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TIP Sheet SPONSORINVESTIGATOR WITHDRAWAL OF IND Tip #1: What do I need to consider? The FDA allows a sponsor investigator to withdraw an IND without prejudice, in other words, they won't hold it against
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What is ind withdrawal - gcrc?
The ind withdrawal - gcrc is a form used to officially withdraw an individual from a clinical research study at a General Clinical Research Center (GCRC).
Who is required to file ind withdrawal - gcrc?
The individual participating in the clinical research study at a GCRC or their legal guardian is required to file the ind withdrawal - gcrc.
How to fill out ind withdrawal - gcrc?
To fill out the ind withdrawal - gcrc, the individual or legal guardian must provide their personal information, study details, reasons for withdrawal, and any additional required information.
What is the purpose of ind withdrawal - gcrc?
The purpose of the ind withdrawal - gcrc is to formally document the withdrawal of an individual from a clinical research study at a GCRC.
What information must be reported on ind withdrawal - gcrc?
The ind withdrawal - gcrc must include the individual's personal information, study details, reasons for withdrawal, and any additional required information as specified by the GCRC.
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