This guidance document covers the actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority
The Central Drugs Standard Control Organization (CDSCO) acknowledges the potential impact of COVID-19 pandemic on the healthcare system and broader society, and the impact it may have on clinical trials and subjects. The present situation of lockdown across the country may affect approved protocol adherence, regulatory provisions/procedures, trial subjects’ recruitment, laboratory testing, and the supply of investigational products, adverse event reporting, visits, assessments, and many other aspects of clinical trial conduct.
To address the present crisis, CDSCO issued a new notification for conducting clinical trials in India. This guidance covers actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority.
The below guidance will provide further clarity for all parties involved in clinical trials during this time in India.
CDSCO understands the various challenges in the conduct of clinical trials during the COVID-19 pandemic in India and has come up with the new guidance to help conduct clinical trials at this hour of crisis
1. Gazette notification F. No-DCGI/MISC/2020(104), Government of India, Director General of Health Services, Central Drug Standard Control Organization. Dated 30th March, 2020.
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