Skip to main content

Table 1 Improvements following simulated trial activation

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

Activity Key observations Benefit from simulation
Communication 1. Prompt responses across all parties
2. Incorrect contact details identified
3. Concerns identified regarding resilience of cover in the event of absenteeism of key personnel associated with trial processes
1. Improved levels of communication between trial partners 2. Highlighted need for building greater trial resilience at all levels – key personnel have been identified and asked to organise appropriate pandemic cross-cover; e.g. 2 ‘deputy’ chief investigators have been ‘appointed’
Documentation 4. Outdated documents identified
5. Training material well received by clinical and research staff
3. Improved quality control oversight of trial documentation – all trial documents are now available from the ASAP trial website to enable rapid updating and dissemination in a pandemic situation; QC checks at pre-determined time-points to ensure version control of all trial documents has been added as a critical trial procedure for the Coordinating Centre
4. Confirmation of adequacy of trial-specific training material
Pharmacy 6. IMP storage arrangements questioned by QP
7. Stock Control System requirements a risk to randomisation sequence
8. Time frames for delivery of IMP not stipulated in ‘Agreements’
5. Clarification and confirmation of IMP storage standards – local pharmacy now required to confirm receipt of distribution carton pre-packed with 6 IMP packs, without opening the carton and potentially disrupting the randomisation sequence
6. Stock Control System amended to protect randomisation procedure
7. IMP-related processes revised
Data collection/ database 9. Electronic CRF worked well
10. Database functioned well
8. Verification of IT and database processes
Site staff and recruitment 11. Good engagement
12. Good knowledge of the trial
9. Increased confidence of site investigators
10. Verification of required research infrastructure
11. Confirmation of readiness for rapid activation
  1. ASAP The Adjuvant Steroids in Adults with Pandemic influenza trial, CRF Case Report Form, IMP Investigational Medicinal Product, IT information technology, QC quality control, QP qualified person