We are a non-commercial organization sponsoring a phase III double-blind randomised trial, undertaken in hospital maternity departments. The IMP is given during labour.

The standard clinical procedure at several of our sites is for women to be discharged from hospital with their labour notes (i.e. they take them with them), which are then used during follow up appointments with their community midwives. Notes are eventually returned to the hospital, but this can take several weeks and in some cases the notes are never returned, for example if the woman loses them or fails to return them.

We are undertaking a risk assessment in terms of what this means for source data and IMP accountability, as it means that source data (including drug charts and documentation of the labour, at one site), will not be available to for several weeks and in some cases not at all. I was wondering if anyone else has experience of studies in maternity that have raised similar issues and how they have overcome these issues, or the regulatory stance in these situations?