Study participants hospital notes
It is a requirement of ICH GCP (Good Clinical Practice) that an entry is made in the medical notes of individuals participating in a clinical research trial. This may be achieved by handwriting in the medical notes or using a template.
Details required to be documented are:
The Research and Development Department has prepared a template which can be used to label study participants' notes; these labels must go inside the patients' notes.
This template is for use with Avery Parcel labels L7165 which can be ordered through the EROS system.