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.
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 |
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.
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.
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.
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:
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.