of a single dose and annual revaccination of the RSVPreF3 OA vaccine in adults aged 60 and older.

One of the most serious issues cited by FDA involved the failure to record and report adverse events in accordance with the trial protocol and federal regulations. Investigators found that several adverse events experienced by a trial participant — including hypomagnesemia, hypophosphatemia, worsening hypertension, prolonged QTc interval and constipation — were not entered into the electronic case report form until 4/2024, more than a year after the site became aware of them in 1/2023. The protocol required such information to be recorded within five calendar days.

FDA also tagged the site for failing to report a participant’s cause of death within the required timeframe. Although the site determined in 5/2022 that the participant died from bronchopneumonia and complications related to surgery and aspiration, the information was not entered into the study’s expedited adverse event reporting system until 4/2023 — well beyond the protocol’s 24-hour reporting requirement for serious adverse events, according to the letter.

The inspection also raised concerns about the integrity of clinical trial documentation after a staff member reported that signatures on study logs appeared to have been falsified. According to FDA, an internal review of 55 swab processing and shipping logs found 18 containing questionable signatures. In 12 instances, the signatures were attributed to a clinical research coordinator who was not present at the site on the dates the logs were signed.

The agency said the site’s internal investigation concluded that another individual likely signed the forms but did not name the person responsible and failed to interview the suspected employee. FDA inspectors learned during interviews that the employee believed to be responsible had been suspended in 2/2023 and dismissed the following month for misconduct.

The FDA said the investigation appeared incomplete, noting that the site reviewed only a small portion of the total 259 swab processing logs and did not expand its review to other study records despite the employee having study responsibilities from mid-2021 until early 2023. “Your incomplete investigation to adequately identify the full extent of signature falsifications and potential other misconduct raises concern relating to the integrity of the subject data collected at your site,” the agency wrote.

Additionally, FDA investigators also found that monitoring staff signed off on several shipping logs before they had been completed by site personnel. In some cases, logs were certified as reviewed despite missing required initials or containing incorrect visit information.

FDA said the deficiencies could compromise the reliability of clinical trial records and compliance with federal regulations governing investigational drug studies.