Who Needs to Submit a Protocol?

OEHS requires that all Wayne State University Principal Investigators (PIs) who possess a State of Michigan License and DEA registration for the use of Controlled Substances (CS) in research (in vitro and in vivo) to complete and submit a CS protocol via the eProtocol platform. If you are unsure if this applies to your use of CS at WSU, please contact Diane Gilbert at dgilbert@wayne.edu or 313-577-9507.

Accessing eProtocol:

Please note the following when using eProtocol for the first time:

• Use Firefox 12 and higher or Apple Safari for optimal use of eProtocol
• Pop-up blocker must be disabled when using eProtocol
• Pop-up windows may appear beneath other open applications use the task bar to locate open pop-up windows

Additional information about the eProtocol platform can found on the Division of Research eProtocol website.

How to Prepare and Submit a CS Protocol:

The video below provides a description of how to prepare and submit a CS Protocol in the eProtocol platform. If you require any assistance in the preparation of your protocol, please contact Diane Gilbert at dgilbert@wayne.edu or 313-577-9507.

Protocol Maintenance:

Once a protocol has been approved, it is the responsibility of the PI to maintain the protocol. This includes re-submission of the protocol for annual review. When submitting a continuing review, please ensure the following sections have been updated:

• Changes in personnel
• Updated State of Michigan License
• Updated DEA registration

Failure to resubmit the protocol for annual review will result in the protocol expiring and a new protocol will need to be prepared and submitted.

In addition, PIs must ensure that approved protocols remain accurate between review periods. Therefore, amendments to an approved protocol must be made when there is a change in:

• Personnel
• Storage locations
• Type of CS being used

IACUC Requirements:

PIs using CS in animal research must provide a CS protocol number in the "Are you using?" section of their IACUC protocols. In order to use CS in animal research, a PI must either be a CS License Holder, and maintain their own CS Protocol, OR, be listed as a "Controlled Substance: Allowed Investigator" on an approved CS Protocol (if working under someone else's CS license and registration). When completed correctly, the PI will be able to choose the appropriate CS Protocol number from a drop down list in the IACUC application.

Please contact Diane Gilbert at dgilbert@wayne.edu or 313-577-9507 if you have any questions regarding the integration of IACUC and CS protocols.