Table 8 Issues with clinical operations
From: An investigation into the factors affecting investigator-initiated trial start-up in Ireland
n | % | |
|---|---|---|
Time between site identification and activation | ||
< 4 weeks | 2 | 16.7 |
1–6 months | 5 | 41.7 |
6–12 months | 3 | 25.0 |
1–2 years | 1 | 8.3 |
2–3 years | 1 | 8.3 |
Any issues during site identification? | ||
No | 11 | 91.7 |
Yes | 0 | 0.0 |
Not applicable | 1 | 8.3 |
Any issue with site selection | ||
No | 10 | 83.3 |
Yes | 0 | 0.0 |
Not applicable | 2 | 16.7 |
Any issue with site activation | ||
No | 10 | 83.3 |
Yes | 1 | 8.3 |
Not applicable | 1 | 8.3 |
Any issue in study monitoring | ||
No | 9 | 75.0 |
Yes | 2 | 16.7 |
Not applicable | 1 | 8.3 |
Any issues in contract negotiation | ||
No | 9 | 75 |
Yes | 3 | 25 |
Duration of contract execution | ||
1–6 months | 9 | 75.0 |
6–12 months | 2 | 16.7 |
> 1 year | 1 | 8.3 |
Issues with ethical approval | ||
No | 9 | 75 |
Yes | 3 | 25 |
Issues with regulatory approval | ||
No | 11 | 91.70 |
Yes | 0 | 0 |
Not applicable | 1 | 8.30 |