Suspected research fraud SOP
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.
Hosting A Regulatory Inspection, or Sponsor / HREC-initiated Audit SOP
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.
Clinical Research Training SOP
To outline the procedure for documenting training undertaken by Clinical Trials Unit (CTU) staff.
Research-related Adverse Event reporting SOP
To describe the procedure for the reporting and recording of research related adverse events.
Study Closure SOP
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 documents and case report forms SOP
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).
Non-compliance reporting SOP
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.
Informed Consent SOP
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.
Delegation of Duties SOP
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.