Microsoft NCTSN CDS Reference Manual Version 2.0 Revised 20042018 BLACKBERRY ID SWD 1590032 0505111339 001 Vers2.0
User Manual: BLACKBERRY ID SWD-1590032-0505111339-001
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NCTSN Core Data Set Reference Manual 1 Version 2.0 Revised 20041018 1 Table of Contents Topic Page Number Glossary 4 System overview 5 System requirements 6 Security features 7 Browser basics 8 Access and Log-in 9 Screen layout 10 Passwords 11 NCTSN-InForm Home page 14 Help! 15 Log-out 21 Enroll a client 22 2 Version 2.0 Revised 20041018 2 Table of Contents Topic Page Number Enter, edit & save data 24 Navigate through InForm 28 Queries 36 Audit Trail 42 Comments 44 New follow-up visit form 48 Admin 49 Exports (Listings) 50 Reports 51 Printing 52 New User Accounts 55 New Center Sub-Center Accounts 56 3 Version 2.0 Revised 20041018 3 Glossary of InForm Terminology Case Report/Record Form (CRF) Paper version of a data collection form Return Go back to the previous screen eCRF Electronic data collection form/screen Submit Save data in the database Case Book/Case Record Book (CRB) Complete set of all data collection forms or screens Patient Client/child who is or will be enrolled in the Core Data Set Enroll Create a case book for a client/patient Listings Files of client data for review & interim analysis Reports Client level summaries of standard assessment scores 4 Version 2.0 Revised 20041018 4 Overview: What is InForm? – Web-based Electronic Data Capture (EDC) tool selected by the NCTSN to use for the Core Data Set – Enables NCTSN Centers to enter client data into an electronic Case Record Form – Data are automatically stored and maintained in a database via the Internet 5 Version 2.0 Revised 20041018 5 System Requirements • • • • • • • Pentium II processor Display 1024 x 768 resolution 64 MB memory 6GB hard drive MS Windows 98 or later High Speed Internet connection Microsoft Internet Explorer version 5.5 or higher 6 Version 2.0 Revised 20041018 Set your monitor to 1024x768 resolution to assure that you’re seeing the entire InForm data entry screen. To check the resolution on your monitor: Click the Start button in the bottom left corner Click Control Panel Click Settings Click Display Make sure you see 1024 x 768. If you’re still having trouble, check your web browser font size. Make sure it’s set to “smallest”. On your Browser Toolbar: Select “View” Select “Text Size” Select “Smallest”. This is especially important if you want to view NCTSN patient level reports. 6 Security Features • Password (PW) Protected: Each user has a unique ID and PW. This combination acts as an electronic signature. • InForm requires re-identification of User after 5 minutes of inactivity • InForm requires re-identification of User after 120 minutes of continuous activity • 128 bit encryption like the banks use 7 Version 2.0 Revised 20041018 7 Browser Basics • Recommended Internet Browser: – Microsoft Internet Explorer, Version 5.5 SP 2 or higher • The InForm web application: – – – – – – Is a Mouse-driven application Is a One-Click system (use the left button on your mouse) Supports only the PRINT button of the Internet Browser Do not use the BACK or FORWARD button on the Browser toolbar Do not use “keyboard” shortcuts (ctrl + C, etc) 4 ways to know the system is “thinking” vs “not responding”: • Hourglass • Spinning globe icon in top right corner • Status bar with Java script near the bottom of the screen • Progress bar changes from gray to blue as the forms load 8 Version 2.0 Revised 20041018 8 Access & Log-in 1. 1. Type Typethe theWeb WebAddress/URL Address/URL 2. 2.Type TypeUser UserName Name (Case-Sensitive) (Case-Sensitive) 3. 3.Type Typedefault defaultPassword Password (Case-Sensitive) (Case-Sensitive) 4. Click “Log Click Log In 4.4. Click “Log In” 4. Click LogIn” In 9 Version 2.0 Revised 20041018 Training System can be found at https://www.webcrf.net/trainnctsn/. Use the Training ID and Password assigned by the Data Center. You’ll be notified of the URL for the “Production” website and will receive an ID and Password for that system after you’ve completed the training exercises. 