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FDA Approval Date

Data Field definition table including the field name, definition, entry instructions and requirements
Field Name Definition Requirement
Entry Instructions		 Responsible for Entry QA
FDA Approval Date The date the FDA officially allows the study to proceed. Recommended
The FDA does not send formal letters of approval. If 30 days have passed since the FDA receipt of the initial submission without FDA correspondence, day 31 is the effective date.
 PC Console edit / Protocol Coordinator Yes

Keywords:
IND IDE 
Doc ID:
101806
Owned by:
Molly H. in SMPH Research Informatics
Created:
2020-05-07
Updated:
2022-12-02
Sites:
SMPH Research Informatics