Each clinical trial needs a protocol and a patient information and consent form, but most trials require other essential documents to conduct a clinical trial efficiently as specified by ICH GCP.

The Coordinating Principal Investigator for a trial is ultimately responsible for these documents, though in practice the implementation of these processes often is strongly supported by clinical trial coordinators, technical specialists in clinical trial conduct.

Further information about participant information sheets can
be found in the clinicaltrialsNSW
toolkit and on the InFORMed PICF
website.