Processes & Procedures

Standard Operating Procedures (SOPs) are detailed instructions that outline who, what, where, when and how of a specific activity. Quality SOPs perform the following functions in clinical trials

• Enhance research quality, efficiency, data reliability and participant safety
• Create operational efficiency
• Ensure everyone aware of their responsibilities and how to perform a process
• Assist to prevent non-compliance with the protocol, GCP and local requirements

Melbourne Children’s Clinical Trial SOP Working Group  is responsible for developing, maintaining and implementing SOPs that apply to all trials sponsored by MCRI and where a Melbourne Children’s campus partner (RCH, MCRI or UoM Department of Paediatrics) is a Trial Site. These SOPs, as well as other supporting resources, can be found on METIS.

Other groups are responsible for developing other categories of SOPs as follows:

MCC department/group – Apply to all trials in a specific department/group

Central Coordinating Trial Team – Apply to a specific MCRI-sponsored IIT at the Sponsor level

Site Team – Apply to a specific externally-sponsored trial at the site level

SOPs need to be regularly reviewed to ensure they still align with current requirements, including local policies, procedures, and relevant regulations.  At a minimum this should be every three years. SOPs must be managed using a standardised document management and control process. This ensures:

• All staff within a clinical trial team and contributors are working on the same document versions during document development/updates.
• All staff are using the most recent and approved version of a document.
• Efficiency in filing and access to documents throughout the trial life cycle

Refer to MCTC121 SOP | Document Management and Version Control for the process to use for trial SOPs at Melbourne Children’s.

Refer to CRDO Human Participant Research Coordinator Forum: Clinical Trial Standard Operating Procedures (past recording and slides available for internal staff) for further information about responsibilities for developing SOPs in clinical trials at Melbourne Children’s.

Please use the following resources when developing SOPs:

MCTC001 Guidance | Creation of New Standard Operating Procedures

MCTC076 Guidance | Electronic file naming conventions

MCTC121 SOP | Document Management and Version Control

MCTC111 Template | Standard Operating Procedure (SOP) / Guidance