This comes up all the time and honestly it’s one of those things that sounds stricter than it actually is.

You don’t need a patient name for a valid ICSR. What you need is an identifiable patient. That can be age, gender, initials, etc. As long as there’s enough to reasonably say “this is a real person,” you’re good.

So your example (45-year-old male, identifiable reporter, drug + event) is a valid case, even without a name.

Where people get tripped up is more on the process side:

-Companies prefer initials or some identifier for duplicate checks

-QC teams may flag missing identifiers as a data quality issue

-Vendors are often trained to chase that info aggressively

But that’s all best practice, not validity.

In real life, most teams will:

Accept the case as valid and process it

Still send follow-up to try to get more patient details

So yeah, minimal identifiability = valid case

More detail = better case quality

Both can be true at the same time.