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Table 2 Reasons why survey responders did or did not conduct a risk assessment prior to developing the monitoring plan

From: Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

Participants who did conduct a risk assessment (n = 50) % Participants who did not conduct a risk assessment (n = 35) %
Facilitators Barriers
To improve patient safety 43 (86%) Question not relevant, developing monitoring plan is a sponsor duty 15 (43%)
To improve data accuracy 32 (64%) It is not a GCP requirement 7 (20%)
To fulfil GCP requirements 29 (58%) Do not have the expertise to perform a risk assessment 6 (17%)
To determine a schedule for on-site monitoring visits 21 (42%) It is too time consuming 6 (17%)
To fulfil HPRA/IMB requirements 20 (40%) It will not improve patient safety 2 (6%)
To reduce monitoring costs 8 (16%) It is too expensive 1 (3%)
  1. GCP Good Clinical Practice, HPRA Health Protection Regulatory Authorities, IMB Irish Medicines Board