FDA Approval Date
| 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 |