EMA R3 requirements detailing the mandatory null flavour codes.

[Inam Hassan]

Hi,

With the updated EMA R3 requirements detailing the mandatory null flavour codes.

Can we ask how other MAH’s have adapted their ICSR processing to differentiate:
1. Between UNK and ASKU i.e. if Day 0 source information has not fulfilled the 20 mandatory null flavour codes – is this being processed as NASK or UNK
2. For serious cases meeting expedited reporting requirements, where the null flavour codes have not been established, and follow-up attempts are being processed – how are the ASKU versus NASK versus UNK being captured (as they will not be clear until follow-up is received).
3. Where follow-up attempt with the reporter is not possible (lost to follow-up ICSR scenarios) – this will possibly be known only after the third and final follow-up attempt and therefore majority of ICSRs will be coded with ASKU?

[janine.gavinp82@gmail.com]

Dear PIPA Member,

Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

Unfortunately, no one within the Committee are unable to advise on this, we would therefore advise that you seek further clarification from the
ICH guideline E2B (R3) – questions and answers document

We apologise for not being to provide guidance on this occasion.

Kind regards
PIPA

[Author]

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