What You May Not Add

Part of Pharmacovigilance and Drug Safety (PV) Training: Processing the Case.

About 1 minutes. Free, in your language, no account needed.

The case is the reporter's account, structured

Your job is to make the report assessable without making it something the reporter did not say. There are three specific things not to add.

Do not add a diagnosis

If the reporter describes symptoms, the case holds symptoms. A clinician on your team may later add a medical assessment, clearly attributed as such. A case processor turning "chest pain and breathlessness" into "myocardial infarction" has fabricated a data point.

Do not add a causality you were not given

The reporter's causality assessment belongs to the reporter. The company's assessment belongs to the company, and both are recorded separately because regulators read them separately.

If the reporter offered no opinion, that is what the field says. "Reporter did not assess" is information. A default of "related" or "not related" filled in to complete a form is not.

Do not resolve a contradiction silently

If the reporter says the event started two days before the first dose and also says it was caused by the drug, both statements go in the case. Note the inconsistency and follow it up. Choosing the version that makes a tidier case is the same error as inventing data, applied to the material you were given.

Why this discipline holds

Every one of these shortcuts makes an individual case read better and makes the database worse. Signal detection works on thousands of cases. It can tolerate a great deal of missing data. It cannot tolerate confident data that is wrong, because nothing downstream can tell the difference.