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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Page Count: 56

Version 2.0 Revised 20041018

NCTSN Core Data Set

Reference Manual

Version 2.0 Revised 20041018

Table of Contents

22Enroll a client

21Log-out

15Help!

14NCTSN-InForm Home page

11Passwords

10Screen layout

9Access and Log-in

8Browser basics

7Security features

6System requirements

5System overview

4Glossary

Page NumberTopic

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Table of Contents

Printing

New User Accounts

New Center Sub-Center Accounts

51Reports

50Exports (Listings)

49Admin

48New follow-up visit form

44Comments

42Audit Trail

36Queries

28Navigate through InForm

24Enter, edit & save data

Page NumberTopic

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Glossary of InForm Terminology

Return

Go back to the previous screen

Submit

Save data in the database

Patient

Client/child who is or will be enrolled in

the Core Data Set

Listings

Files of client data for review & interim

analysis

Reports

Client level summaries of standard

assessment scores

Case Report/Record Form (CRF)

Paper version of a data collection form

eCRF

Electronic data collection form/screen

Case Book/Case Record Book

(CRB)

Complete set of all data collection

forms or screens

Enroll

Create a case book for a client/patient

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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

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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

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.

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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

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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)

–4ways 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

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Access & Log-in

4. Click “Log In”

1. Type the Web Address/URL

1. Type the Web Address/URL 2. Type User Name

(Case-Sensitive)

2. Type User Name

(Case-Sensitive)

3. Type default Password

(Case-Sensitive)

3. Type default Password

(Case-Sensitive)

4. Click Log In

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.

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InForm Screen Layout

Navigation

Pane Content Pane

Content-Specific Pane

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Passwords

• 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.

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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.

•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 ****

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“At Will” Password Change

Use the NCTSN Logo on the

Home Page to change your

password if necessary.

1. Click the NCTSN logo

2. Enter your old password

3. Enter your new password

4. 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

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NCTSN Home Page

The HOME button takes you

to the NCTSN Core Data Set

Homepage

NCTSN@DCRI.DUKE.EDU

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HELP!

If you have questions regarding the

InForm system, use InForm’s HELP

functionality to find your answers.

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

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HELP!

Find topics using the “Table of Contents” view or the

“Index” view.

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HELP

Table of Contents View Index View

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Hover Help

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.

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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.

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HELP with NCTSN-specifics

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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.

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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.

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

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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.

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

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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

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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)

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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

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Submit = Save

• Microsoft sends a

confirmation message that

lets you know the data

reached the database

successfully

• Click OK to continue

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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.

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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

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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.

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

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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)

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

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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

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)

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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.

Use the Return button in InForm; do not use the Back button on your

Browser toolbar.

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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.

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Data Validation

Users are alerted

immediately to data

format discrepancies

Users are alerted

immediately to data

format discrepancies

•Prevents data submission until data are corrected

•Ensures data format is correct

Numbers vs. Characters

Decimal requirements

Valid Ranges

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Queries

3 ways to know you have a query:

– Red traffic lights

– Red data fields

– Yellow flag

Queries are “Questions about the data”.

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

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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.

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

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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.

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Answering Queries

Autoquery fires: “Number of children living

in child’s home is fewer than number of

Types of adults living with the child. Please

clarify.”

Clinician enters 3 for “Number of adults living in child’s

home” but indicates that 4 types of adults live with the child.

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

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Answering Queries

5, 6

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.

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Answering Queries

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

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Audit Trail

Documents all activities with the data

– Creating

– Deleting

– Modifying Item Has Been

Changed -- Click to

View Audit Trail

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.

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Audit Trail

SiteUser

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.

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Comments

• 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

Comments are like “electronic post-it notes”

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.

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Comments

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.

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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.

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Dynamic Forms

– Are created upon data submission; Triggered by answers to certain

questions

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

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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 drop-

down box to see list of follow-

up visits.

Note: Additional pages/screens for the Follow up assessment are created when the

data on the initial form has been submitted.

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Admin

• ADMIN button provides

information about the version

of InForm you are using

This is an informational screen. It’s View Only.

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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

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.

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NCTSN Reports

• Custom reports available

– Scores for the standard

assessments

•CBCL

• TSCC-A (Briere)

•PTSD

1. Click REPORTS in the Navigation Pane

2. 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.

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Printing from InForm

•eCRF’s and Reports may be

printed

– Click the “Print Preview”

button

– Then click the Printer icon

on your Browser Toolbar

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Microsoft NCTSN CDS Reference Manual Version 2.0 Revised 20042018 BLACKBERRY ID SWD 1590032 0505111339 001 Vers2.0

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