If your study was originally approved as Expedited, and IS classified as FDA Expedited Category 1, take the required action described below:
| If your study… | Action Required |
| Will close BY March 31, 2022 |
No further action is required unless your study requires continuing review between now and Mar 31, 2022. However, if your study is not closed by Mar 31, 2022 and you have not submitted a new study for review and approval, it will be closed in the system unless you have been granted an exclusion. |
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Will be 5 years old BY Mar 31, 2022 |
Resubmit your study as a new, initial protocol no later than Feb 1, 2022. After your new study’s approval, you will still be required to submit a request for continuing review annually to comply with FDA regulations. |
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Will NOT be 5 years old BY Mar 31, 2022 |
You do not need to take any action currently. However, when your study is 5 years old, you will need to resubmit it as a new, initial protocol. After your new study’s approval, you will still be required to submit a request for continuing review annually to comply with FDA regulations. |
