eRAM: Controlled Substance Registration (CSR)

Overview

Research involving the use of controlled substances at the University of Michigan is strictly regulated. U-M faculty who obtain, store, and utilize controlled substances in their research must obtain, as applicable, a State of Michigan license and a U.S. Department of Justice – Drug Enforcement Administration registration AND record your approved license/registration (CSR) in eRAM.

When an animal protocol lists controlled substances being used for research, at least one Controlled Substance Registrant must be included on the protocol. Unless the Registrant is given edit rights on the protocol (this is done on the Personnel page of the protocol), they will only have the ability to edit the Controlled Substance Registration (CSR).

Create CSR

1. Verify Controlled Substance Registrant is selected under My Roles.
   
2. Click Create CSR.
3. Complete all fields listed on the form.
   Note If the Actual Storage Address is the same as the Registration Address, use the Copy or Recopy Actual Storage Address to Registration Address button to automatically copy the address information to the bottom section of the form.
4. Click OK.
   The CSR workspace displays.

Edit CSR

Several activities in the CSR workspace can be used to edit information in the CSR as needed. Only the Registrant and any individuals listed on the CSR as an Authorized Designee can edit the CSR. CSRs for which you have edit rights can be accessed via the CSR tab in your Controlled Substance Registrant workspace (remember to select Controlled Substance Registrant from My Roles).

Use the following Activities as needed:

• Update CSR Information – Update the information entered on the CSR (Michigan License Expiration Date, Registration Expiration Date, Storage Address, etc.).
• Add Comments – Add comments visible to Controlled Substance Monitors and CSR Authorized Designees.
• Maintain Substances – Add substances that are not already on an Animal or Human Protocol related to the CSR.
• Maintain Personnel – Add Authorized Designees (people who can edit the CSR) and Authorized Personnel (people who will work with the substances listed on the CSR, but cannot edit the CSR).
• Upload State of Michigan Inventory Documents – Click Add to upload a copy of your state annual inventory form. A reminder email notification will be sent to the Registrant annually when the submission period has begun.

Select CSR for a Protocol

Upon submitting a protocol, submitting changes to a protocol via an amendment and/or when a protocol is approved, if the set of controlled substances listed on the protocol contains any substances not covered by a correctly associated CSR, the PI and application/protocol editors receive an email notification reminding them to execute the protocol activity, Maintain Protocol Controlled Substances.

1. Click the link in the email notification to open the protocol workspace.
2. From the Activities menu, click Maintain Protocol Controlled Substances.
3. Click Update next to an individual substance listed and select the applicable CSR to be assigned to the substance.
   Notes
   • The substance listed in the activity window does not have a CSR associated with it.
   • When clicking Update, only CSRs associated with people listed on the protocol will display.

   

4. Click OK.