WISER. Wake Integrated Solution for Enterprise Research. Protocol Creation, Activation, and Management. For Non-Oncology Studies.

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1 WISER Wake Integrated Solution for Enterprise Research Protocol Creation, Activation, and Management For Non-Oncology Studies Version 6/11/2018 TRAINING MANUAL

2 WELCOME to WISER! Navigation and Home Page Set-up WISER uses both horizontal and vertical menus. The vertical menu controls the horizontal. Clicking the OnCore logo in the upper left corner of the page returns you to the home page from anywhere in WISER. The main Menu contains all menus and menu items that you have permission to see. The Favorites Bar sits at the top center of the page. It contains menus and menu items that you have selected as frequently visited sites (such as the PC Console). The environment name and the current user are always displayed in the top right corner. The gear icon, located under the user name, opens the Home Screen Configuration page, allowing you to select widgets that provide quick access to your protocols, subjects, saved searches, assigned tasks, recently run reports, or other frequently used tools. On each page of a console you will see a question mark in the upper right hand corner. Selecting this will open a page that describes and defines the components of the page. 2 P a g e

3 WISER Quirks and Idiosyncrasies Google Chrome is the recommended browser for using WISER, although you may also choose to use Safari, Firefox, or Internet Explorer. The browser s Back button is not your friend! It may kick you out of the system. Use the navigation within the system to access a desired site. Disable pop-up blockers for WISER for optimal functionality. Note: To learn more about configuring your home screen and general idiosyncrasies of WISER, please review the associated training documentation on the CTSI website. What is a Protocol? Protocols are the foundation of all WISER functionality and features. Protocol information must be entered before building calendars, creating a protocol budget, enrolling subjects, tracking subject visits, or invoicing sponsors. The PC Console (Protocol Coordinator Console) is used to enter, view and update protocol information. Protocol coordinators track protocol ID numbers, objectives, assigned staff, sponsors, participating institutions, regulatory information, investigational drug and device information, and other details of each research study. 3 P a g e

4 Create a New Protocol Log in to WISER using your Medical Center ID and Password. The first time you log in, the Home Screen will consist of an Announcement section only. Navigation: Protocols > PC Console > New Protocol The Protocol Details template opens with the Protocol No. pre-populated. 1. Enter the data for your study. Remember to click the question mark for an explanation of the page and the requested data, if needed. 4 P a g e

5 2. Once you have addressed the 5 required fields (marked with an asterisk), you may select Submit to enter an initial save of the Protocol. This triggers a full menu, allowing you to continue entering the WFBMC required data. Selecting Close for a page makes it view-only. Further changes to any of the tabs in the protocol will require you to select the Update button, and then click Submit to save your update(s) before navigating out of the page. Note! If you enter new data and fail to click Submit before navigating to another page in the protocol, you will lose the newly-added information. Furthermore, WISER will not prompt you to save your data. 5 P a g e

6 While the Main tab is selected on the vertical menu, continue building your protocol in this order: 3. Continue addressing the data fields on the Details page: Title (Study Full Title) Short Title Objectives (Abstract) Phase Scope Age Indicate whether the study o is an Investigator-Initiated Protocol o Involves Therapy o is a Multi-site Trial o involves an Investigational Drug o involves an Investigational Device Exclude Protocol on Web checkbox (refers to adding to the Be Involved website) Protocol Target Accrual (Accrual at all sites) RC Total Accrual Goal (both Lower & Upper) RC Annual Accrual Goal Accrual Duration (Months) Primary Completion Date 4. Select the (horizontal) Management tab and add your Management Group(s). o Under the Administrative Groups section at the bottom of the page, click Select and choose your group(s) from the generated list, then click the Add button. (If no Select button displays, look for an Update button.) o If nothing happens when you click the Select button, a pop-up blocker is likely to blame. Disable pop-up blockers for WISER and try again. 6 P a g e

7 5. Select the Staff tab, click Update if the page is read-only when accessed, and enter the roles and names of all staff that will work on this protocol. Simply select a role, locate the staff member under Staff Name (search by last name), and click Add to load the name. This action saves the data on the page. If you have already created Protocols in WISER, you may also choose to shortcut the Staff entry by clicking the Select Team button at the top right of the page. Select Team This will open a page that allows you to select another Protocol, click the Show Team button, and choose one or more of the team members from that study: Once the team members are selected and submitted in this prompt, they will populate the Staff page. 7 P a g e

