Clinical Trial Research Support Hub

1.1 Feasibility

This stage refers to understanding whether you can do a study. If you have been offered the opportunity to provide feedback on a commercially sponsored trial then you will be sent a Confidentiality and Disclosure Agreement (CDA) to sign before you can review any study related information. Once returned, the protocol or a protocol synopsis will be provided to you to review. To understand the feasibility of a trial you need to consider the following:

• Do we have access to the study population described in the inclusion & exclusion criteria in the protocol? If so, how do they present to us and how will we recruit them?
• How many of these participants do we have access to? At what frequency?
• How many are likely to participate and over what period of time?
• Are procedures in the study design standard care or additional to standard of care? If so, what are they and will they collect valuable information to support the outcomes of the trial?
• What information is provided about the Investigational Medicinal Product (IMP), device or intervention? Do we know enough about the IMP (i.e. have your also been given and Investigator's Brochure, Product Information or Summary of Product Characteristics to review)? Is it addressing an unmet need?
• What other clinical trials have been conducted to date? What is the safety profile and how it is metabolised? Are there any concerns?

When the Principal Investigator and research team have evaluated the study they will respond back to the sponsor, with their level of interest in the study and potential numbers to contribute to the global or national trial.

The sponsor may request further information, as well as a Pre-Study Visit (PSV) or Site Selection Visit (SSV). These are half day visits where the sponsor meets the local research team, reviews facilities and discusses experience and expectations, to determine if they are an acceptable site to conduct the trial.

It is also an opportunity for the research team to discuss the protocol, learn more about the intervention, discuss ethics, governance, training, budgets and any perceived issues or concerns about going ahead with the trial.

By the end of the visit, the sponsor will know if the site is a 'preferred site' to conduct the trial. The trial site will also know if they would like to be involved.

1.2 Start-up

Once selected as a site, the clinical trial process moves into the Start-Up phase. In this phase there are several process occurring in parallel, however it is defined by:

• Developing a plan for the clinical trial, which includes understanding the following dates and milestones: final protocol, ethics and governance approval, first patient visit (FPV), recruitment start date and period, last patient visit (LPV), close out.
• Budget and Contract negotiations, including trial resource allocation by the site.
• Ethics: Whether you are lead site or a participating site
• Governance: Ensuring all supporting departments have been consulted, and any fees or particular needs for them to support the trial are included in the budget.

It’s important to appreciate that start up means a site has agreed in principle to conduct the trial, but organisational authorisation is not given until Research Governance Authorisation has been provided. Therefore, start-up is also defined by evaluating the ability of the site to conduct trial at every step of the start-up process, appreciating that as more information is provided about a trial it may not be feasible. For example, the timelines may be unrealistic, the budget insufficient, a site may have concerns, or a supporting department may not have the resources to fulfil their role in the trial.

Download a customisable feasibility and start up worksheet template here.

1.3 Conduct

The Conduct phase of the Clinical Trial Process, can be defined by the First Patient Visit (FPV) and Last Patient Visit (LPV) at your site, and can be divided into two further stages of:

a) Recruitment:

The recruitment period is the timeframe for all sites to enrol the participants, as outlined in the study protocol, to meet the objectives of the trial. This phase can also be called the 'accrual period'. A set timeframe for recruitment is usually defined globally, with minimum and maximum numbers to be recruited for each site defined in a site contract; however recruitment is globally competitive. This means that while a recruitment period is proposed, you may in fact have much less time if another country, or another site nationally, enrols participant quickly.  

b) Maintenance:

This phase is defined by the end of recruitment and the last participant visit. All participants have been enrolled and you are now focusing on performing the trial visits, as required by the protocol. It's usually a time to allow reassessment of your resourcing to ensure the FTE support for the trial is adequate, and determine future trial needs for the unit.

1.4 Close-out

This is the final stage of the Clinical Trial Process and is marked by a site Close Out Visit (COV). This can occur from several months to a year after the final patient visit at your site and involves final review of data, regulatory binders and preparation for archiving of the study data. Archiving can only occur once the final study report, outlining the results of the trial have been provided to the trial site.

Download a customisable Archiving template here.

4.1 International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP)

ICH-GCP or 'Good Clinical Practice' guidelines are the internationally accepted standard for designing, conducting, reporting, and recording of clinical trial research. GCP training is a mandatory requirement for anyone involved in clinical trial research and is available online via GROW here: Good Clinical Practice (GCP) Training

Course information:

This ICH E6 GCP training meets the minimum criteria for ICH GCP identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. A certificate will be provided on completion of the training and is valid for 3 years. Please upload your certificate of completion on GROW.
When you are required to recertify in 3 years, a link to upload your certificate of completion will be provided. 

Target Audience:  

New and existing staff involved in conducting clinical trials at Barwon Health are required to complete ICH-GCP training. 

New clinical trial and clinical research staff including Principal Investigators, Associate Investigators, CT Managers, CT/Research Coordinators, Research Assistants, HREC members and Research Development Unit Staff are required to complete the full A-CTEC GCP training. 

Staff whose GCP training certificate is about to expire may complete a refresher course through Global Health Network. 

The RDU may also ask existing researchers to complete A-CTEC GCP training via GROW as risk management following audits or incidents.

If GCP training does not appear as mandatory training within your GROW account, please ask your manager to add you to the researcher list in GROW. 

Duration: A-CTEC = 6-8 hours. GHN = Refresher 1 hour

Face to Face training is also available, at cost, through external providers which provide details on applying the practicalities of GCP in the context of a trial. External Training providers used by Units at Barwon Health are below:

4.2 International Air Transport Association (IATA) Dangerous Goods Training

IATA Dangerous Good training is required if you are a shipper of Dangerous Goods by Air for any of your projects. Training is provided by the Civil Aviation Academy of Australasia (CAAA) in various format.  More information can be found on the CAAA website, or you can contact them by telephone on (08) 6180 7939.

4.3 Other Training Resources

You may also like to consider the following training for your research staff where appropriate, for example: 

• First Aid for Non-Nursing Coordinators
• Redcap