eClinical eCRF Guideline S. Bennett 16MAY2017

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eClinical eCRF Guideline

eClinical eCRF Guideline S. Bennett 16MAY2017

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Table of Contents

“The Basics” ...................................................................................................................... 3

Getting Started .................................................................................................................. 3

Logging In .......................................................................................................................... 3

Accessing Folders .............................................................................................................. 4

Navigating through Data Review/Capture ..................................................................... 7

Creating a Patient ............................................................................................................. 8

Entering Data .................................................................................................................. 10

Randomizing a Subject ................................................................................................... 12

Entering Data into Zones and Logs ............................................................................... 15

Adding an Event (Premature Withdrawal/Unscheduled) ........................................... 21

Applying Electronic Signatures ..................................................................................... 24

Query Management ........................................................................................................ 26

Exiting and Logging Out ................................................................................................ 28

eClinical eCRF Guideline S. Bennett 16MAY2017

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“The Basics”

Getting Started 1. Hardware: must be a PC - not compatible with a Macintosh 2. Internet Explorer 8.0 or greater up to version 11.0– not compatible

with Microsoft Edge , Netscape, Firefox, Chrome, Safari, etc. 3. Must turn off Internet Explorer compatibility view 4. Pop–up Blocker: must be turned OFF 5. Adobe Acrobat 5.0 or greater 6. Screen resolution set to 1024 x 768 or greater 7. The Clinical Trials Management System (CTMS) is unavailable on

Sunday between the hours of 8:00 a.m. and 12:00 noon (Eastern Time)

Logging In

https://trials.ctcc.rochester.edu

1. Enter Login 2. Enter password 3. Click Sign In

eClinical eCRF Guideline S. Bennett 16MAY2017

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Accessing Folders 1. Click on the protocol in the Study Map portlet

eClinical eCRF Guideline S. Bennett 16MAY2017

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2. Click on the folder that contains the documents you wish to access

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3. Use the “Go Back” link to return to the folder list

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Navigating through Data Review/Capture 1. Select the protocol from the Study Map portlet 2. Select Data Review/Capture from the EDC Functions List portlet

eClinical eCRF Guideline S. Bennett 16MAY2017

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3. Click on your center

Creating a Patient

1. Click the Add Patient icon

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2. Enter Patient ID 3. Enter Initials 4. Select Save Changes

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Entering Data

1. Click on the Patient ID

2. Click on the Event

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3. Click on the Page

4. Enter the Evaluation Date (either manually or with calendar widget) 5. TAB to open bottom module 6. Enter data 7. Save Page when finished

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Randomizing a Subject

1. Select the Random Event

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2. Complete the Randomize Page 3. Tab into the Visit Schedule to populate the dates 4. Save Page

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5. To print the Visit Schedule click on Select Action 6. Click on CRF Report

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Entering Data into Zones and Logs

1. Select the SC (Screen) Event 2. Select the MHXGEN (General Medical History) Page 3. Enter the date 4. Press TAB 5. Enter “History” 6. Enter “Description 7. Enter “Status of Symptom” 8. Enter “Year of Diagnosis”

9. Press TAB to add additional history to that category or place cursor in the next

category 10. Follow steps 5-9 to complete Medical History categories

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11. To add a new row to a category, click the plus (+) sign

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12. Click on the drop down arrow for the new row and select the appropriate

category

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13. Click OK 14. Enter data for new row and any remaining categories and click Save Page

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15. In the Navigation Panel

a. Click on LOG b. Click on AE

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16. Enter Investigator Staff Code 17. Press TAB 18. Enter AE 19. Enter Start Date (either manually or with calendar widget) 20. Enter Start Date Estimate (use drop down box) 21. Enter Stop Date as appropriate (either manually or with calendar widget) 22. Enter Stop Date Estimate as appropriate (use drop down box)

23. Complete the rest of the record by tabbing through the fields

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Adding an Event (Premature Withdrawal/Unscheduled)

1. Click on the paper ( ) icon

2. Click on the drop down arrow 3. Click the event to be added

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4. Click Save Changes

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5. Event is added at the end of the list

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Applying Electronic Signatures

1. Click the appropriate box

2. Save Page

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3. Enter Password 4. Click Save Changes

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Query Management

1. Click the Select Action drop down list 2. Click Query Management

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3. Click on Query ID to open query

4. Resolve the query by:

a. Entering a New Value (changing current value in database) i. Enter response in New Value field

ii. Provide Reason for Change iii. Click Save

b. Force Close (leaving current value in the database) i. Enter documentation in Force Reason field

ii. Click Save

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Exiting and Logging Out

1. Click on ‘Exit’ from any page

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2. Click Yes

3. Click on ‘Sign Out’

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4. You will be back at the Login screen