Some colleagues and I were having a discussion about what is documented in patient notes when taking consent.

My understanding was that it ought to be documented that PIS given, time to review, consent obtained.

My colleagues felt that version numbers have to be written in patient notes. Whilst I accept that is good practice is that mandatory?

Are there any MHRA guidance on specific points that HAVE to be written in the notes?

I am only aware of the GMCs guidance on taking research consent (2013) which states on pg.12 to record 'key elements' of what was done in consent process. However there are no specifics of what should be documented in patient notes?