On issues concerning carrying out CT of medicinal products in the midst of COVID-19 pandemic
(Russia MOH, Eng translation Source: http://acto-russia.org
). The guidance stresses the need to ensure safety first of patients involved in ongoing trials. It recognizes the need for deviations relating to protocols and monitoring while underlining the need for documentation of deviations and the need to ensure integrity of study data. It outlines specific measures including:
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- Safety of patients and personnel is paramount.
- Use of alternative monitoring methods (visual/remote).
- Expansion of possibilities of home delivery of drugs provided quality and safety standards can be upheld.
- Need for careful documentation and reporting of any deviations necessary to ensure the safety of trial participants to ensure data integrity.