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 Outdated documents identified 5.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 |