Submitting Your Protocol
Upon completion of your protocol the following actions are available in the right hand menu:
The option to View Admin Notes & Files is available. If you have been working with your Compliance officer while developing your Protocol there may be the notes and attachments in this section that the Admin would like you to review. In most cases this section will be empty until the Protocol has been submitted for review.
As the initiator you can Abandon this Protocol until it is submitted for review if you decide not to proceed with this document.
You can submit for review using the appropriate 'Submit' action button on the right-hand corner.
There is a 'Print' option available that allows you to print the entirety of your protocol to PDF for your review or for physical printout of you desire.
After you click the 'Submit' button the protocol will be sent to the appropriate protocol administrator for review. You will not have the following Actions available in the right hand menu of the protocol:
Gives you a overview of all the Action Items added to a protocol that can be viewed by the researcher.
The View Admin Attachments will always be available for the life of the protocol; these are attachments added by administrators.
You will now have an action button of 'Withdraw' available which allows you to pull back the protocol from review if you need to make additional edits prior to review. Once the protocol administrator assigns your protocol to a committee the 'Withdraw' action is no longer available.
The 'Print' option will always be available for the life of the protocol.
After submission you can track the progress of your protocol in the researcher portal which will display the current Status, Assignment, Assigned Reviewers, Approval Date, Expiration Date, etc.
The columns displayed are configurable via the Manage Columns option in the top header and you can narrow down results with Advanced Filters or already Saved Filters.
Returned Protocols Requiring Action
Upon review of a given protocol the administrator may send it back to the PI for additional information or other requested changes. When a protocol is returned the status of the protocol will either be Returned to PI or Requires Revision in your researcher portal. Protocols are returned to PI when they are incomplete or not ready for review and protocols that require revision have been reviewed but need some sort of edit or additional information prior to approval.
Upon opening the protocol you will see either general action items or field specific action items highlighted with indicators.
Upon clicking the 'Action Items' icons the right sidebar will open where you can reply to the comment. Within you can edit the necessary items and add a comment back.
The Show Latest Changes checkbox allows you to see any changes that have occurred on the protocol since the last version. This helps better identify items that have changed since the last submission.
Review Prior History or Activity
Also, when a protocol is returned the top section provides a history of the versions and a summary of the current protocol status and information. The 'Version' dropdown allows you to view prior version information if you desire.
The 'Activity Log' in the top header gives you a history of the series of actions that have taken place on this protocol.
Once the Action Items have been addressed and you have applied changes where appropriate you can resubmit the protocol back to the administrator using the 'Resubmit' action button in the right-hand corner. Also, if you decided to cancel or permanently discard this protocol for any reason you can utilize the 'Abandon' action button.