Sydney Health Partners has launched new resources to help clinical trial coordinators track, manage and run clinical trials, including a simple electronic documentation system that simplifies compliance with regulatory bodies.

The Electronic Clinical Trial Master Files (eTMF), developed in partnership with the University of Sydney Clinical Trials Support Office, provides a straightforward way to document clinical trials from study start up to close-out, to ensure each trial complies with state and national guidelines and regulatory bodies.

“Good documentation is essential for clinical trial management, but we know it’s not always a straightforward process,” says Joan Torony, Clinical Trials Project Manager at Sydney Health Partners, who created the original eTMF.

“The eTMF is designed to help you keep track of every aspect of your trial as required by Australian regulatory bodies including the TGA and the NHMRC, without having to start from scratch.”

Trials require a large amount of documentation to allow clinical triallists to recreate all related activity and ensuring a quality process throughout all trial phases.

“Using an eTMF to track your study allows you to easily check the status of TMF content in real-time, helping you keep track of what you’ve already filed in your eTMF and what is missing,” says Ms Torony.

Clinical trial coordinators can download the eTMF from the Sydney Health Partners website, alongside other resources to enhance clinical trial management.

Other support available includes checklists to track the progress of clinical trials, information about applying for ethics and governance in NSW, as well as strategies for recruiting participants.  

Following an SHP-led 2020 analysis that identified several clinician, patient and operational issues that impact recruitment success, Sydney Health Partners is also conducting a pilot project with a centralised recruitment officer, shared between three musculoskeletal trials.

New resources will be added over time as part of SHP’s strategy to support translational research.

“Sydney Health Partners is committed to removing or reducing barriers to the translation of research into clinical practice. Clinical trials are a vital piece of this translation journey, but we know from experience that many groups that run trials need more support,” says SHP Research Director, Associate Professor Angela Todd.

“This initial suite of resources aims to provide that support – offering guidance and direction to smooth the journey of commencing and managing a trial.”