This document summarises the roles and responsibilities under ICH GCP of a PI who is nominated to conduct a Clinical Trial on behalf of an institution. Elements can be added or deleted as appropriate to an organisation or institutions needs. 

This template helps to demonstrate the inclusions that should be considered when including third party providers such as Radiology providers or other ancillary services such as non core laboratories for the conduct of a clinical trial in line with protocol requirements. These documents may help with meeting local institutional governance requirements, noting they should be amended as appropriate to align with institutional requirements and do not serve to replace agreements already mandated by institutions who have similar documents in place. We always suggest you discuss this with your Research Governance Office or Research Office first. 

This document describes the steps to be taken if research fraud is alleged or suspected to be occurring in research studies being performed and to define the procedures to be undertaken in dealing with such a situation.

To describe the procedures and activities for facilitating a sponsor, regulatory authority or HREC-initiated site audit.
 

The purpose of this SOP is to define the local procedure for preparing clinical trial records and their subsequent transfer to an archiving facility.

To outline the procedure for documenting training undertaken by Clinical Trials Unit (CTU) staff.

To describe the procedure for the reporting and recording of research related adverse events.

To describe the procedure to formally close a study to recruitment, suspend a study or put a study on hold or close out a research study.

Source data is all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original or certified).

In accordance with clinical trials regulations, no person shall conduct a clinical trial other than in accordance with the approved protocol, as may be amended from time to time in accordance with the regulations; and the terms of the request for authorisation to conduct that trial, the application for an ethics committee opinion in relation to that trial, and any particulars or documents, other than the protocol, accompanying that request or that application.