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EXPANDED ACCESS PROTOCOL
and Informed Consent
Intermediate size Patient Population patients with Critical COVID-19 with respiratory
failure who do not quality for Protocol RLF100001Protocol#: RLF100EA1
NCT04453839Copyright
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What is expanded access protocol?
An expanded access protocol is a regulatory process that allows patients with serious or life-threatening conditions to access investigational drugs that have not yet received official approval from regulatory authorities.
Who is required to file expanded access protocol?
Sponsors of the investigational drugs, typically pharmaceutical or biotech companies, are required to file an expanded access protocol.
How to fill out expanded access protocol?
To fill out an expanded access protocol, sponsors must provide detailed information about the drug, the target patient population, the rationale for the request, the treatment plan, and informed consent procedures.
What is the purpose of expanded access protocol?
The purpose of the expanded access protocol is to provide a pathway for patients to receive experimental drugs that may be their last hope for treatment, while ensuring that the process is safe and monitored.
What information must be reported on expanded access protocol?
The information that must be reported includes patient eligibility criteria, the potential risks and benefits of the treatment, informed consent details, and the monitoring plan for adverse events.
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