FormsNet3 SM Cord Blood Bank Training Guide

FormsNet3 SM Cord Blood Bank Training Guide

Welcome to the FormsNet3 SM Application The FormsNet3 SM application suite is a clinical research management system that brings together researchers from around the world to share knowledge and answer questions critical to saving lives. FormsNet3 builds upon the capabilities that were in FormsNet2 SM and provides features and functions that our users requested. These features include simpler site navigation and auto population. Key Benefits of the New System Improved user experience Quicker form processing Increased efficiency Simpler data capture Application Training This practical Training Guide is written to accompany webinar training for the application and to use as a resource afterward. Please share your comments or any questions about this Training Guide by sending an email to: CIBMTRTraining@nmdp.org You can also call CIBMTR to ask for additional help learning to use the application. Recommended Internet Browsers To fully support the upgraded features and tighter security standards in FormsNet3, our IT department recommends the following browsers for optimal performance of the application: Internet Explorer 9 (Note: Windows 7 as the operating system) Mozilla Firefox: 14 and greater Google Chrome: 22 and greater Safari: 6 and greater Internet Explorer 8 with Google Chrome Frame (plug-in to IE 8) Note that IE8 is the preferred browser for the NMDP EmTrax application scheduled for release in 1 st quarter 2013. If you are having system difficulty and cannot login to the application, call: NMDP Service Desk: 1-800-526-7809 x 8123

Table of Contents Access Login... 2 Log off... 3 Site Navigation Definitions... 4 Home Setting personal preferences... 5 Messages... 5 Cord Blood Forms Search for a form... 6 Search functionality... 7 Cord Blood Information Grid... 7 Create an unscheduled form... 8 Form Status and Colors... 9 Error Report... 9 Form Change History... 10 Form Change History Grid... 11 Filtered Groupings... 11 Form Layout Form action icons... 12 Title bar... 13 Form Action Menu... 13 Form action icons... 14 Answer types... 15 Question enabling... 15 Form section bar... 16 Go to Top... 16 Click vs. Tab navigation... 17 Field Level Saving... 17 Multiples... 17 Date and Time fields... 18 Error Message, Override... 19 Clear field... 19 Field Change History... 20 Grid functions... 21 Admin Security Toolset... 22 Add/Remove security roles... 22 User role functions... 23 Glossary Pages... 24-25

Access Why do Cord Blood Banks need to use FormsNet3 sm? In order to receive email notifications when Transplant Centers submit Adverse Event Reports and Product Compliant Reports, you need to have access to FormsNet3. This application is also used to submit Product Deviation Reports. Setting up an account You will need a National Marrow Donor Program User Account and a SecurID Token. These can both be requested by going to this web URL: https://nmdp.service-now.com/servicecenter/ Follow instructions for NMDP Partners. Please indicate in the comments that you need a SecurID Token and FormsNet3 Access. You must include your CIBMTR Research Center PIN Number (4 digits). If you have any questions about account setup, call: (800) 526-7809 x8123 Once you have agreed to the EULA statement, your account is fully activated and you can login to the application as follows: Login 1. Access the application through the Internet at https://connect.nmdp.org. Enter your LDAP (see glossary) username in the top space of the box to the right. Then enter your PIN Number (4 digits) plus the SecurID Passcode from the Token, without any spaces in between them, into the bottom space. Note: The Token number changes every 60 seconds. If you miss entering it completely before it changes, you must start entering the number over. Select FormsNet3 from the next menu. FormsNet3 Cord Blood Bank Training Guide 2012 2

Access 2. Login to FormsNet3, again using your LDAP username and password. (Same login as it was for FormsNet2.) Note: Inactivity of more than 20 minutes will require you to login again. Log off Log off when you leave your desk to keep files in FormsNet3 secure. Click on Log Off, at the top of the screen. You will see Signed Off as confirmation. Help If you are locked out or cannot Login to the application, click on Forgot Password, or call: NMDP Service Desk at 1-800-526-7809 x 8123 FormsNet3 Cord Blood Bank Training Guide 2012 3

1 Site Navigation 2 3 4 5 In FormsNet3, you are one click away from every screen you want to see. The following definitions explain these simple site navigation features. 1 Browser arrows These arrows work as they would in any browser enabling you to select the forward arrow to move ahead a screen and the back arrow to move back one screen. 2 Quick Links These hyperlinks are at the top of every screen. One click on a Quick Link opens another window or tab, without leaving your current screen. 3 Tabs Underlined text in a red tab lets you know which screen you are in. Click on a different tab to change location and it will turn red and be underlined. 4 Menu bar The menu bar contains features that are specific for the tab selected. Menu bar links will change depending on which tab you are in. 5 Breadcrumbs This feature shows the path of screen changes that the user took in the application since logging in. These screen changes, separated by (>) brackets, display at the top of the current screen. Clicking on a breadcrumb opens that screen. FormsNet3 Cord Blood Bank Training Guide 2012 4

