Expedited Protocol Action Required
If your study was originally approved as Expedited, and IS NOT classified as FDA Expedited Category 1, and FALLS UNDER federal OHRP regulations 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.
|
|
Was initially approved BEFORE Jan 21, 2019 |
Resubmit your study as a new, initial protocol no later than Feb 1, 2022. It will receive approval for 5 years. There is no requirement for continuing review during this 5-year approval period. |
|
Was initially approved BEFORE Jan 21, 2019 |
Resubmit your study as a new, initial protocol no later than Feb 1, 2022. It will receive approval for 5 years. There is no requirement for continuing review during this 5-year approval period. |
|
Was initially approved ON/AFTER Jan 21, 2019 |
If your study was approved ON Jan 21, 2019 or AFTER, you do not need to take action at this time. Your study will be automatically updated in the system to reflect a 5-year approval period. This 5-year period will begin with your study’s initial approval date. There is no requirement for continuing review during this 5-year period. However, you will still be expected to comply with all other reporting requirements such as Amendments and Event reporting. |