As monitors we sort of live by this motto and we always try to remind our sites of this, we do so in order to help protect the subjects, their site, and the Sponsor of the study all at the same time.
We have had this discussion numerous times over the years. Many believe that the informed consent form is documentation enough. On the other hand, others would like to see all consent processes documented with a progress note, in addition to the consent document.
This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.