Ideate Quickstart Guide: IACUC Module

Ideate Quickstart Guide: IACUC Module Ideate is a user-friendly, web-based system for research administration. Most of its functions are intuitive. This quickstart guide does not give click-by-click instructions. Instead, it tells you where Ideate fits into your business process, how to get started, and what points to pay special attention to while using Ideate. Contents Ideate basics... 1 How to access Ideate... 1 Studies and cases... 1 Navigation tips... 1 Home Page, To Do List, Live List... 1 Finishing an item on the To Do List... 2 Finding a protocol or a related item... 2 Navigating inside a submission... 2 Saving and resuming your work... 3 Pick Lists... 3 For a protocol that originated in InfoEd... 4 Work with IACUC to migrate your existing protocols!... 4 After IACUC notifies you that your protocol has been migrated... 4 If you want to complete the shell record yourself... 5 Find your shell record... 6 Complete the shell record, by creating the amendment that completes the shell record and unlocks it for future submissions... 6 Create the progress report, amendment, continuation, or final report... 10 Creating a new lab animal protocol... 11 Create a new study... 11 Complete the main protocol and add the species-specific animal protocol(s) to the study 14 Responding to a modification requested... 20

Ideate basics Before we talk about how to perform specific actions in Ideate, we should go over a few basics of how Ideate behaves. How to access Ideate URL: http://ideate.mssm.edu Username and password: Use your email address as your username and your network password. Use only the Firefox browser to work with Ideate. Do not use Internet Explorer, Safari, or Chrome. Studies and cases In Ideate, a study is a research study. It contains all of the protocols, progress reports, amendments, continuations, and final reports that were ever submitted for that study. So, a study is a container for all of the documents and forms about a research study. A case is an individual protocol, progress report, amendment, final report, or safety form. A case is examined individually, by the appropriate committee. For example, a protocol is examined by the IACUC. A radiation safety form is examined by the Radiation Safety Committee. Each of these items is a separate case. A submission is a collection of one or more cases that are submitted together. For example, suppose you submit a new study in Ideate that contains a protocol and a biosafety form. After the submission is accepted by the IACUC, the protocol becomes a separate case and is examined by the IACUC. The biosafety form becomes another separate case and is examined by the Biosafety Committee. Navigation tips Home Page, To Do List, Live List Your Ideate home page is divided into two parts, the To Do List and the Live List. The To Do List contains actions that you should complete next. The Live List contains all of the the studies and cases to which you have access. When you begin a new submission in Ideate (when you create a new protocol, progress report, amendment, continuation, or final report), it appears in your To Do List. If you save it while in progress, when you return to your home page that submission will be on your To Do List. After you submit it, it is removed from the To Do List. If you want to find a submission that has been submitted, it will be on your Live List. Revised 6/29/2013 1

Finishing an item on the To Do List To resume work on an item that is on your To Do List, just click its link to open the item: Finding a protocol or a related item To find a protocol or one of its submissions in your Live List, from the Subject drop-down menu, select Cases. This lists just your active protocols: All of the protocols, continuations, amendments, and forms that you have access to will be listed. Navigating inside a submission When you are creating a submission, you could have a protocol and various forms inside the submission. There are two navigation features. First, the Navigate to: menu takes you to the cases that are part of this submission. In the example below, the user is in the main protocol, and is about to navigate to the species-specific protocol for that study: The main protocol, species-specific protocol, and biosafety form are all cases that are getting submitted with this submission. Second, the tabs and subtabs are used to navigate within a case. In the example below, the user is in the species-specific protocol for the naked mouse. The user is looking at the Research Design > General Revised 6/29/2013 2

subtab, and is about to navigate to the Research Design > Biosafety subtab: Saving and resuming your work You will see a Save button in the upper left corner. You can click to save your work at any time. Also, whenever you navigate away from a tab or subtab, Ideate saves your work for you. If you stop during the process, when you log back in and reopen the submission it picks up on the same page you stopped at. If you try to submit a protocol, and you haven t completed all the forms, you will receive an error message telling you that have not completed all required fields. The system will indicate in red any tabs and subtabs that are incomplete. Pick Lists In Ideate, you will need to select items from lists. For example, you will select personnel and species from lists that Ideate presents to you. In the example below, the user is selecting personnel from a pick Revised 6/29/2013 3

