Trial Conduct

During the trial there are many activities that occur that require a clinical trial team with appropriate skills and expertise.

Each trial site must have a Site Initiation before recruitment can commence

This activity occurs at both the sponsoring institution (if it is recruiting participants) as well as each site participating in the trial. The purpose of the Site Initiation Meeting or Visit is to prepare and set up the site to conduct a study and must occur prior to patient recruitment.  

The Site Principal Investigator must attend the meeting together with as many members of the research team as possible. Representatives from any supporting departments should also attend, eg pharmacy, radiology, laboratories.  

During the Site Initiation meeting or visit, the following items should be discussed:

• Protocol, including eligibility criteria
• Recruitment procedure
• Monitoring plan
• Safety monitoring
• Trial intervention
• Laboratory tests, including shipment to central laboratory (if applicable)
• Data entry into the Case Report Form (CRF) or database
• Training requirements

The Sponsor-Investigator is responsible for giving sites the 'green light' to start recruitment once the Site Initiation Visit has occurred, and they are satisfied that the site is able to conduct the trial in accordance with:

• The protocol
• Trial-specific standard operating procedures
• Compliance with Good Clinical Practice (GCP) and any other local/national regulatory requirements

See Recruitment and Consent, Data Collection, Risk Management, Monitoring and Trial Progress Reporting for further information about trial conduct activities.

Guidelines

• NHMRC: National Statement on Ethical Conduct in Human Research
• NHMRC: Safety monitoring and reporting in clinical trials involving therapeutic goods
• NHMRC: Data Safety Monitoring Boards (DSMBs)
• TGA: ICH Guideline for Good Clinical Practice
• TGA: Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting