Resources

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.

Clinical Trials SOPs

Informed Consent SOP

Uploaded 10 Oct 2017

Informed consent in the context of a research study is a process of information exchange, which involves the giving of written and verbal information, the discussion and clarification of the information and the taking of the participant’s verbal and written consent. Participants or their legally acceptable representative must have been informed of all aspects of the trial that are relevant to their decision to participate, and then have given their informed consent voluntarily prior to participating in any study procedures.

Clinical Trials SOPs

Delegation of Duties SOP

Uploaded 10 Oct 2017

It is a requirement of Good Clinical Practice that personnel employed to work on clinical research studies are qualified to do so by education, training and experience.