Safety Checks On Concom Med Doses

Hi all,

I was wondering if other CTUs routinely collect concomitant medication dosing data and if so, what levels of checks you apply to these data to ensure that occurrences of overdosing would be promptly identified; for example automatic database validations, or other manual checking processes with medical input, etc.?

Whilst I realise that validating concom med data is problematic, my understanding is that CTUs have an obligation to act on any data they receive which would be indicative of a safety issue, and failure to do to so would be viewed as unacceptable by the MHRA.

I would be really grateful to know how other CTUs approach this problem.

Thanks,

Katie

 

Katie Neville
Head of QA & Regulatory Affairs
Liverpool Clinical Trials Centre (LCTC), University of Liverpool

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