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NORTHEAST TEXAS COMMUNITY COLLEGE JOB DESCRIPTION PROGRAM DIRECTOR NURSING Department: Allied Health FLEA Status: Exempt Grade/Level: Admin/Prof Work Schedule: Monday-Thursday: 8AM- 6PM Friday: 8AM
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What is special condition form ind?
The Special Condition Form IND is a form required by the FDA for reporting certain types of deviations from the normal investigational plan or protocol for an investigational drug.
Who is required to file special condition form ind?
Investigators conducting clinical trials or studies involving investigational drugs are required to file the Special Condition Form IND.
How to fill out special condition form ind?
The Special Condition Form IND can be filled out online through the FDA's Electronic Submissions Gateway.
What is the purpose of special condition form ind?
The purpose of the Special Condition Form IND is to notify the FDA of any deviations from the investigational plan or protocol for an investigational drug.
What information must be reported on special condition form ind?
The Special Condition Form IND must include details on the deviation, the reason for the deviation, the impact on the trial, and any steps taken to mitigate the impact.
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