Home In the Home tab, you can navigate to: Set your personal preferences Receive Recipient and System Messages Setting your personal preferences Your Personal information is displayed based on your login credentials under My Profile. Be sure your name and email are correct on this screen as this information will display on any form you submit. Personal Preferences only need to be set once, not each time you access the application. Changing these viewing preferences affects the display of all grids that you access. Try different options to decide what you prefer: Choose whether to display colors in your grids. Choose the number of records that you want to see in grids at one time. Click on Submit to save your changes. * screen shot of home>my profile Messages CIBMTR will post information for Users regarding the FormsNet3 System in the Messages box. Specific news, updates, and links to resources may be found in the Recipient messages box. FormsNet3 Cord Blood Bank Training Guide 2012 5

Cord Blood Forms In Cord Blood Forms, you can navigate to: Search for a Form Create an Unscheduled Form View an Error Report Review Form Change History Cord Blood Forms Screen Click on the Recipient tab, and you will see the Cord Blood Forms screen. FormsNet3 Cord Blood Bank Training Guide 2012 6

Cord Blood Forms Search Functionality You can look up forms by selecting one of the following in the Search by Type dropdown list: 1. CBU ID This will return all forms that have this specific CBU ID on them. 2. Cord Blood Center Number The CIBMTR Center Number must be used. (4 digits). This will be the most common search criteria used and will return all forms, in all statuses for the center entered. 3. ISBT DIN This will return all forms that have this specific ISBT ID on them. 4. CBB Local RID This will return all forms that have this specific local Recipient ID on them. This ID is only captured when Form 2007 has been submitted for a unit. 5. Registry CBU This will return all forms with this specific Registry ID. The Registry assigned ID is only captured when Form 2007 has been submitted for a unit. 6. CRID This will return all forms with the specific CRID on them. The CRID is the ID the Transplant Center has assigned to the Recipient. 7. Sequence Number This will return the specific form with the sequence number entered. The default Search by Type is CBU ID. Once the user selects the Search by Type, the appropriate number can be entered in the Search For box, then click Search. The system will return all information available for the Search by Type, and Search For criteria. Data available for the search criteria you entered will populate in the Cord Blood Information grid and also into the Forms grid. Cord Blood Unit Information Grid The first grid on the Cord Blood Forms screen is called the Cord Blood Unit Information grid. In this grid the following information will be displayed: 1. Create Unscheduled Form Icon 2. CBU ID (NMDP) 3. CBB CCN 4. Registry Number 5. Event Date 6. Study Name (If applicable) 7. NMDP RID 8. CRID 9. NMDP TC 10. Infusion Type FormsNet3 Cord Blood Bank Training Guide 2012 7

Cord Blood Forms Create an unscheduled form Click on the Recipient tab. Your screen should now display Cord Blood Forms. If you have an active role in more than one CIBMTR center, you may need to click on Cord Blood Forms in the red bar. Click on the Unscheduled Form icon. A pop-up box saying Create Unscheduled Form will appear. Select the form 3011 to submit a Product Deviation. This form should be completed as soon as possible after identifying the product deviation, and must be completed within 3 days of the discovery of the issue. Additional instructions for completing the Form 3011 can be found here. New Feature If you change your mind, you can click the Cancel button. When the system returns to the Forms screen, your original search criteria will be retained. Help Product Deviations include anything that could potentially impact the safety, quality, identity, purity, or potency (SQuiPP) of a cord blood product or failure of a lot number or any of its components to meet any of its specifications. [paraphrased 21 CFR 211.192] Form status The current status of the form is displayed in the second column of all form grids. Color display can be set in My Profile, under the HOME tab. You can choose whether to display the color for the whole row, just in the status column, or to have no color. Status abbreviation meanings and color examples are in the following chart: FormsNet3 Cord Blood Bank Training Guide 2012 8

Form status and colors Purpose Form has not been started Form is complete Form has errors Form saved Form modified Form is locked Form is locked for audit purposes Form in evaluation status Color DUE CMP ERR SVD MOD LCK AUD RVW Cord Blood Forms Error report An Error Report is generated for any form submitted with unresolved errors or any overridden errors. Click on the Error Report icon located in the form track row in the first column of the grid. You will be directed to the Error Report page. The Error Report grid utilizes the same functionalities (export to Excel, sorting and filtering on all columns) as any other grid. FormsNet3 Cord Blood Bank Training Guide 2012 9

Cord Blood Forms Form Change History The Form Change History (known as the Audit Trail in FormsNet2) allows you to see previous form changes and the Username for who made the prior submission. Look in the first column of the forms grid, under Cord Blood Forms, in the Recipient tab for the icon. The Form Change History icon is present in the first column once a form has been submitted. Click on the icon to be navigated to the Form Change History of the specific form on the row that you selected. You can choose how to display information in several ways: Grouping by Submitted or User Name - Click on the small triangle in front of the word. Pointing down expands, and pointing up collapses the whole group at once. These expand/collapse triangles function the same way in the column headers of the Question section of the Form Change History grid. Clicking on the red x will close the display grouped by that word type. If you close in error and want to see the grouping again, use the return arrow in the Title bar, or breadcrumbs to return to your previous screens. Next to the word Submitted is the date of submission. Clicking on that arrow expands or collapses a dropdown that shows who made submissions by their User Name. Clicking on the arrow before User Name expands the row and displays all the question information entered by that User. FormsNet3 Cord Blood Bank Training Guide 2012 10

Cord Blood Forms Form change history grid Submitted information is categorized under the form column headers. The column will be blank if there is no information to display. Creating a filtered grouping Drag the selected column header to the light blue grid header. An indicator on the screen shows you the right location when you are near it. For example, if you would like to look at the history for one particular question, drag the Question # column up to the grid header, by doing the following: Hover over the column header until it is highlighted. Click on your mouse and hold the click down to drag the column header to the grid header. A + sign before your column title lets you know that you can release your click. The grouping will display. All columns can be sorted or filtered and the resulting grid can be exported to Excel. FormsNet3 Cord Blood Bank Training Guide 2012 11

Form Layout Form action icons These icons are displayed in all form grids. Create New form Opens the form and allows you to enter data. Edit form Opens the form in edit mode allowing you to make changes to the form. View form in View Only Mode Opens the form, but you will not be able to enter any data or make any changes to the form. View form in PDF Opens a Legacy form in FormsNet2 in a PDF format. (Note: only forms that were completed prior to FormsNet3 will have PDFs.) View Error Report Opens the error report for any form that has been submitted with unresolved errors or had any overridden errors. View Form Change History Opens the form change history for that specific form. (Note: the Form Change History was called the Audit Trail in FormsNet2) Lock Indicates that the form is locked for audit, or CIBMTR has locked it for another reason. While the locked icon is displayed you will only be able to access the form in Read Only Mode. FormsNet3 Cord Blood Bank Training Guide 2012 12

Form Layout Form Title Bar Every form has a Form Title Bar. The information in the Form Title Bar is standard across all forms and remains stationary as you scroll through the form. The Form Title Bar contains the following information: Form number 3003 Form Revision number R2.0 Form title Adverse Event Follow-up Form CRID 0000000606 Visit ID AE-FU-24 Form Status ERR Help You must be in Edit Mode to enter or change data on the form. View Mode only allows you to view the form. Look on the Form Action Menu to see which mode you are in. Form Action Menu Under the Form Title Bar, there is a Form Action Menu, which contains various icons. Clicking on these icons makes various actions occur, such as: navigate through the form, return to the forms grid, and submit data to CIBMTR. See the following page for a detailed description of the Form Action Icons. FormsNet3 Cord Blood Bank Training Guide 2012 13

Form Layout Form Action Icons Collapse/Expand all Sections All sections (including multiple sections) of the form will either expand or collapse. Clear Form Clears all data entered on the form except in the auto populated fields. The Clear Form icon only appears in the Form Action Menu for scheduled forms. Once the user clicks the Submit icon, the Clear Form icon will no longer be an option in the Form Action Menu. If you need to have your forms cleared or reset after it has been submitted, please contact CIBMTR. Cancel Form Cancels the creation of the form in its entirety. The Cancel Form icon will only appear in the Form Action Menu for unscheduled forms. Once you click the Submit icon, the Cancel Form icon will no longer be an option in the Form Action Menu. Print The system prints the form in its current state. Jump to Question Enter a question number in the Q# box and click the down arrow. FormsNet3 will auto populate the key field sections on all forms (excluding the Product Deviation forms). The name and email of the person completing the form will also be auto populated on all forms. Auto populated fields include the following: CRID Date of HSCT User s First and Last Name Date received Sequence number User s email address FormsNet3 Cord Blood Bank Training Guide 2012 14

Form Layout Answer Types The following answer types are used to complete questions within the forms: Dropdown boxes Radio Buttons Text Fields Check Boxes Question Enabling To ensure the user is answering all of the appropriate questions within a form, questions will be enabled based on answers to previous questions. If a field is disabled the user will not be able to enter data into that field. FormsNet3 Cord Blood Bank Training Guide 2012 15

Form Layout Form Section Bar All forms will have at least one Form Section Bar, which displays the section title and the question number range of the section, if applicable, along with the following information: Expand section Only that section will expand to expose the questions within that section. Collapse section Only that section will collapse to hide the questions within that section. Book A slide box appears with instructional information specific for that section. The Book icon only appears if there is instructional text available for that section. Form Section Status - Complete All questions within the section have been completed and meet validation rules or have had an override code applied. Form Section Status - Error At least one question within the section does not meet the validation rules or has been left blank. The form is incomplete, go back to make correction. Go to Top Depending on which browser you are in, there is a Go to Top icon that appears towards middle right hand side of the screen. Click the icon to return to the top of the screen. FormsNet3 Cord Blood Bank Training Guide 2012 16

Form Layout Click vs. Tab Navigation You can navigate through the form either by using your mouse to click to answers or by pressing the tab key on your keyboard. If the question on the form is a dropdown, radio button, or check box, once you click the answer to the question, the system will automatically move the cursor to the next question that must be answered. If the answer to the question is a text box, you need to use the tab key to automatically be navigated to the next question that must be answered. Field Level Saving FormsNet3 automatically saves the answer to each question when you navigate to the next appropriate question. Multiples Some questions or groups of questions on a given form can be repeated multiple times, the term Multiple applies to this feature of a form. Multiple Instances The specific occurrence of multiple(s) within a form, for example: Instance (1), Instance (2), etc. The multiple instance number displays in a parentheses after the multiple title in the section header. You can add a multiple instance by clicking on the section header or footer. on either the multiple FormsNet3 Cord Blood Bank Training Guide 2012 17

Form Layout Date and Time Fields FormsNet3 follows the ISO 8601 date and time standard. The date format for all date fields will be the following: YYYY-MM-DD. A watermark showing the date format is in each date field and a calendar icon is available for you to use to pick the date. The time format for all time fields will be the following: HH:MM. A watermark showing the time format shows in each time field and an icon is available for you to use to pick the time. Error Icon When you answer a question on the form and it does not meet the validation rules, the system will display an Error icon to the left of the field. FormsNet3 Cord Blood Bank Training Guide 2012 18

Form Layout Error Message, Override, and Comments: When you click the Error icon, the system displays the following: Error message for that question. If there are multiple errors on that question you can click forward to the next error message. The system displays the appropriate override codes for that question. Comments. If you need to enter an override code you can also provide a short comment to note why the field was answered the way it was. Help Some fields will not allow you to override an error. These fields must be answered. Clear Field Clear Field icon only appears on radio button answer types. When you click the Clear Field icon, the system removes the answer for that specific question only. FormsNet3 Cord Blood Bank Training Guide 2012 19

Form Layout Field Change History Once the form has been submitted and the user goes back into the form to change an answer to a question, the system displays a Field Change History pop-up box. The user must select a reason code to describe the reason for changing the answer before navigating away from the question or screen. The field change history codes display in the Form Change History (previously known as the Audit Trail in FormsNet2) for each form. FormsNet3 Cord Blood Bank Training Guide 2012 20

Grid Functions All grids within the FormsNet3 application have the same functions. These functions are: Export to Excel Exports the grid that you currently have displayed. Sort Click to the right of the column header you wish to sort and an arrow will be displayed. Click the arrow once to sort the column in ascending order. Click the arrow again to sort the column in descending order. Filter Click the filter icon to display a pop-up where you can enter criteria to filter the grid as you choose. Clear all filters Clears all filters that were applied. Grid Pagination Click on the page number or the arrows to navigate to the next page of the grid. Grid pagination is displayed at the top and bottom left of the grid. Number of Records Returned Based on search criteria you entered, the number of records returned displays at the top and bottom right side of the grid. FormsNet3 Cord Blood Bank Training Guide 2012 21