8 ***Please note that a Principal Investigator and a Protocol Coordinator are required Staff for every study. Furthermore, one person can be given multiple roles for your study. 6. Select the Documents/Info tab on the vertical menu. Select Update, which triggers an Add button at the top right. Click this to open the add attachment template. Choose a Document Type, attach your file or enter a URL, enter a Version Date, and then click Add. You may follow these steps to add as many documents as necessary. Upload versions of the following documents (as applicable): o Draft Contract o Draft Sponsor Budget o Internal Budget (as applicable) o Ancillary Contracts Enter Your IRB Application Although there is more required information for your new Protocol, at this point you have entered all the information necessary to begin your eirb application. The WISER and IRB applications can run concurrently; therefore, you may log in to eirb at any point from this time forward in order to create your eirb application. You will be asked to enter your WISER Protocol number, and once provided, the following information will load into your eirb application from WISER: o Title (Study Full Title) o Short Title (Study Short Title) o Objectives (Abstract) o Phase o Whether study is Investigator-Initiated o Whether the study is multi-center (multi-site) 8 P a g e

9 o Whether an Investigational Drug is included o Whether an Investigational Device is included o Protocol Target Accrual (Accrual at all sites) o RC Total Accrual Goal (Upper) ( Actual expected enrollment in eirb) o Accrual Duration (Duration of Recruitment) o Study Team Don t Forget: The following must be uploaded into the IRB application in order for the OCR to begin building the Calendar, MCA, and Budget in WISER: Consent Forms Protocol Document IDE/IND Documentation Investigator Brochure To continue completing your WISER Protocol, you will need to enter and complete data for the following: Sponsor o Select the Sponsor tab, then click the Add Sponsor button to generate a search field. o Begin typing the name of the Sponsor until located in the dropdown menu, and then click the Add button to the right of the field. o Enter Sponsor Protocol No., then address Principal Sponsor checkbox. o Select Submit to save the entry. o You may repeat these steps to add more Sponsors. Treatment (Study Arms) o Enter Step Code 1 and click Add. Only one Step Code is needed for any number of Arms. 9 P a g e

10 o Click the Arms link to begin creating the Arm(s) for your trial. o Enter an Arm Code and a Description, selecting Add after each entry. Be sure to Submit once complete. o If applicable, add Modalities/Drugs/Devices for each Arm: Click the referenced link, then select from the dropdown for the applicable Modality, Drug, and/or Device, being sure to click the related Add button after each selection. Then click Submit. o Add Levels (if applicable) Select the Levels link and enter the Level Code and Description, being sure to click Add once this data is complete. Select Submit. 10 P a g e

11 Click Disease/Diagnosis and then Select to open a list of Diagnosis Groups. Click the desired checkbox, then click Add at the bottom of the page. Institution (Study Sites) o Click the Add button to generate an Institution search field. Locate Wake Forest Baptist Medical Center as a site, and other participating sites and networks, as needed. Click Save after each selection to load the site into the page. I m pretty sure I m done creating my Protocol. What now? As soon as you submit your IRB Application, these events are triggered: 1. If your study does not involve a Cancer Diagnosis, the IRB number will replace the original number generated by your Protocol. 2. The Office of Clinical Research (OCR) Team receives a notification. They will then begin to review the PC Console and will add the appropriate Clinical Research Financial Analyst (CRFA). They will also: a. Build the Study Calendar b. Complete the Medicare Coverage Analysis (MCA) c. Complete the Budget Build for the Study d. Copy the WFBMC Study Initiation Comments template from the Library within the PC Console, and then complete and release the template to create a Task List. They will then add a target date for the Study Team signoff. Finally, they will click Complete on the Specification page. 11 P a g e

12 e. This will trigger a notification to the Study Team to address the approval: Spec, MCA, and Budget Signoff. Task Lists A Task List is like a notification system. Task Lists are used to indicate the required signoffs, target dates, and responsible person(s) for completing the signoff. Once a task list is released by the Office of Clinical Research, if you have configured your home screen to include Active Tasks and Upcoming Tasks, these tasks will be displayed when you open up WISER. Once the signoff is complete (see the next section), you will need to manually address the Task List to indicate completion: Select the link in the home screen section to access the task list, or manually navigate to the Task List: PC Console > Select Protocol > Status > Task List Enter a Completed Date to indicate approval, then click SAVE. The task becomes Active for the next step in the list, and is removed from your Active Tasks. Please note that, if there are issues or concerns about the signoff, you can also use the Task List to enter communications to be read by other users on the task list. You can also add files and URLs as attachments to a Task. 12 P a g e

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