Resources

Clinical Trials SOPs

Principal Investigator: Clinical Trial Letter of Agreement

Uploaded 30 Jun 2018

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. 

Clinical Trials SOPs

Service Level Agreement Template for the inclusion of third party service providers in a Clinical Trial

Uploaded 30 Jun 2018

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. 

Clinical Trials SOPs

Suspected research fraud SOP

Uploaded 10 Oct 2017

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.

Clinical Trials SOPs

Hosting A Regulatory Inspection, or Sponsor / HREC-initiated Audit SOP

Uploaded 10 Oct 2017

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

Clinical Trials SOPs

Archiving SOP

Uploaded 10 Oct 2017

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

Clinical Trials SOPs

Clinical Research Training SOP

Uploaded 10 Oct 2017

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

Clinical Trials SOPs

Research-related Adverse Event reporting SOP

Uploaded 10 Oct 2017

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

Clinical Trials SOPs

Study Closure SOP

Uploaded 10 Oct 2017

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.

Clinical Trials SOPs

Source documents and case report forms SOP

Uploaded 10 Oct 2017

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).

Clinical Trials SOPs

Non-compliance reporting SOP

Uploaded 10 Oct 2017

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.