AO How to Guide 006: How to Backfill a Protocol Shell
How to Guide 006: How to Backfill a Protocol Shell
Introduction
- Purpose of the Guide- The purpose of this guide is to provide step-by-step instructions for one of the two Cayuse transition pathways. Backfilling a protocol involves creating an amendment to an approved Institutional Animal Care and Use Committee (IACUC) protocol shell and 鈥渂ackfilling鈥 the empty sections of the protocol form.
- Scope/Audience- Principal Investigators (PIs), PI Groups.
Getting Started
Step 1: Logging into the
Step 2: Navigating to the Animal Oversight module- While on your Home page, select 鈥淎nimal Oversight鈥 from the 鈥淧roducts鈥 drop-down menu.
Step 1: Locate Your Protocol
To begin, first locate your protocol. Make sure you are on the Protocol Actions tab; this tab will be highlighted in the Animal Oversight Table of contents to the left of your screen.
NOTE: Your protocol number will be different, however the protocol title will be the exact same title as you're approved LEO submission.
Step 2. Start An Amendment
Once you locate your protocol, highlight the row with your cursor and then press 鈥淪tart Amendment鈥 at the top of the page.
Step 3. Amendment Information
The next page will ask for a description of your proposed amendment. Simply explain that you are backfilling the protocol.
Next, press the Amend Protocol button to begin the backfill of information.
Step 4. Welcome to Your Protocol Shell
To the left of your screen, you will see prepopulated sections in the table of contents. These pre-populated sections contain minimal information. The pre-populated sections include options, Protocol, Overview, Use Types, Personnel, Databases Searched, And Endpoints.
We recommend that you focus on these prepopulated sections before you make any additional selections.
For example, if you begin on the Protocol Overview page, click on the tabs at the top of the screen to backfill the required information according to the instructional text at the top of the page. Click on Flay Abstract, Benefits, and Project Summary to provide the necessary information in each subsection.
Step 5. Use Types
Next, confirm that the Research type provided in the drop down menu in the Use Type section is the most accurate selection for your protocol. A description of each use type is located at the top of the page in the provided help text.
NOTE: If your protocol does not fit into any of the more specific categories, select 鈥淩esearch鈥 from the drop-down menu. To advance through the form, press 鈥淣ext Page鈥.
Step 6. Personnel List
In the Personnel List section, you will need to add all members of your study team and backfill some information about yourself.
- To backfill your information as PI, highlight the row where your name appears and then press 鈥淓dit Personnel鈥, please be sure to complete the blank fields, choose your email and notification preference. Next, complete the remaining question on the 鈥淧ersonnel Activities鈥 and 鈥淭raining鈥 subpages. Click on the tab to begin each subsection.
Step 7. Personnel List (Adding New Study Team Personnel)
- To add new personnel, click the 鈥淎dd Personnel鈥 button to begin. Use the search feature in the first field to find the individual in our database and then proceed to select the remaining fields on this page. Next, complete the remaining question on the 鈥淧ersonnel Activities鈥 and 鈥淭raining鈥 subpages. Click on the tab to begin each subsection.
NOTE: Students will not automatically appear in the Cayuse database. Students who will be listed as study personnel for the first time must request access by filling out the Cayuse Individual Account Request form.
Please allow 1-2 business days for account setup. When completed the student will receive a notice from Cayuse, after which they will appear in the "Name" searchable drop-down menu.
Step 8. Endpoints
This section outlines the requirements for defining endpoints and animal disposition in research studies. Researchers must describe how animals will be monitored, including the clinical criteria and frequency for euthanasia, and specify the point at which animals will be removed from the study or euthanized. For animals not euthanized, researchers need to detail their disposition at the end of the study.
In cases of unexpected adverse conditions requiring emergency euthanasia, researchers must agree to either perform the euthanasia themselves or notify the Laboratory Animal Resources (LAR) immediately. If LAR cannot contact the researcher in a timely manner, LAR is authorized to perform the emergency euthanasia according to American Veterinary Medical Association guidelines. This section also asks whether end-of-life anesthesia will be used.
Click on the header of each tab (Endpoints and Animal Disposition) to provide the necessary information.
Step 9. Return to the Options Section
Next, you will need to return to the Options page. To do so, click on the 鈥淥ptions鈥 section in the Table of Contents.
Once you are on the Options page, you will need make selections on this page in order to populate the remaining sections of the form.
Step 10. Options
The Options section protocol form is divided into two key subsections, the Choose Options section and the Protocol Species Grid. The Choose Options section is a series of checkboxes and yes or no questions that may be applicable to your protocol. The Protocol Species Grid will help you identify the 鈥渟pecies鈥 you intend to work with (using common names) as well as the elements that are applicable to your protocol.
Your selections on this page will populate applicable sections of your protocol form. You can return to this section at any time to change your selections.
Table of Contents
Based on your selections on the Options page, your protocol form will populate sections that are specific to your proposed research activity. To the left of your screen, the significant sections of the form are listed in the Table of Contents. You can click on individual sections to move through the form. Once the checkbox near the section title turns green, this means that you have responded to each of the required questions.
NOTE: In some cases, a question may not display as required (denoted by a red Asterix*) due to the smart form logic mechanism, however, the information may still be required by the IACUC.
NOTE: Your protocol number will appear at the top of the page just above the Table of Contents. In the image below the yellow arrow points to the protocol number (00000086 2).
Need Guidance?
If you have any questions about completing a specific section of the form, please refer to our comprehensive How-to-Videos. We provide a detailed video for each section of the protocol form. Once you are ready to submit your protocol, please return to this page to continue from where you left off."
Step 11. How Can I Tell If My Form is Completed?
Once you have completed the remaining sections of the form, the pencil icon will appear next to the section header of each title in the table of contents.
Step 12. How to Submit the Backfilled Amendment
To submit the backfilled amendment, scroll down the table of contents until you see Submit Protocol. Click on 鈥淪ubmit Protocol鈥
Please be sure to read thoroughly over the investigator assurances before pressing 鈥淪ubmit鈥.
Step 13. Monitoring Your Submission鈥檚 Progress
On your animal oversight dashboard, click on 鈥淧rotocols in Review鈥 to see your submitted protocols and amendments. This table updates as the submission moves through the review process.
