Trend Analysis In PV

I was wondering if you could share your experience and processes on trend analysis and central monitoring of SAE data in your units?

Currently we provide the SAE data for the TMG where it is detailed the number of SAEs per site and includes the number of participants recruited per site for the TMG to discuss.

For some trials we would prepare the SAE data and group the events by MedDRA SOC and/or provide a table of total events by MedDRA SOC.

Furthermore, in your units is there a SOP that covers trend analysis and central monitoring or is it incorporated in other SOPs?

We have a central monitoring SOP, but are in discussion process to see if a separate SOP that will look at safety data should be developed or if existing one should be expanded.

 

I look forward to hearing from you.

Thanks,

Marinela

Specialist in Pharmacovigilance and Safety 

Centre for Trials Research, Cardiff University

 

 

M. Zagorscak

[Author]

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