9 InForm Screen Layout Navigation Pane Content Pane Content-Specific Pane 10 Version 2.0 Revised 20041018 10 Passwords 11 Version 2.0 Revised 20041018 • • • • • • User Name and Password are required to use InForm. The User ID and Password ensure that only authorized personnel gain access to the NCTSN Core Data Set. They also allow InForm to track activity during data entry or amendments You’ll be assigned a user name and an initial password You’ll be asked to change your password the first time you use it to log in. Change it by using this process: 1. Enter your User Id 2. Enter the old password 3. Create and enter a new password (Do NOT use the Caps Lock button) 4. Confirm the new password 5. Click “submit” The password should meet the following criteria: 1. Use a combination of letters (upper and lower case) and numbers (8-32 characters) 2. Passwords are case sensitive. Do NOT use caps lock 3. Easy for you to remember but difficult for someone else to guess 4. Do not write down or share your password (Fraud) • As a security feature, you’ll be asked to change your password every 120 days. The system will prompt you to do so at the appropriate time. • After 3 unsuccessful log-in attempts, your account will be inactivated. Call 919-668-8182 or email NCTSN@dcri.duke.edu & ask for it to be re-activated. • Passwords can only be used once. You may not reuse the same password. 11 Forgotten Passwords • InForm has a built in mechanism that you can use to get a new password if you forget the old one. • After the First Failed Log-in Attempt, the Forgot Password feature will display on your Log-in Screen. • This feature works ONLY if you’ve entered a “trigger” question during the Password change process. 12 Version 2.0 Revised 20041018 •Click the “Forgot Your Password” hyperlink. •Read the Trigger Question that displays & type in your answer. •Click the “Get New Password” button InForm (nobody@webcrf.net) will send you an email with a system generated password. Use it to log in and reset your password to something you can remember easily, but that will be hard for someone else to guess. Remember, Passwords are case specific. Don’t use caps lock. The email reads like this: **** PLEASE DO NOT REPLY TO THIS MESSAGE **** Dear XXXXXXXX, This email confirms that your temporary password is the following: Temporary Password: KOWoH8Ry Please note this password is case sensitive and must be entered exactly as it appears above. Use this password the next time you login. After logging in, you will be prompted to change your password. For further inquires, please contact trial administrator. **** PLEASE DO NOT REPLY TO THIS MESSAGE **** 12 “At Will” Password Change Use the NCTSN Logo on the Home Page to change your password if necessary. 1. 2. 3. 4. Click the NCTSN logo Enter your old password Enter your new password Enter your new password again to “confirm” it 5. Enter a “Trigger” question that will help you recall your password in the event that you forget it. 6. Enter the answer to your question 13 Version 2.0 Revised 20041018 13 NCTSN Home Page The HOME button takes you to the NCTSN Core Data Set Homepage NCTSN@DCRI.DUKE.EDU 14 Version 2.0 Revised 20041018 14 HELP! If you have questions regarding the InForm system, use InForm’s HELP functionality to find your answers. 15 Version 2.0 Revised 20041018 HELP button on the Navigation pane: • Content view: Like the table of contents of a book; broad subject areas (i.e. Chapter on “Meat” in a cookbook) • Index view: Like the index of a book; more specific areas (i.e. Recipe for Santa Fe Chicken) Hover help: Hold your mouse button over an icon & note the descriptive message that displays briefly eHelp: Underlined text will often take you to a page with additional information about that item 15 HELP! Find topics using the “Table of Contents” view or the “Index” view. 16 Version 2.0 Revised 20041018 16 HELP Table of Contents View Index View 17 Version 2.0 Revised 20041018 17 Hover Help 18 Version 2.0 Revised 20041018 Position your mouse over any button, icon, or underlined text. A message describing it displays for a short time then disappears. The examples on this slide display when you hover over a Traffic Light, underlined patient ID # or the ‘Reports’ button. There are many other locations where “Hover help” is available. 18 eHelp Underlined text often take you somewhere else in the system. Click this one to go to information about the Baseline Visit and Demographics screen. 