list: If an item is missing from a pick list the person or species or location is not there let the Ideate support team know immediately so that they can add it to the list. For a protocol that originated in InfoEd You might need to create a progress report, amendment, continuation, or final report for a protocol that you originally submitted using InfoEd. Work with IACUC to migrate your existing protocols! Your protocols that were submitted using InfoEd have been brought over to Ideate. This means that each of your existing protocols has a record in Ideate. However, these are shell records, which means that they have only very basic information, such as the title, PI, species, and approval dates. When you create a progress report, amendment, continuation, or final report, you will use the migrated record in Ideate as your starting point. Gradually, the IACUC office is migrating the complete data from InfoEd. That is, they are filling in these shell records for you. Protocols that have submissions due are being filled in first. When the IACUC office has migrated all of the information from InfoEd into a shell record, they will notify you. You can then use that completed protocol as the starting point for submitting a progress report, amendment, continuation, or final report. After IACUC notifies you that your protocol has been migrated After you receive the email from IACUC telling you that your protocol has been migrated to Ideate, you should log in and examine the protocol to ensure it is complete and correct. 1. Log in to Ideate at http://ideate.mssm.edu, using your email address as your username and your password given above. This will put you at your Ideate home page. Revised 6/29/2013 4

2. On the right side of the page, you will see your Live List. From the Subject drop-down menu, select Cases. 3. Your protocols will be displayed in the live list. Click the name of the protocol that IACUC migrated for you. 4. Your protocol will display: 5. Notice that the Navigate to: menu is set to Main Protocol. Drop down the Navigate to: menu, and you will see the species and any safety forms that the protocol contains: 6. For the Main Protocol and each of the forms under the Navigate to: menu, and go through all of the tabs available under them. 7. If you see any errors, reply to the email sent by the IACUC office with the errors. If you want to complete the shell record yourself As stated above, the IACUC office is filling in the shell records for you. However, if you want to fill in the shell records yourself, you can do that. You might do this if you want to start the process of creating a progress report, amendment, continuation, or final report, very early. When you create a progress report, amendment, continuation, or final report, it is a 3-part process: Revised 6/29/2013 5

1. Find your protocol s shell record in Ideate. 2. Complete the shell record, by creating an amendment and then copying and pasting information from the InfoEd protocol into the amendment. Submit this to IACUC and they will quickly approve it. 3. Create the progress report, amendment, continuation, or final report; using the approved Ideate record as your starting point. Each of these parts is covered in its own section below. Find your shell record Only the PI should do this part of the process. 1. Log into Ideate. Immediately, you will see your Ideate home page. 2. From the Subject drop-down menu, select Cases. This lists just your active protocols: 3. To see if a protocol is active, look in the columns for Approval Start Date and Approval End Date. 4. Click the ID Number of the protocol to open it. After it opens, examine the details to ensure that this is the protocol you want. If the shell record is in Ideate, you are ready to create the amendment that will complete and unlock the shell record for future use. If the shell record isn t there, contact support immediately. Complete the shell record, by creating the amendment that completes the shell record and unlocks it for future submissions Only the PI should do this part of the process. 1. From the Actions drop-down list, select Create Amendment. Then click the Go button: Revised 6/29/2013 6

2. Ideate displays a confirmation message asking if you really want to create an amendment. Click the OK button. Ideate will then create a new, blank amendment. You start at the Amendment Summary tab: 3. In the Amendment Summary field, enter the purpose for this submission. We recommend that you indicate that this is to complete the shell record for a protocol that was brought over from InfoEd, so that you can submit a progress report, amendment, continuation, or final report: Normally, at this point you would move from tab to tab to complete your submission. However, we need to make a quick detour to open the original protocol that was in InfoEd. We do this so that we can copy from that original protocol, and paste into Ideate. 4. Select the Attachments tab. 5. In the Attachments tab, you will see a PDF file that contains a printout of your original protocol. This is the protocol that was submitted in InfoEd. Right-click on the PDF file and open it in another window. Revised 6/29/2013 7

6. Position the window with your original protocol, next to the window that has Ideate open. Now you should be able to see the Ideate record, and your PDF document that was brought over from InfoEd: 7. In Ideate, select the Summary tab. As shown in the above screenshot, you can begin to copy information from the original protocol, and paste it into the relevant fields in Ideate. 8. Complete the Summary tab by copying and pasting from the original protocol, and by making the correct selections for the drop-down fields and radio buttons. 9. Select the Personnel tab. If you re missing any personnel, add them here. If the personnel that you are looking for are missing from the personnel pick list, let the support team know immediately so that we can add them to the list for you. 10. Complete the Personnel tab. Make sure what you have here matches what is in your original InfoEd protocol. 11. Select the Species tab. 12. Add the species that you are using. You can add more than one. After you add a species, you might notice that it has been added to the Navigate to: drop-down menu. That is the species-specific protocol. For each species that you add here, a species-specific protocol gets added to the study. For example, if you added the species Naked Mouse to your study, your Navigate to: menu might look like this: Revised 6/29/2013 8

