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**Obtain informed consent prior to VIGIL initiation**Expanded Access IND Protocol: Use of Vaccine Immune Globulin Intravenous (VIGIL, CNJ016) for Treatment of Human Orthopoxvirus Infection in Adults
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How to fill out expanded access ind protocol
How to fill out expanded access ind protocol
01
Identify the patient who is in need of treatment that is not available through other means.
02
Obtain approval from the FDA for the use of the investigational drug or device.
03
Compile all necessary information and documentation to fill out the Expanded Access IND Protocol form.
04
Submit the completed form to the FDA for review and approval.
05
Once approved, follow the protocol outlined in the form for administering the investigational treatment.
Who needs expanded access ind protocol?
01
Patients who have exhausted all other treatment options and are in urgent need of access to investigational drugs or devices.
02
Patients who are not eligible to participate in clinical trials but could still benefit from experimental treatments.
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What is expanded access ind protocol?
Expanded Access IND Protocol is a FDA-regulated process that allows patients with serious or life-threatening conditions to gain access to investigational drugs outside of clinical trials.
Who is required to file expanded access ind protocol?
The sponsor of the investigational drug is required to file the Expanded Access IND Protocol.
How to fill out expanded access ind protocol?
The sponsor must submit a complete application to the FDA including the investigational drug information, patient eligibility criteria, and informed consent documentation.
What is the purpose of expanded access ind protocol?
The purpose of Expanded Access IND Protocol is to provide access to investigational drugs to patients who are not eligible for clinical trials but have serious or life-threatening conditions.
What information must be reported on expanded access ind protocol?
The Expanded Access IND Protocol must include information on the investigational drug, patient eligibility criteria, treatment plan, monitoring procedures, and adverse event reporting.
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