PSP and Health authority cases

[Srinivas Ramesh]

Hi,

Could any of you please provide your opinion or suggestion for the following scenario in entering the cases in safety database.

The PSP vendor nurse reports an AE/ADR related to suspect drug to client as per PSP agreement timelines, but it is also stated that they have reported the same to MHRA via yellow card system as per their nursing guidelines.

In this situation, the client captures the information as PSP case in their safety database and processes the case and reports it to MHRA.

After few days or weeks an AE report is notified by MHRA to MAH with similar/same AE, same AE onset date, with similar patient age or age group and gender of the patient. This might be result of yellow card notification from nurse.

So in this situation, should the MAH consider the latest report received from MHRA as another case and document it in safety database as this is received spontaneously from health authority or should MAH identify it as duplicate information as it was already received from PSP. Please note MHRA will not provide patient initial or DOB as it is marked as private, so MAH will never be able to confirm that both patients are same.

As per GVP module VI, we are supposed to capture AE information based on type of receipt of information. Hence, i think that both AE reports needs to be captured in safety database. One as PSP case and the other as Spontaneous (Health authority report).

Any guidance on this topic from this forum will be very helpful.

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