Commercially Sponsored Trials

While sponsors are free to contact clinicians directly for initial trial interest and/or feasibility, it is recommended Investigators reach out to MCTC to provide guidance. 

Before a sponsor can provide detailed information about a study they will require a Confidential Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) be signed.

MCTC team can assist with all aspects of the sponsor feasibility process, from arranging the CDA/NDA to providing detailed information to the sponsor on the site capabilities and start up timelines, so please reach out to the MCTC Business and Operations Manager ([email protected]) and/or the MCTC Clinical Trial Nurse Lead ([email protected])

Please note that the CDA/NDA must be made out to MCRI and a draft submitted to MCRI Legal ([email protected]) for review and signature.   The CDA/NDA should not be signed by the Principal Investigator. For more information about Confidential Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) please visit the MCRI Law & Order intranet page.

Once the sponsor has provided the study protocol it is recommended a feasibility assessment is performed by the Principal Investigator/Research Lead to evaluate the practicality and readiness of the site for the successful initiation and execution of each new clinical trial. This includes a review of key factors such as patient population, site capabilities, site capacity, regulatory environment, recruitment potential, and overall logistical considerations.

If you require any guidance for the feasibility of a new CST, please reach out to the MCTC Business and Operations Manager ([email protected]) or the MCTC Clinical Trial Nurse Lead ([email protected]).

While the sponsor drives the Site Selection Visit it is important that the Principal Investigator/Research Lead use this opportunity to further evaluate the study for feasibility/practicality. 

For guidance on the Site Selection Visit, please reach out to either the MCTC Business and Operations Manager ([email protected]) or the MCTC Clinical Trial Nurse Lead ([email protected]).

The clinical trial start-up involves all the initial steps needed to prepare for the beginning of a clinical study. This includes selecting and approving study sites, obtaining regulatory and ethics approvals, preparing and finalizing study documents (like protocols and consent forms), setting up contracts and budgets, and training the study staff. These activities ensure that everything is in place so the trial can begin safely, ethically, and in compliance with all regulations.

Budgets & Contracts

MCTC has established a Schedule of Services and Fees for CSTs and is responsible for reviewing annually.   A copy can be provided upon request.

MCTC provides budget and contract preparation services for Commercially Sponsored Trials, for which the fee for the service is built into the Site Start Up Fee.

For nodes who have the relevant experience and wish to remain independent for budget and contract negotiations we recommend the Research Lead joins the Clinical Trial Manager Forum convened by MCTC who meet bimonthly.   Please contact the MCTC Business and Operations Manager for further details ([email protected]).

Ethics Submissions

MCTC has established a contractor agreement between MCRI and Cancer Trials Australia (CTA) for the provision of Ethics Submission services for Commercially Sponsored Trials.   CTA has more than 5 years of experience in the preparation of Ethics Submissions to the RCH HREC for Commercially Sponsored Trials.   Their fee is fully cost recoverable from the budgeted start-up fee for each trial.

CTA will also prepare major amendment submission on behalf of the study team as required.

If you would like to make use this service for your trial please contact the MCTC Business and Operations Manager ([email protected]).

Site Governance

·         Supporting Department Approvals

·         Department Ethics and Research Platform (DERP)

·         Site Specific Authorisation (SSA)

·         Florence Electronic Investigator Site File (ISF)

·         Access to EMR for monitors

For guidance on any of the above systems or processes, please reach out to the MCTC Clinical Trial Nurse Lead ([email protected]).

In general, participant visit payments are tracked by the trial Sponsor using the study Electronic Data Capture (EDC) and are due for payment once the visit data has been entered and verified by the Sponsor.   The sponsor will either request an invoice from MCRI for visit payments due, or they will provide a recipient created tax invoice (RCTI) and so pay automatically. 

For all other study payments, MCTC has established the MCTC Finance Tracker which enables study coordinators to keep a record of when administrative fees, unscheduled visits and other invoiceable items are to be invoiced according to the Clinical Trial Research Agreement.   For more information, or if you would like access to this tool, please contact the MCTC Business and Operations Manager ([email protected]).

Some sponsors are utilizing third party vendors (ie Greenphire) for trial payments which generally automates all study payments and allows sites to upload invoices.  It is important these systems are set up correctly from the outset and so if you need any assistance in communicating this to the sponsor, please reach out to the MCTC Business and Operations Manager ([email protected]).

MCTC has trained casual Clinical Trial Assistants available who can assist with the archiving of your study and whose hours will be recoverable from the Study Close Out Fee.  If you wish to utilize this service, please reach out to the MCTC Clinical Trial Nurse Lead ([email protected]).