eRAM: Animal Protocol Version 2 (V2) Overview of Changes

What's Different: Key Changes that Researchers can expect

Reduced text entry and fewer number of procedures pages to complete

• Minimized the number of open text boxes throughout the application.
• Much of the form is now populated using dropdown lists (or picklists) and checkboxes, eliminating the need to enter duplicative, and possibly conflicting, information across different protocol sections.
• Default text and pre-populated fields will include programmatic recommendations for common procedures (e.g., aseptic procedure; click “yes” to adhere to what is written, or modify as needed).
• Assurance statements included throughout with a “Yes” or “No” answer choice will require entering the rationale only if responding “No.”
• Increased flexibility to request research-specific plans and dosages (e.g., requesting a “maximum” number of injections instead of having to select specific values).
• Eliminated the Procedure Summary.  Instead, the “Sequential Description of Animal Activities” outlines the procedures to be conducted and details of procedures are entered in the subsequent procedure pages.

Leveraging data entered for other users 

• Names of substances in eRAM now match the names used in Institutional Biosafety Committee Application (IBCA).
• Using the entry of Agents and Substances in specific procedures to create an agent/substance summary table, which lists all agents and substances by procedure (for quick viewing and verification).

Redesigned procedure details

• Procedures are now pages (vs. popups/note pages).
  • An “Other” procedure can be utilized if a procedure does not precisely fit within the predefined list of Procedures.
• If multiple species are included in a single protocol (PRO), then shared procedures are listed only once in the Navigation menu.

Additionally, some "new" expectations are included in sections of V2 that are not in current policies or guidelines.

Version 2 Application

The V2 Protocol Application has five high-level sections, each with applicable sub-sections:

General Information Administrative Information Funding Source(s) Protocol Scope and Relevance Species Species-Specific Animal Information Sequential Description of Activities and Estimation of Animal Numbers     Identification of Pain or Distress     Location(s) of Animal Activities and Transportation between Locations     Environment, Housing, and Management Procedure(s) Procedures Selection procedure pages (as applicable) Compliance Agent/Substance Summary Related Compliance Approvals (as applicable) Personnel

What's the Same

• Protocol Applications have a naming convention of Animal Protocol - PRO00001234. 
• You can navigate through the application in the same way you would as navigating the primary (V1) application. 
  • A Navigation menu displays a list of all the pages in an application. 
    • The entire left navigator can be toggled on or off, (closed << or opened >> ) with the double-arrow icon.
    • The page that you are currently viewing is in bold and highlighted.
      
    • Buttons to exit Exit,  save Save, ​and Continue right arrow (or Finish) "float" at the bottom of the page.
      ​Tip Remember to scroll all the way down to answer additional questions.

• check Validate runs project validation and shows Error/Warning Messages. Pages/questions with green checkmarks checkmark indicate verification/completion; red circles minue indicate incompletion or warnings. 
  • See the Validate job aid for more details.
• compare Compare to view changes between application versions and pages, once more than one version has been submitted. 
  • See the Compare job aid for more details.
• left Go to Navigation shifts the focus from the smartform to the navigation menu, i.e., it opens the navigation menu if it was collapsed.​ 
• comment Reviewer Notes and comment Reviewer notes legend are located at the top-right corner of the application.
  Note Reviewer notes only appear on animal protocols after reviewer notes/questions have been added.
• When entering information for some questions that have Add, Update, or (browse)... buttons, additional fields to complete will open from the right side of the application. For example, when clicking Add to input details, another screen overlaps (similar to a pop-up box).
  Dialog Box Example
  
  • Notes The dialog box can be minimize minimized or close closed to return to the main smartform, but you must click OK to save your selection.
    • The main smartform controls remain locked for editing until you close the slide-in dialog box.
    • If you have minimized a dialog box and returned focus to the main smartform, then options to close Close and restore Restore dialog boxes display in a bar on the right-side of the application.
       
• All questions that display are required. Depending on the response to the question, subsequent questions and related sections may display. These questions and sections provide the ACUO and other associated compliance offices with the detail about the research and precautions needed.
  • Tip Click Continue to advance to the next required page in the application.
• Home workspaces and protocol workspaces remain unchanged.
• Protocols can be submitted from the Protocol workspace using the Submit Application activity.
• The IACUC review process remains unchanged.

Important Information about V1 and V2 protocols

• Approved Version 1 protocols will remain in V1 until they expire, per their 3 year approval.
• Upon completion of the V2 Pilot phase (approximately in spring 2023), the ability to copy old V1 protocols will be turned off.
• Upon completion of the V2 Pilot phase, protocols can be renewed with a V2 application, but minimal information will automatically be copied over into the Renewal application. Therefore, the new V2 protocol will need to be filled out. 
• Currently, only those pilot participants with the ACUO RCA Role will have the Create A New V2 Application button. 
• Upon conclusion of the pilot, the Create New Application button will create V2 protocols instead of old V1 protocols.

Additional Resources

For a list of step-by-step instructions, refer to the Version 2 Protocol Reference Materials.