Precision to the last detail

COVID-19 Regulatory Guidelines Review

Global Health Authorities have introduced guidelines for clinical trials due to COVID-19. GXP Engaged invite you to access our review of approx. 60 of these guidelines covering aspects affected by the pandemic such as the provision of IMP/Supplies to subjects, Subject Visits, Informed Consent, Monitoring & Remote SDV, Sponsor Risk Assessments, Protocol Deviations & Amendments, Safety Reporting etc.

We warmly welcome feedback, additions, updates, suggestions for improvement in our review/interpretation.

GXP Engaged would like to add the disclaimer that the information on the spreadsheet is provided according to our review and interpretation of the guidance documents. Some documents do not give clear guidance and some text is open to interpretation. We discourage the taking of any specific action solely on the basis of the results presented. The original guidance document should always be consulted, or clarification sought from the relevant authority.

Regulatory Guidance Assessment (65kb)
Update 17 Apr 2020