2. Site readiness

Health Service Support

To run a sustainable clinical trial unit and invest in new clinical trials/teletrials, hospital executive engagement and support is important.
Clinical trials are beneficial to health services and their communities, so it’s important that health services recognise the value of clinical trials.

This document outlines the value, importance and benefits of clinical trials to health service executives.

Build a network

The most important aspect of research that you will not find standardised in any official template is the ability to build and sustain professional and productive relationships with your colleagues.

Research is a team effort. It requires honesty, trust, respect and open communication between partners and takes commitment, time, effort and compromise.

Ways to build and maintain professional relationships with other sites in order to participate in teletrials:

  • Participate in regular multidisciplinary meetings with colleagues from other medical centres
  • Attend conferences and networking events. National clinical trial organisations run yearly conferences and have opportunities to join working groups about teletrials:
  • Offer to give presentations to other health services in your area of expertise
  • Actively seek out like-minded colleagues in your field
  • Meet with thought leaders and influential people within your organisation and seek their support
  • Meet with investigator groups and potential commercial sponsors – make it clear that you wish to conduct teletrials and would like to discuss the process further with them
  • Educate yourself about being a change management leader
  • Create formal memoranda of understanding between institutions.

Make a plan and set timelines

Setting up and running teletrials is a process that can take up to two years for a site with no previous experience. As with any endeavour relying on teamwork and multiple reviews of complex documents, you will need to sustain your enthusiasm despite unforeseen delays and setbacks.

You will need to establish a team who will be able to manage the process at your site.

A critical success factor involves engaging a designated project manager to guide and enact a timeline and allocate responsibilities covering initiation, planning, execution, monitoring and control and continuation of the teletrial process.

Define roles and responsibilities

Examples of some roles/delegations at trial sites:

  • Principal Investigator / Chief Investigator – PI (sits at the primary site)
  • Sub-Investigator / Associate Investigator – Sub I or AI (sits at the satellite site)
  • Trial Pharmacist
  • Project Manager / Study Nurse / Clinical Research Nurse
  • Project Manager / Clinical Trial Coordinator
  • Clinical Trial Assistant
  • Ethics and Regulatory Specialist / Coordinator / Manager
  • Finance Administrator / Coordinator / Manager
  • Contracts and Budget Coordinator/ Specialist
  • Start-Up Specialist / Coordinator
  • Research Governance Officer
  • Research Officer
  • Data Entry Administrator/ Manager

Complete mandatory staff training and documentation for conducting clinical trials

All staff conducting clinical trials must have evidence that they have completed their mandatory training. It is essential that staff follow correct procedures for training and record keeping to prevent harm to patients and fraudulent research outcomes.

Clinicians are responsible for seeking out their own GCP training.

GCP certification is valid for 2-3 years depending on which program you have completed. This must be kept current and certificates provided to sponsors. Staff GCP certificates are kept in the study site file.

Online Training (arcs.com.au)

GCP Training Free (pharmalessons.com)

All staff must provide a CV in their trial site file showing their education and experience in conducting clinical trials. Sharing the Principal Investigator’s CV with the sponsor is an essential first step for start-up activities. CVs are kept in the study site file.

Transcelerate BioPharma has a widely accepted template available here.

Clinicians are responsible for seeking out their own Dangerous Goods Regulations training.

Any staff involved in shipping blood and tissue for research purposes must have a valid certificate renewed every 2 years and provide this to sponsors. These training certificates are kept in the study site file.

Information about courses

Documents required to show a site has teletrial capabilities:

You will need to produce a Site Profile (also known as a Site CV), and have it available for distribution to potential study sponsors. It should be updated with the latest information at least yearly due to staff movement.

This is your site’s brand or shopfront. It needs to include sufficient information about your site’s capabilities, staffing, infrastructure and clinical trials processes.

Generally, suitable sites for partnership have access to:

  • Specialist medical staff
  • Pathology service
  • Radiology service
  • Trial co-ordinators
  • Pharmacy – preferably with clinical trial exposure or experience
  • IT capabilities: shared electronic site file, secure data transfer.

Under the teletrial model, satellite sites are not required to have access or resources to conduct all measures. For example, a site may be able to conduct 60% of all measures locally and the remaining 40% can be conducted at the primary site. This is still beneficial for the patient as they have potentially reduced their need to travel to the primary site by 60%.

For trials that are being run through General Practitioners or medical centres, the information would need to at least include medical and nursing staff, pathology, links to pharmacy and safety equipment available.

Example blank template based on Parkville Cancer Clinical Trials Unit (PCCTU)

Shared Investigator Portal (SIP) template

Regional Trial Network (RTN) Victoria has the site capabilities of eight cancer clinical trial units listed on their website here.

You must have a set of standard operating procedures (SOP) in place and available for reference by staff and sponsors. They should specifically address how teletrials will run at your site.

If you are already running clinical trials at your site you will most likely have these documents already but you may need to revise them to include provision for teletrials. Pre-existing SOPs may be transferred or adapted from established sites.

The Australian National Standard Operating Procedures for clinical trials, including teletrials, are the recommended SOPs for conducting teletrials.

It is the responsibility of the principal investigator/delegate to ensure all essential documents are collected prior to clinical trial initiation and maintained throughout the study. All essential documents will be filed in study-specific Investigator Site File (ISF) that may be physical or electronic.

For Teletrials, site staff at the satellite site (SS) are responsible for the collection and maintenance of the specific SS documents as defined in their SOP and for the provision of copies of these documents as required to the Primary Site.

See National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia, Appendix 8 for a template.

A list of delegated duties will need to be detailed in the Teletrials Supervision plan (see section 4 in the left-hand menu for further information).

The Satellite Site (SS) will maintain a separate delegation log in the SS Site File. The SS signs a hard copy and retains the delegation log.

A copy is then emailed to the Primary Site (PS) where the Principal Investigator will approve the delegation of duties in person or electronically using an approved electronic signature.

The SS will retain the original but a copy of the log will be provided to the PS with each change of staff.

Examples of delegation logs:

PCCTU Delegation Log

PCCTU Delegation Log Role task examples

PCCTU Acting Principal Investigator statement

You can use these templates to develop your own site-specific documents; please note the example documents have been made available for educational purposes only.

The above documents and templates have been provided by the Parkville Cancer Clinical Trials Unit (PCCTU). The VCCC Alliance would like to thank and acknowledge PCCTU for its contribution to the Teletrial Toolkit.

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