19 Version 2.0 Revised 20041018 19 HELP with NCTSN-specifics 20 Version 2.0 Revised 20041018 20 LogOut Use the Log-out button to tell InForm that you’ve finished using the system. – NOTE: Closing your Internet Browser window does NOT log you out of InForm. 21 Version 2.0 Revised 20041018 21 Enroll a New Client Screening and enrolling is the process InForm uses to create an electronic Case Book for the clients who will participate in the Core Data Set. 22 Version 2.0 Revised 20041018 Follow these steps: Click Enroll on the Navigation pane Click Add Candidate in the bottom right corner of the screen Enter the client’s initials, date of birth & gender Click Submit Find your client in the list & click the Enroll button on the far right Select the checkbox asking if you want to Enroll this client and click Submit. Click Enroll on the bottom of the screen if you want to proceed. Note: The Patient Number is your Center ID + Subcenter id (if applicable, or 00) + sequential number generated by the InForm beginning with 00001. The screening number is created first as a placeholder until the Enrollment process is complete. Note: To see the enrollment information for your client from other screens in the system, follow these steps: 1. Click the “Enroll” button in the Navigation pane & see the “Screening Log” 2. Click the underlined Screening Number for your patient 22 Patients = Clients Click the ‘PATIENTS’ in the navigation pane to see the list of all clients from your Center who are enrolled in the Core Data Set. 23 Version 2.0 Revised 20041018 Note: You can see the following at a glance: •List of Clients/children who are enrolled from your Center •The Visits for which they have data entered (Baseline, Trauma, Follow-up) •The status of their data (Traffic lights) If you are responsible for clients at multiple Centers, select the Site of choice or “All” from the dropdown box in the top right corner of your screen to see more clients. Note: A click on the patient number (ie 2001-00-00004 (ABB) ) takes you to the Time and Events schedule where you see complete list of forms for that patient A click on a traffic light takes you directly to the data entry screens for that Visit 23 Enter Data 3 ways to Enter data 1. Select from Drop Down Box 2. Click on a Radio Button 3. Type into a Text Field 24 Version 2.0 Revised 20041018 24 Edit = Change 3 ways to CHANGE data 1. Click the data field and backspace over the current entry 2. Highlight the incorrect entry and use the Delete key on your keyboard 3. Click the Eraser Icon (looks like a Bar of Gold or Bar of Butter) 25 Version 2.0 Revised 20041018 25 Submit = Save • The Submit button is the method used for sending data to the InForm database. • Packets of information are encrypted and sent across the Internet to the InForm server 26 Version 2.0 Revised 20041018 26 Submit = Save • Microsoft sends a confirmation message that lets you know the data reached the database successfully • Click OK to continue 27 Version 2.0 Revised 20041018 27 Navigate through InForm PATIENTS button Click to see a list of all clients enrolled from your Center Patient Number Click to see the Time and Events Schedule (all forms for that client) Traffic Lights Click to go to a specific set of forms Arrows beside the Page Number Click to display additional clients who have been enrolled by your Center. 28 Version 2.0 Revised 20041018 28 Navigate through InForm Yellow Arrow Up Click to see the Time and Events Schedule Visit Ruler Bar Click to go quickly to each set of forms (Baseline, Trauma & Follow up) Tabs Click to move on to a new form (screen) List of most recently used records Click to see recently used forms for a client 29 Version 2.0 Revised 20041018 29 Time and Events Schedule A “Tree-top” view of all forms (eCRF’s) for a particular patient From the data entry screen, click the “Yellow Arrow Up’ to display it. From the list of patients, click the patient’s number (ie “1001-00-00002”) to display it. 30 Version 2.0 Revised 20041018 The “Yellow Arrow Up” is located beside the Visit Ruler Bar in the top right corner of the eCRF’s (data entry screens). Click a traffic light to go to a specific eCRF 30 Visit Ruler Bar Takes you quickly to sets of forms/screens Baseline: Collected near the beginning of treatment. • Demographics • Insurance & Domestic Environment • Indicators of Severity • Services Received • Clinical Evaluation • Standard assessments (PTSD, TSCC-A, CBCL) Trauma: Completed at baseline & updated during treatment as new information is learned. • General Trauma Information • Trauma Details Follow-Up: Completed during and at the completion of treatment • Follow-up visit information • Treatment by NCTSN Center • Standard assessments (PTSD, TSCC-A, CBCL) 31 Version 2.0 Revised 20041018 Instructions about completing each set of forms are found by clicking the “Documents” button on the navigation pane. See slide #20. Click a traffic light to go to a specific eCRF 31 Tabs Take you quickly to a new form (screen) Tab names are abbreviated names of the forms. Each tab corresponds to a particular section of the Core Data Set. These tabs are examples of those found in the Baseline Visit: Demo = Demographic information InsDom = Insurance & domestic environment IndSev = Indicators of severity SerRec = Services received ClinEval = Clinical evaluation CBCL = Child Behavior Checklist 32 Version 2.0 Revised 20041018 Refer to the Time and Events Schedule in InForm to see a complete list of Form names and abbreviations found on the Tabs. To reach the Time and Events Schedule from a Data entry screen: Click the “Yellow Arrow Up” located at top of the screen beside the Visit Ruler Bar located near the top of your screen. To reach the Time and Events Schedule if you’re not on a data entry screen: Click Patients Click the underlined patient number To reach a data entry screen from the Time and Events Schedule: Click a traffic light by the intended form under the intended visit (Baseline, Trauma, or Follow-up) 32 Return = Back RETURN takes you back to the screen you were using just prior to the current screen. • It’s the same as the “Back” button/green arrow on your Browser toolbar. 33 Version 2.0 Revised 20041018 Use the Return button in InForm; do not use the Back button on your Browser toolbar. 33 Traffic Lights Traffic lights tell you the status of the data – Red light = Query/Question about the data – Yellow light = Missing data – Green light = Form is Complete. – Black light = No data has been entered on that form. 34 Version 2.0 Revised 20041018 34 Data Validation Users Usersare arealerted alerted immediately immediatelyto todata data format discrepancies format discrepancies 35 Version 2.0 Revised 20041018 •Prevents data submission until data are corrected •Ensures data format is correct Numbers vs. Characters Decimal requirements Valid Ranges 35 Queries Queries are “Questions about the data”. 3 ways to know you have a query: – Red traffic lights – Red data fields – Yellow flag 36 Version 2.0 Revised 20041018 Two types of Queries Automatic Queries - generated when you submit data that lies outside the parameters set for that data item. Manual Queries - created by Data center and issued for Centers to review 36 Status of Queries 3 possible states of queries: – Opened – Answered – Closed Click the “Queries” button on the Navigation pane to see a list of queries for your Center. There may be more than one query for each patient. Status is found in the far right column. 37 Version 2.0 Revised 20041018 Queries have the following states: Opened Queries Active queries awaiting a response by Center personnel Answered Queries Queries which have been responded to by Center personnel and are awaiting review by the NCTSN Data Center Closed Queries Queries which have been resolved and closed by InForm or the NCTSN Data Center Use the dropdown boxes at the top of the list to sort the queries. You may sort by one variable at a time. Sort by: Center ID (if you have access to data at more than one Center) Status of queries (open, answered, closed) Person who issued (created) the query 37 Answering Queries There are 2 possible responses: Option 1 • The data was entered incorrectly & must be changed Option 2 • The data was entered correctly, InForm just doesn’t recognize it as a valid answer for that question. 