eclinical ecrf Guideline

Transcription

1 eclinical ecrf Guideline 1

2 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 Randomizing a Subject Entering Data into Zones and Logs Adding an Event (Premature Withdrawal/Unscheduled) Applying Electronic Signatures Query Management Exiting and Logging Out

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

4 Accessing Folders 1. Click on the protocol in the Study Map portlet 4

5 2. Click on the folder that contains the documents you wish to access 5

6 3. Use the Go Back link to return to the folder list 6

7 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 7

8 3. Click on your center Creating a Patient 1. Click the Add Patient icon 8

9 2. Enter Patient ID 3. Enter Initials 4. Select Save Changes 9

10 Entering Data 1. Click on the Patient ID 2. Click on the Event 10

11 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 11

12 Randomizing a Subject 1. Select the Random Event 12

13 2. Complete the Randomize Page 3. Tab into the Visit Schedule to populate the dates 4. Save Page 13

14 5. To print the Visit Schedule click on Select Action 6. Click on CRF Report 14

15 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 15

16 11. To add a new row to a category, click the plus (+) sign 16

17 12. Click on the drop down arrow for the new row and select the appropriate category 17

18 13. Click OK 14. Enter data for new row and any remaining categories and click Save Page 18

19 15. In the Navigation Panel a. Click on LOG b. Click on AE 19

20 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 20

21 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 21

22 4. Click Save Changes 22

23 5. Event is added at the end of the list 23

24 Applying Electronic Signatures 1. Click the appropriate box 2. Save Page 24

25 3. Enter Password 4. Click Save Changes 25

26 Query Management 1. Click the Select Action drop down list 2. Click Query Management 26

27 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 27

28 Exiting and Logging Out 1. Click on Exit from any page 28

29 2. Click Yes 3. Click on Sign Out 29

30 4. You will be back at the Login screen 30