Table 3 Corporate considerations for facilitating or coordinating CTNs
From: Activities supporting the growth of Clinical Trial Networks in Australia
If an answer to any of below is ‘no’, CTN may be better suited to facilitating model | Yes or No |
|---|---|
1. Does the CTN want to take on role of GCP Sponsor and/or offer a trial coordinating centre service (internal/outsourced) to its members? | Â |
2. Can the CTN access funding/develop sufficient trials to establish and maintain a trial centre? -Need at least 2 people or 1.2 FTE to cover leave etc. even if only one trial. -n/a if outsourcing trial conduct. | Â |
3. Does the CTN have industry-experienced personnel that will allow simultaneous development of CTN-specific processes while not delaying trial start up? | Â |
4. Is expertise and resource available in the CTN for some or all of the following: statistical planning and analysis, database programming, data management, trial coordination, and (possibly) abiding by GCP Sponsor requirements? Providing secure data management can be expensive. | Â |
5. Can the CTN provide clinical trial insurance (this may also be provided by the trial sponsor for IITs as well as local Institutional insurance)? | Â |
6. Will the CTN need to be a legal entity if acting as sponsor? | Â |