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APB Related Questions

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How do I resubmit a returned protocol?

How do I renew a protocol? or how do I submit a Continuing Review?

How do I submit a clinical report (SAE, AE)?

How do I close a protocol?

When should a protocol be submitted for review?

When will my protocol be reviewed?

For how long is a protocol approved?

How do I resubmit a returned protocol?

If a protocol is returned, click on the protocol number under Action Items (or "Resubmit for review") to open the protocol. Click on "BSP Return Notes" and make the requested changes to the protocol. Once the changes are made, click "Submit Protocol" to resubmit the protocol for review.

How do I renew a protocol? or How do I submit a Continuing Review?

To renew a protocol, choose "Start Renewal" from the "More Actions" drop down menu in the left hand column. Once the renewal page is opened, select the radio button for renew with no changes or renew with changes. You will only be able to edit the protocol if you select "Renew with changes". Once you are ready to have the protocol reviewed, make sure to click the submit protocol button to submit the renewal for review.

How do I submit a Clinical report (SAE, AE)?

To submit a report for a clinical APB protocol choose "Attach Reports" from the "More Actions" drop down menu in the left hand column. Attach the documents and click "Submit Report" to send the report to the APB for review.

How do I close a protocol?

To close a protocol, choose "Close Protocol" from the "More Actions" drop down menu in the left hand column. (Remember: this action cannot be undone.) Once the protocol is closed, it will be listed under “Inactive Protocols.”

When should a protocol be submitted for review?

Protocols are required by the 1st of the month, for review at that month’s meeting.

When will my protocol be reviewed?

APB meetings are held once a month. In general, protocols submitted before the first of the month will be reviewed and considered at that month's meeting. See the schedule for submission deadlines and meeting dates.

For how long is a protocol approved?

BSL2 and 2+ are approved for three years, and require annual renewals. BL3 are approved for ONLY one year.