13. Complete the Species tab. Make sure what you have here matches what is in your original InfoEd protocol. 14. Select the Attachments tab. 15. Under the Attachments tab, upload any support materials that you uploaded into your original InfoEd submission. The attachments are not part of the PDF document that you are looking at. If you uploaded any support material into your original protocol in InfoEd, you will need to open the protocol in InfoEd, download those attachments, and then upload them into the Ideate submission. 16. Make sure what you have in the Attachments tab matches what is in your original InfoEd protocol. At this point, it s tempting to just go to the Submit tab and submit the protocol. But you re not done yet! If you look at the Navigate to: drop-down list, you will see that you have at least one species-specific protocol to complete. 17. From the Navigate to: drop-down menu, select the species-specific protocol for your study: 18. Complete all of the tabs and subtabs in the species-specific protocol. Some of the answers that you choose on the protocol might cause the system to create additional tabs. The system is designed so that if you complete the tabs and subtabs left-toright, clicking the Next link after you complete each tab/subtab, you will go through all of the required tabs in the case that you are working on. Revised 6/29/2013 9

19. When you have finished all of the tabs and subtabs in the species-specific protocol, check the Navigate to: drop-down list for any safety forms that were added to the submission: 20. If needed, navigate to the safety form(s) and complete them. 21. After you have completed all of the species-specific protocols and safety forms, navigate back to the main protocol. 22. Select the Submit tab. 23. Submit the protocol. After submitting the protocol, you might notice that it has disappeared from your To Do List. However, you can still find it in your Live List. At any time, you can return to your Live List and see that status of the submission. Remember, the submission consists of several cases: the main protocol, the species-specific protocol(s), and any safety form(s) that were added. After the submission is accepted by the IACUC, these will all become separate cases and appear as separate cases on your Live List. This amendment was created for the purpose of getting your complete protocol into Ideate. IACUC is aware that they need to approve this submission before you can create the progress report, continuation, amendment, or final report that you need to submit. Therefore, they will expedite the review of this submission. Create the progress report, amendment, continuation, or final report After IACUC approves the completed record that you created, they will send you an email to let you know. This essentially means that your protocol in Ideate now matches the protocol in InfoEd. Now, you are ready to create your progress report, amendment, continuation, or final report. This part can be done by the PI, or by any of the personnel whom the PI gave signature authority to the protocol. In the example below, notice that even though Don Verteramo is the PI he has given Signature Authority to William Rice. That means either Verteramo or Rice can create a submission for Revised 6/29/2013 10

this study: 1. Log in to Ideate, and on your home page, from the Subject drop-down menu, select Cases. This lists just your active protocols. 2. Search for the protocol that the IACUC just approved. They should have told you the ID Number of the protocol. You can also search by study title. 3. Click to open the protocol. Then, check the Navigate to: menu to ensure that you are at the Main Protocol. 4. From the Actions drop-down menu, select the action that you want to perform. You are here to create a progress report, amendment, continuation, or final report for this protocol: 5. After you select the action, Ideate will create the case and display the first tab that you need to complete. 6. Complete the tabs and subtabs (all of the cases) in the submission. 7. Have the PI submit the completed application. Once again, this is done by navigating to the main protocol, and selecting the Submit tab. Creating a new lab animal protocol This process is for creating a new, initial application, of an IACUC protocol. Recall that in Ideate, a study is a collection of related cases that have been submitted to the relevant committees. When you submit a new lab animal protocol, you will: 1. Create a new study. 2. Complete the main protocol and add the species-specific animal protocol(s) to the study. 3. Complete any safety forms that were added to the study. 4. Submit the package to the IACUC. Create a new study 1. Log in to Ideate. 2. From the top of your home page, select Create New and then Study. Revised 6/29/2013 11

3. Ideate immediately displays a Master Form: The Master Form consists of basic information about your study. It does not contain the speciesspecific protocol, safety forms, or other detailed forms. 4. Complete the Questionnaire tab. For an IACUC protocol, you will just select the Animals button and then click the Next link. 5. Complete the Summary tab. Ideate assumes that the person creating the study is the principal investigator. If you are creating it for someone else, replace your name with the name of the principal investigator. Revised 6/29/2013 12

Ideate also picks up the user's primary department. If needed, change this to the correct department for the PI. 6. Complete the Personnel tab. You can see that Ideate has already added the logged-in user and the PI as personnel on this study. Also, the user who created the study for the PI (William Rice) is granted access to it by default. Assign a Role to each person in the study, and check that all the Contact Details are complete and correct. 7. Select the Create Study tab. Click the agreement, and then click the Create Study button: Revised 6/29/2013 13

