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Table 2 Costs of simulated trial activation

From: Improving readiness for recruitment through simulated trial activation: the Adjuvant Steroids in Adults with Pandemic influenza (ASAP) trial

Action Item/staff Time (mins) Cost
A. One-off costs at Coordinating Centre
Internal planning meeting(s) Multiple staff 360 £690.60
Mock activation planning meetings Multiple staff 120 £206.76
Development of simulation documents Trial manager 120 £39.88
QC of website QA manager 120 £44.02
Review training material Trial manager 60 £19.94
Activation of IT systems Database programmer 60 £17.72
   Sub-total £1018.92
B. Costs of site simulation Coordinating Centre
Planning meeting with site Multiple staff 60 £115.10
Distribution of documents Trial administration 40 £8.79
Activation of IT systems Multiple staff 120 £35.44
Obtain and despatch IMP Multiple staff 50 £14.73
Issue green light Trial manager 10 £3.32
Follow-up questionnaire Trial administration 20 £3.85
Non-staff expenses Cost of IMP/packaging   £132.50
  IMP delivery   £60.00
  Trial team transport   £6.00
   Sub-total £379.73
Research site
Planning meetings Multiple staff 60 £107.57
Complete online training Multiple staff 20 £156.16
Complete documents/forms Multiple staff 25 £183.13
Recruit patient to study Research nurse 5 £12.64
   Sub-total £459.50
Central pharmacy
Planning meetings Specialist pharmacist 60 £22.89
Receive and dispatch IMP Specialist pharmacist 5 £47.70
QP release QP 60 £65.72
   Sub-total £136.31
   Total £1994.46
  1. IMP Investigational Medicinal Product IT information technology, QA quality assurance QC quality control, QP qualified person