Investigator Initiated Clinical Trials Toolkit

The following documents are provided to assist you in setting up your investigator initiated clinical trial at a NALHN site. These tools comply with Good Clinical Practice and NALHN Research Governance.

Forms are intended to be partially completed electronically, printed and completed by hand.

  • Investigator Site File (DOCX 56KB) - An Investigator Site File (ISF) should be established at the beginning of the trial. The Table of Contents template describes the documents to be stored by the Investigator to demonstrate compliance with GCP and regulatory requirements. All essential documents must be retained in the ISF and be available for audit.
  • Site Contact List (DOCX 42KB) - Provides auditors/sponsors or site staff information on how to contact site study staff
  • Delegation of Authority Log (DOCX 50KB) - Allows the Principal Investigator to document the delegation of tasks. The documentation of the signatures and initials of all site clinical research staff allows monitors/auditors to match signatures on source documents with those on the delegation log; to determine who did what on the study and that delegated tasks match those performed by each person.
  • Participant Screening Log (DOCX 42KB) - To document identification of subjects who entered pre-trial screening.
  • Participant Enrolment Log (DOCX 38KB) - To document chronological enrolment of subjects by trial number
  • Participant Identification Log (DOCX 43KB) - To document that the investigator keeps a confidential list of names of all participants allocated to trial numbers on enrolling in the trial. Allows investigators to reveal the identity of any trial participant if required for safety