Tools for Investigator Initiated Clinical Trials

The following tools are provided to assist you in setting up your investigator initiated clinical trial at the Lyell McEwin Hospital.  These tools comply with Good Clinical Practice and NALHN expectations.

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

 

Title of Document

Purpose

Template

Investigator Site File: Table of Contents

 

 

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.

Table of Contents

Site Contact List

Provides auditors/sponsors or site staff information on how to contact site study staff

Contact List

Delegation of Authority Log

 

 

 

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.

Delegation Log

Participant Screening
Log
To document identification of subjects who entered pre-trial screening

Screening Log

Participant Enrolment
Log
To document chronological enrolment of subjects by trial number

Enrolment Log

Participant Identification
Log
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

Identification Log

 

Return to Research at NALHN