38 Version 2.0 Revised 20041018 38 Answering Queries Clinician enters 3 for “Number of adults living in child’s home” but indicates that 4 types of adults live with the child. Autoquery fires: “Number of children living in child’s home is fewer than number of Types of adults living with the child. Please clarify.” OPTION 1 OPTION 2 Clinician reviews chart and corrects value to 4 in and indicates Reason for Change: “Transcription error” Clinician reviews chart and confirms entry is correct; indicates “Original Value is Correct”. The data “Is what it is”. InForm recognizes new value is within range. Status changes to Query Status = Closed InForm recognizes the query is answered, but value does not satisfy query. Status changes to: Query Status = Answered 39 Version 2.0 Revised 20041018 39 Answering Queries 3 2 1 4 5, 6 40 Version 2.0 Revised 20041018 To answer a query from the Data Entry Screen: 1. Read the red underlined message that tells you why the query fired. 2. Hover your cursor over the field where data needs to be changed and click once. InForm will take you to the Data Values Tab where the data can be changed. 3. Click the field a second time to correct the entry. 4. Scroll down and enter a reason for the change. InForm requires a reason for every change. You can select from the drop down list or enter your own in the “other” field located below the drop down box. 5. Click Submit. 6. Click Return to return to the data entry screen. 40 Answering Queries 3 1 2 4 41 Version 2.0 Revised 20041018 To answer queries from the List of Queries: 1. Click the Queries button on the Navigation pane. 2. Select the intended patient and query from the list. Note, all queries for all patients from your Center are on this list. There may be more than one query for the intended patient. Scroll through the list to find the intended query. 3. Click the underlined description of the query message. This takes you to a Query Tab; Do not make any changes on this screen. Click the “Data Values” tab located to the right of the Query Tab. 4. Enter the correct data & provide a reason for change. 5. Click Submit, found on the bottom right corner of screen. 6. Click Return to return to the data entry screen. The Return button is on the bottom right corner of screen 41 Audit Trail Documents all activities with the data – – – Creating Deleting Modifying Item Has Been Changed -- Click to View Audit Trail 42 Version 2.0 Revised 20041018 The Audit Trail is updated each time “Submit” is clicked. It tells you “Who did it” and “what they did”! User ID, Date, Time and type of activity (create, delete, modify) are recorded. Remember, “Once entered, always there…”! Audits contain the following information: Full Date, Time, User and Reason for Change Full Chronological Recording with no Obscured Records Audit trail is Read-Only Access – it cannot be modified. 42 Audit Trail SiteUser 43 Version 2.0 Revised 20041018 The audit trail icon displays on the far right side of each item/question after changes have been made. Click it to see details about the changes made to the item. Note: You can move easily from the audit trail to the Data Values tab to make additional changes to the item if necessary. 43 Comments Comments are like “electronic post-it notes” • Comments can be entered on a ITEM or on an FORM No Comment Exists - Click to Enter a Comment Comment Exists -- Click to Update Or View Existing Comment 44 Version 2.0 Revised 20041018 To enter a Form Level Comment, Click on the Comment Icon in the top right corner of each screen. To enter an Item Level Comment, Click on the Comment Icon located on the far right side of the line item. 44 Comments 45 Version 2.0 Revised 20041018 This is an example of Comments & the comment history. Multiple comments can be made. To review the comment history, select from the drop down list. Note you can move easily to the Audit tab and Data Values tab to see the history of changes or to edit the data. 45 Not Done, Not Applicable, Unknown These fields are found on the Form Comment screen or the Item Comment screen when NO data has been entered Use “Not Done” if you are unable to get the data for that screen and do NOT plan to (or cannot) get that data at another visit. 46 Version 2.0 Revised 20041018 46 Dynamic Forms Dynamic Forms – Are created upon data submission; Triggered by answers to certain questions 47 Version 2.0 Revised 20041018 Example: On the General Trauma Information form, if you answer “YES” to “Has child experienced Sexual Assault/maltreatment?” & click Submit, the Trauma Detail form for Sexual Assault/Maltreatment is created. The “SexAssault” tab is now behind the “Trauma” tab. Another example: Inform creates a CBCL, PTSD &/or TSCC-A based on the age of your client. Age is calculated using the Date of Birth entered on the Enrollment screen and the Date of Visit on the Baseline or Follow-up Assessment form. The standard assessments forms display only when the client meets the age criteria established for the assessment. CBCL 1.5-5 YOA CBCL 6-18 YOA PTSD & TSCC-A 7-18 YOA 47 Create a New Follow-up Visit Form • Select “New” in the bottom left corner of the Follow-up Visit form • Enter the follow-up visit date and other data. • Click “Submit”. • Select visits from the dropdown box to see list of followup visits. 