In pharmacovigilance, case processing is a fundamental activity. It provides data for the analysis of adverse effects that allows to detect new safety concerns and to periodically assess the benefit to risk ratio associated with the use of a pharmaceutical product. The precision and quality of safety data processing, also from the medical point of view, is crucial for ensuring correct analysis and undertaking corrective actions in timely manner, which in turn helps to safeguard the health of the patients and allows safe use of the drug.

On June 23, seQure hosted a complimentary webinar on delivering quality case processing in pharmacovigilance operations. Continue reading to discover the best practices in case processing and common sources of bias.

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Why it is important to ensure the highest quality in case processing?

Case processing is a vital activity in pharmacovigilance because it allows different stakeholders like patients, healthcare professionals and competent authorities, to exchange huge amounts of safety data. Case processing includes the following steps:

  1. Receipt of a Case Report
  2. Registration of a Case Report
  3. Validation of a Case Report
  4. Triage
  5. Duplicate Check
  6. Data Entry
  7. Quality Control of Data Entry
  8. Medical Assessment
  9. Transmission to Authorities or Partner
  10. Closure
  11. Archiving

Ensuring the quality of data during case processing is vital. Correct performance of case processing activities is the basis of successful data analysis, scientific assessment and decision-making which in turn allows to effectively protect public health. The good quality of data enables:

  • Optimal communication between Competent Authorities, Sponsors, Marketing Authorisation Holders regarding safety of medicinal products
  • Regulatory compliance
  • Effective analysis of safety data that is used for benefit / risk assessment and signal detection activities in order to safeguard patients’ health in effective manner

Common Errors in Case Processing and How to Avoid Them

There is a number of quality issues that pharmacovigilance personnel performing case processing activities encounter. The most frequent issues are:

  • Incomplete reports
  • Discordant data
  • Coding errors
  • Narrative: incomplete information, spelling errors and typos
  • Missing or inconsistent medical assessment

Incomplete reports

In our experience, there are three main types of Incomplete Report errors:

  • Missing adverse events/special situations;
  • Missing co-suspect drugs, medical history, lab data;
  • Missing medical review and assessment;

One of the most effective ways to avoid the problem of data incompleteness is to conduct regular training. This training should involve not only the staff who is doing case processing, but also pharmacovigilance operations, investigators, and clinical research assistants.

Moreover, the quality of AE/SAE report forms can be enhanced by requesting clarifications from the reporter, especially for serious unexpected ADRs.  We also advise to use checklists to collect missing follow-up information in order to assist daily work of pharmacovigilance team.

Discordant data

Another common error regards the inconsistency of data. One of the most common examples is the error in the gender of the patient. In this case, the structured field can feature “female” as gender, while the narrative has a reference to a male patient or vice versa.

In order to avoid such mistakes, we advise to configure automatic data check in the security database. In this way all inconsistencies are automatically detected and reported. It is possible to set automatic control to prevent the user from continuing the work until the inconsistency is resolved.

Coding errors

Medical coding is essential for preventing spelling errors, incorrect abbreviations or non-standardised terms, but its most relevant function is to standardise and organise scattered terms into a standard parent category, which is essential for effective safety data analysis.

An appropriate and clear source of data allows to avoid coding errors. However, pharmacovigilance professionals can sometimes receive inaccurate or unclear information and abbreviations:

  • Congestion – the type of congestion is not clear (nasal, liver, sinus, pulmonary…)
  • Pain – the type of pain is not clear
  • MI – it is not clear whether MI stand for myocardial infarction or mitral incompetence

In such cases, we advised to request clarifications directly from the reporter. If the clarifications are not exhaustive, the use of lower level terms (LLT) would be appropriate. It is also useful to consider “MedDRA Points to Consider” document, as it contains many useful examples grouped by type coding errors.


Another common error type is an error in narrative when key information present in the case narrative is missing from the structured fields. It is crucial that all information in the narrative is correctly coded in the relevant structured fields, as this allows pharmacovigilance professionals to assess the cases quickly and facilitate consistent data retrieval.

A narrative of high quality is created with the use of auto-narrative function of safety database. Moreover, personnel who works on case narrative should have a good knowledge of English language and should also turn on spell check in their word processor while they are writing the case narrative.  Finally, it is important to involve a second person to perform a Quality control.

Missing or inconsistent medical assessment

Clinical medical assessment of cases is a vital integrated process that is performed in order to identify a diagnosis, ensure that diagnostic procedures have been carried out, identify a suspect drugs and consider alternative causes of adverse events. Therefore, clinical medical assessment should always be consistent and complete.

How to Achieve Quality Case Processing

Case processing is a vital activity that serves as a base for decision-making in pharmacovigilance. If it is performed with precision, it allows pharmacovigilance team to analyse the safety data correctly and take corrective actions in timely manner, making sure that the drug benefits the patients in the best possible way.

There are several strategies that can help to increase the quality of case processing:

  • Clear written Standard Operating Procedures.
  • Additional trainings for personnel who may receive or process safety reports (e.g. clinical development, sales, medical information, legal, quality control).
  • Clear and well-designed safety data collection forms.
  • Quality Control performed by a second person of all data entered in database.
  • Periodic checks on random samples of cases entered in database. This can be either a complete check or a check of the selected critical fields.
  • KPIs monitoring and CAPAs in case of deviations.

How Can seQure Support You with Pharmacovigilance?

Our pharmacovigilance team boasts more than 25 years of experience. We offer to our customers a complete portfolio of drug/medical device safety and risk management services for the collection, monitoring, assessment and analysis of safety information and the detection of new safety concerns.

We leverage our decades-long experience and expertise to maximise your product potential whilst ensuring patient safety. Case processing in post-authorisation and clinical studies is our specific expertise. Our case processing team guarantees high quality thank to:

  • Trained Safety Data Managers
  • Dedicated senior team members that perform Quality Control and mentoring
  • High attention to the details
  • Certified Eudravigilance experts

Are you looking for support with your pharmacovigilance operations? Send us an RFI for a personalised proposal via the contact form.

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