Post-Authorization Safety Studies - Recent Inspection Findings

The MHRA GVP inspectorate recently published their latest pharmacovigilance (PV) inspection metrics for the period from April 2019 to March 2020. The inspection metrics have been published since 2009 and are based on PV inspections carried out annually.

Critical findings in the conduct of post-authorization safety studies (PASS)

According to the inspection metrics, the agency observed significant breaches of the study protocol for the MAHs non-interventional PASS during an inspection at a study site. These breaches impacted the collection of data related to the primary and secondary study end points. Thus, there was no assurance of data integrity.

The critical findings identified during the inspection included in detail:

  • Outcomes of interest for the study had not been collected during the six-month follow-up phase after last dose administration and the long-term follow-up phase of patients
  • Data entry into the electronic data capture system was inaccurate or incomplete
  • Adverse events recorded in the patients electronic health records had not been recorded in the adverse events page of the case report form and there was no evidence of a seriousness or causality assessment 
  • Examples of delays in reporting serious adverse events to the MAH
  • No record of who performed the eligibility assessment for patients enrolled in the study and when they were performed
  • Signed consent forms were missing for three patients

The full metrics report is available on GOV.UK.

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