New Form Required for Closure of FDA Studies Conducted under an IND or IDE

August 2, 2018

When requesting closure for studies regulated by the U.S. Food and Drug Administration (FDA) and conducted under an IND or IDE, a new form will now be required in addition to the standard closure form. The new form, “HRP-555 – Template - Appendix to the Closure Form for FDA Regulated Studies Conducted Under an IND or IDE” will be required in addition to the “HRP-528 – Template – Closure Report.” The new form includes FDA requirements specific to recordkeeping for studies conducted under an IND or IDE. This form should be uploaded as part of the continuing review closure submission in the Click™ Research Compliance System. This form should also be completed for studies where an external IRB is IRB of record. For external IRB studies, the form should be completed when the study is closed by the external IRB and should be submitted as an update submission in Click. The new form is available at: