28th Apr 2016, 05:23 PM
Defining the RSI for hospital commercial stock
We are reviewing our processes for Reference Safety Information (RSI) for studies where section 4.8 of the SPC is used to define this.
I am interested to hear of sponsor processes for studies where the NHS sites can use their own commercial stock, and therefore may often be using different generics or formulations. We have realised that sometimes the RSI in section 4.8 is slightly different in each generic formulation. We need to be consistent across the trial for SAR expectedness review, so what should we do about deciding which SPC will be used to specify the RSI in these situations? Also, when AEs are specified to be of different expected frequency across the different SPCs, what information do we add to the PIS?
The particular study I am thinking about is low risk, and the differences between the expected AEs on the different SPCs are fairly minor, but they do exist.
When we do decide to go with an SPC for a particular formulation for the whole study as required for the CTA, is it acceptable that we are using a different SPC to the one for the formulation which is actually being used at a site?
Thanks in advance for any advice!