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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