Clinical Research and GCP Update

59

Did you revise and keep to your monitoring plan?

• The sponsor should consider the extent and nature of monitoring necessary for each trial.̶ What must be done now, what can be done later?̶ Cancelling of on-site monitoring visits and extending of the period between monitoring visit̶

Implementing phone and video visits (without unnecessarily increased burden to the investigator site and taking into account trial participant integrity) ̶ Increased centralised monitoring and central review of data if possible and meaningful̶ Remote SDV is exceptional cases.

59

60

Do you have a post-pandemic plan?

60

© Brookwood Global (Canary Ltd) 2021

30