Biggest Surprises/Challenges With Safety Information

The Miraculous Revival: Navigating Discrepancies in Safety Data

In the pharmaceutical industry, managing safety information is fraught with unexpected challenges and, in our 21 years as a global provider of clinical and post marketing drug safety services, it’s safe to say we’ve witnessed our fair share of surprises.

Using our years of auditing experience in performing Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPV) audits, as well as gap-fill analysis and pre-qualification assessments, our White Gloves Audit Group has compiled a collection of unexpected findings to help guide you away from common pitfalls:


Unexpected Challenges – Incorrect Safety Entry:

Patient Died and Recovered: Instances where patients are reported as deceased and later found to recorded as ‘recovered’ later within the report.

Future Date of Onset for the Reaction: Reactions documented as having occurred at dates in the future, as opposed to in the past or before any medication has been given.

Reaction Resolved in the Past: Contrastingly, cases found where adverse reactions are recorded as having resolved before they were reported to have started.

200-Year-Old Patient: Reports featuring patients with implausible ages, such as being over two centuries old, which warrant a place in the record books!

Male Pregnancies: Yes, recorded in the safety database, a male pregnancy that went to term.


Mitigation Strategies:

Robust Data Validation: Implement comprehensive data validation processes to catch and correct anomalies before transmission.

Advanced Training: Provide detailed training for staff on data entry and anomaly detection to prevent errors at the source.

Automated Alert Systems: Use automated solutions with built-in alerts for detecting improbable data, such as extreme ages or future dates, to flag issues immediately.

Regular Data Audits: Conduct periodic audits of safety data to identify and rectify discrepancies systematically, with clear audit trails to enhance audit preparedness. This should be part of any routine Quality Management System (QMS).

Clear Reporting Guidelines: The safety data may be correct, but what if it was not reported on time or to all of the Regulatory Agencies it should have been? There is a need to develop, maintain and distribute clear guidelines on how to accurately report and document adverse events, including handling exceptional cases, to ensure a consistent approach companywide.


These measures are essential towards ensuring accuracy and reliability in safety reporting and preventing serious regulatory findings during inspections, whilst also safeguarding against the potential legal, financial, and reputational consequences that are directly associated with non-compliance.

With over 75 years of senior auditor experience performing GCP and GPV audits against multinational legislation requirements, the number of unexpected findings we still find during inspections underscores the importance for Companies to take on these proactive measures and employ robust mitigation strategies to achieve greater levels of compliance.

Don't let unexpected findings compromise your integrity — schedule an introductory meeting today and let us guide you towards achieving and maintaining the highest standards of pharmacovigilance compliance.

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