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4. Supervision Plans

Supervision Plan Overview

The teletrial supervision plan outlines the relationship between a Primary and Satellite Site through the allocation of all teletrial activities, communication, data transmission and documentation. It’s important to note that while the supervision plan outlines the allocation of teletrial activities, it does not replace the delegation log.

Steps to a supervision plan

  1. Primary Site and Satellite Site collaborate on the supervision plan.
  2. All sections are completed with location and supervision of all trial activities defined.
  3. The plan is signed and endorsed by both the primary and Satellite Site.

Key abbreviations used in Supervision Plan:

Abbreviation Definition
CRC Clinical Research Coordinator
CRO Clinical Research Organisation
HREC Human Research Ethics Committee
IMP Investigational Medicinal Product
PS Primary Site
RCCC Regional Clinical trial coordinating centre
Rep Representative
RGO Research Governance Office
SS Satellite Site
TH Telehealth

Schedule of events

The supervision plan is designed to outline each item in the schedule of events and identify which site will conduct each item/procedure. The PS and SS should review and discuss the schedule of events. Tasks can be allocated in the supervision plan by a drop down menu specifying location.

SS Option This activity may be conducted at the SS
SS location only This activity will only be conducted at the SS
PS location only This activity will not be conducted at the SS
Not applicable This activity is listed in the protocol but not application to PS or SS

It is important to outline in the supervision plan which sites will be involved in each activity and how it will be performed. Tasks may be performed by teams or individuals at the assigned location. This is selected via a drop-down menu within the Supervision Plan.

Clinical Trial and Site Details

The next section of The Teletrial Supervision Plan requires Trial Protocol information and details of the Primary and Satellite Sites including names of the PS Primary Investigator and SS Associate Investigator.

Allocation of Activities

The supervision plan provides free text to list activities as they are defined in the protocol. Activities can be summarised under key headings such as blood testing or vital signs. Comment space is also available to define further details where needed.

Routine Clinical Trial Activities

This section of the Supervision Plan outlines activities across the life of the clinical trial and requires definition of the location of each activity and how it will be performed using the same drop-down categories as above.

Some things to consider and answer in the supervision plan include:

  • Who is responsible for data entry?
  • Who is responsible for participant appointment management?
  • Who will make clinical care decisions?
  • Who is responsible for safety reporting?
  • Who is responsible for research governance processes at each site?
  • How will communication between sites be documented for trial purposes and accountability?
  • How will screening work between sites (ie. Where will physical exams take place)?
  • How will the process of recruitment and screening work?
  • How will randomisation work?
  • How will funds be managed and disbursed?
  • How will the investigational product be received, stored, dispensed, administered, and destroyed by pharmacy?
  • How will data be securely transferred between sites.

The VCCC Alliance identified the need for a national supervision plan and has supported the Australian Teletrial Program (ATP) in its development.

The National Supervision Plan is the endorsed and recommended national template for supervision plans in teletrials.

More national resources can be found on the ATP website 

Please review the National Supervision Plan below.

National Supervision Plan

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