Admin In the Admin tab, you can navigate to: Access the Security Toolset Add/Remove security roles View User Role functions The Security Toolset, which is only accessible to the center s Primary Data Contact, is used to assign or remove security roles for staff that use FormsNet3. The LDAP Group dropdown lists all of the LDAP groups for that user. To add/remove roles: Select the LDAP Group that you want to edit. User Roles for that group will display. Under the Users dropdown, users in that particular LDAP group will populate. Select the user who needs security roles edited. To add a role to the selected user, click on the check box in front of User Role. To remove a role from the selected user, click on the green checkmark. Click Save. If you have a role in more than one Cord Blood Bank, you will need to have User roles set for each center. FormsNet3 Cord Blood Bank Training Guide 2012 22

Admin Security Role FN3_REC_CB_PRIMARY CONTACT Functions 1. Has access to create forms 2. Receives emails when Transplant Center reports Product Complaints and Adverse Events. 3. Can edit User roles. FN3_REC_CB_SECONDARY CONTACT 1. Has access to create forms 2. Receives emails when Transplant Center Reports Product Complaints and Adverse Events. Help Only one Primary Data Contact is allowed per center. When there is a change in this contact, please submit a Personnel Change Form, and also submit a FormsNet3 User Access Form to CIBMTR. Forms are located on our website at the following: http://www.cibmtr.org/datamanagement/adminresources/personnel/pages/index.aspx FormsNet3 Cord Blood Bank Training Guide 2012 23

Auto-population When a specific value is known, it will cause other fields on forms to automatically fill without requiring data entry. Errors on the initial source will repeat on future forms. If an error is noted, the source fields must be corrected. Breadcrumbs This feature shows the path of screen changes that the user took in the application since logging in. These screen changes, separated by (>) brackets, display at the top of the current screen. Clicking on a breadcrumb will navigate to that screen. CRID CIBMTR Recipient Identification is a unique identification number that is assigned to each recipient upon their first infusion by the Transplant Center, using the CRID tool in the FormsNet3 application. The CRID number will always remain the same on all CIBMTR forms for this recipient. Disabled Field A field that is not available for data entry due to the answer of a previous question. Enabled Field A field on the form that is available for data entry. Events and Actions Upon form submission, answers to certain fields trigger emails and/or specific forms to come due for completion. Expand or Collapse Each section in a form can be expanded or collapsed depending on how the user would like to view the form. This allows the ability to view section bars as open with all questions displaying (expanded), or closed with just the section bar showing (collapsed). Field Each question on a form consists of one or more spaces where data is entered. Glossary Field Change History If a user changes the answer to a question on a form that was previously submitted, a pop-up box will appear next to the changed field. The user must select a reason code to explain why the answer was changed before navigating away from that field. Field icons Appear to the left of the question number within a form and are based on the answer given to that question. They indicate the question status, examples: error, locked. Form Track Row Each form will have a designated row within any Forms grid. The row allows the user to access the action icons and view overall details for each form. FormsNet3 Cord Blood Bank Training Guide 2012 24

Form Status The form status indicates to the user the progression of the form. The current status of the form is displayed on the Forms Grid. LDAP / LDAP GROUPS Lightweight Directory Access Protocol (LDAP) is a Microsoft program which functions as the directory management service for CIBMTR. Data Managers use the same LDAP username to enter several CIBMTR programs, including: the former FormsNet2. Multiples Some sections on a form can be answered more than one time. Examples include product identification, IDM test results. Non-Override Validation Some fields have non-override validations that require an answer. If the answer does not meet the validation rule, an override code cannot be selected. Override Code When a field doesn t meet the validation rule, a reason code must be selected to describe why the validation rule was not met. Question Enabling Form questions are enabled based on answers to previous questions. This feature ensures that all appropriate questions within a form are being answered. Quick Links These hyperlinks are at the top of every screen. One click on a Quick Link takes you to another window or tab, without leaving your current screen. Save (Saving) The system automatically saves each field as it is entered and you leave the field. Glossary Submit Formerly known as Process, now the Submit icon is the final step on a form to send the data to the CIBMTR database. Validation Rules that check for accuracy of data entered into the system. These rules look for acceptable data entry responses, words or number ranges for each field to ensure the data is clean, correct, and useful. FormsNet3 Cord Blood Bank Training Guide 2012 25

Thank you for contributing to the growth and success of CIBMTR. Writers: Lori Colt Training Specialist Sharon Ewer Business Systems Analyst Elizabeth Johnson Clinical Research Coordinator Karen O Connor Project Manager Reviewers: Jennifer Bloomquist Marie Matlack Janet Brunner Kay Gardner And the CIBMTR Data Management Staff FormsNet3 Cord Blood Bank Training Guide 2012 26