Please, read this guidance
, agreed by the Clinical Trials Expert Group (CTEG) of the European Commission supported by the EMA, the Clinical Trials Facilitation and Coordination Group (CTFG) of the Heads of Medicines Agencies (HMA) and the GCP Inspectors’ Working Group coordinated by the EMA.
Very interesting topics for patient advocates as additional clarification on obtaining informed consent, the link to methodological guidance on statistical considerations in relation to COVID-19 pandemic, advice on IMP stocks, safety reporting, the conduct of audits and temporary halts as well are included in this document.
This is Version 2 (27th March 2020)
but due to the rapidly evolving situation, further updates to this guidance are possible and likely.