48 Version 2.0 Revised 20041018 Note: Additional pages/screens for the Follow up assessment are created when the data on the initial form has been submitted. 48 Admin • ADMIN button provides information about the version of InForm you are using 49 Version 2.0 Revised 20041018 This is an informational screen. It’s View Only. 49 Export Data to Excel (Listings) • The Listings function outputs data from the InForm to an Excel spreadsheet • Listings provide access to selected data for: – Review purposes – Interim analysis • Users can define items to output and recall the Listing (by name) for future use • Output can be saved locally to an .xls file or .csv file 50 Version 2.0 Revised 20041018 1. Click the Listings button on the navigation pane 2. Click the checkbox beside each item you’d like to export 3. Select a Visit (All Visits, Baseline, Trauma, or Follow-up) 4. Click Submit 6. Click Download 7. Click Open if you’d like to look at the file 8. Save the file to your PC if desired. If you’d like to create a Listing that can be used repeatedly, Complete steps 1-3 above Click “Save” in the bottom left corner & give your Listing a short name. InForm will create a list of Listings that display in the dropdown box beside Listing Report on the bottom right side fo the screen. Click Submit Click Download Click Open if you’d like to see your file OR click Save and identify a location if you’d like to save the data from your Listing to your PC. 50 NCTSN Reports • Custom reports available – Scores for the standard assessments • CBCL • TSCC-A (Briere) • PTSD 51 Version 2.0 Revised 20041018 1. 2. Click REPORTS in the Navigation Pane Select the intended report • NCTSN Scoring Report View Only • NCTSN Scoring Report Print by Visit 3. Enter complete patient ID number (Center ID – Subcenter ID – Patient number) 4. Select VISITS (required only for Print by Visit) 5. Click SUBMIT Note: Scores are generated only when a designated percentage of questions have been answered. If you’re having trouble seeing the entire screen (or the entire report on a screen), set your monitor to 1024x768 resolution to assure that you’re seeing the entire InForm data entry screen. To check the resolution on your monitor: Click the Start button in the bottom left corner Click Control Panel Click Settings Click Display Make sure you see 1024 x 768. If you’re still having trouble, check your web browser font size. Make sure it’s set to “smallest”. On your Browser Toolbar: Select “View” Select “Text Size” Select “Smallest”. This is especially important if you want to view NCTSN patient level reports. 51 Printing from InForm • eCRF’s and Reports may be printed – Click the “Print Preview” button – Then click the Printer icon on your Browser Toolbar 52 Version 2.0 Revised 20041018 52 More on Printing • An example of the output from “Print Preview” 53 Version 2.0 Revised 20041018 53 More on Printing Page Setup (under the “File” menu on your Browser Toolbar) may need to be adjusted for optimal printing. • Use Landscape orientation for Reports and the General Trauma Information eCRF. • Use Portrait orientation for other eCRF’s 54 Version 2.0 Revised 20041018 54 Request a New User Account • Complete the information requested on the NCTSN User Account Add/Change Form. • Email to: NCTSN@dcri.duke.edu 55 Version 2.0 Revised 20041018 This form is found in your packet of training materials & on the CD. 55 Request a new Center Account Complete the information requested on the NCTSN Center_Sub-Center Add Change Request Form. • Use the Comment field to indicate which user accounts should have access (Read/Write or View only) to data at the requested Sub-Center • Email to: NCTSN@dcri.duke.edu 56 Version 2.0 Revised 20041018 This form is found in your packet of training materials & on the CD. 56
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