8. After the study is created, you are returned to your home page. Looking under your to-do- list, you can see your study is listed there, with a link that says, Complete the initial application: 9. In the next section, You will click that link, complete the main protocol, and add the species-specific protocol(s) to your initial application. Complete the main protocol and add the species-specific animal protocol(s) to the study After you created the study, a new task was added to your todo list. It is named with your study title, and the temporary IACUC number, and has a link reading Complete the initial application submission. Revised 6/29/2013 14

1. Click the link Complete the initial application submission. Ideate displays Main Protocol for the study. You ll know you are looking at the main protocol when you check the Navigate to: drop-down menu: 2. At the bottom of the page, you will enter a lay summary for the study. You might have written your protocol in your favorite word processor. If so, you can just copy and paste the text into Ideate. On a PC, try the keyboard shortcut Control-V to paste, and on a Mac, try Command-V. Revised 6/29/2013 15

Some of the questions that you answer will result in additional fields being displayed. For example, if you indicate that funding is external, later in the process you will be required to indicate the name of the funding agency. 3. Complete the Summary tab, and then select the Personnel tab. In the screenshot below, you can see that these are the personnel that were added when the study was created. Notice that the person who created the study, William Rice, and the PI, Don Verteramo, cannot be removed. However, the other person listed, William Fultz, can be removed. Also notice that the person who created the study and the PI automatically have access to it in Ideate. 4. Add and remove personnel as needed. Notice that there is a Research Personnel and an Other Personnel subtab. Make sure you put each person under the correct subtab, and that each person is associated with the correct department and has the correct role. 5. After you complete the Personnel tab, select the Species tab. Revised 6/29/2013 16

6. Use the Add button to add all of the species that you will use in this study. When you click the button, Ideate will give you a list of species from which to choose. If the species you need is not on the list, contact support immediately and we will add it to the list for you. 7. After you complete the Species tab, if there is a Funding tab, select it. 8. Begin the process of adding a funding source by clicking the Add New Funding Source button. Revised 6/29/2013 17

9. For each funding source that you add, you will specify several pieces of information: If you have been given a GCO Number for the funding source, enter it. If not, you can leave this field blank. Upload copies of the grant and protocol, if they apply to this funding source. The uploads can be in any format. When you specify the Funding Source, you will choose from a pick list. If the funding source is not on that list, contact the support team immediately and we will add it for you. 10. After you complete the Funding tab, select the Attachments tab. 11. Any documents that you uploaded are already here in the Attachments tab. In this example, the user uploaded the grant contract and animal protocol, so they are listed here: 12. To upload additional supporting documents, begin by clicking the Add button. While uploading, give the file a descriptive name in the Name field. 13. After you complete the Attachments tab, do not select the Submit tab. You still have a species-specific protocol to complete, and possibly a safety form(s). Revised 6/29/2013 18

14. From the Navigate to: drop-down menu, select the species-specific protocol for your study. 15. Complete all of the tabs and subtabs in the species-specific protocol. Some of the answers that you choose on the protocol might cause the system to create additional tabs. The system is designed so that if you complete the tabs and subtabs left-toright, clicking the Next link after you complete each tab/subtab, you will go through all of the required tabs in the case that you are working on. 16. When you have finished all of the tabs and subtabs in the species-specific protocol, check the Navigate to: drop-down list for any safety forms that were added to the submission: 17. If needed, navigate to the safety form(s) and complete them. 18. After you have completed all of the species-specific protocols and safety forms, navigate back to the main protocol. 19. Select the Submit tab. 20. Submit the protocol. If you are not the PI, then submitting the application will not send it to the IACUC. Instead, it will send it to the PI. The application will appear on the PI s To Do List. When the PI opens the application from the To Do List, the PI will need to review and submit the protocol: After submitting the protocol, you might notice that it has disappeared from your To Do List. However, you can still find it in your Live List. Revised 6/29/2013 19

At any time, you can return to your Live List and see that status of the submission. Remember, the submission consists of several cases: the main protocol, the species-specific protocol(s), and any safety form(s) that were added. After the submission is accepted by the IACUC, these will all become separate cases and appear as separate cases on your Live List. Responding to a modification requested Your application might be returned to you with a request to modify it. If that happens, you will be notified two ways. First, you will get an email from the IACUC telling you that the application needs to be revised. Second, a task appears in your todo list: Click the to do item. The protocol opens and you see the same view as when you were creating it. Additionally, on the left is a column with comments from the reviewer. The entire application is editable. Make your edits. In the left column you can enter comments about your edits if you want. When you finish making your revisions, submit the protocol. If you want specific instructions on how to navigate through the protocol and fill out specific tabs, refer to the instructions under Creating a new lab animal protocol. Revised 6/29/2013 20