OpenClinica Training Exercises for Data Managers

Transcription

1 OpenClinica 3.1 for CTC Studies OpenClinica Training Exercises for Data Managers Version May 2013 Page 1 of 41

2 Contents EXERCISE LOGGING ON... 3 EXERCISE THE SUBJECT MATRIX BROWSING DATA... 5 EXERCISE PRINTING AN ECRF EXERCISE ONLINE HELP (OPENCLINICA REFERENCE GUIDE) EXERCISE ENTER DATA FOR A REGULAR FORM EXERCISE MARK AN EVENT AS COMPLETE EXERCISE DISCREPANCY NOTES AND MISSING DATA EXERCISE ENTER DATA FOR A REPEATING FORM SECTION EXERCISE EDIT DATA EXERCISE ENTER DATA FOR A REPEATING EVENT (SAE) AND VIEW INSTANCES OF A REPEATING EVENT EXERCISE FAILED VALIDATION CHECKS EXERCISE FIND AND REVIEW A QUERY EXERCISE ANSWER A QUERY DATA VALUE NOT CHANGED EXERCISE ANSWER A QUERY DATA VALUE NEEDS TO BE CHANGED EXERCISE CREATE A NEW THREAD EXERCISE LOGGING OUT EXERCISE RESETTING A FORGOTTEN PASSWORD Page 2 of 41

3 Exercise 1. Logging on Log in to the OpenClinica Training database, by going to: then scroll to the bottom of the dropdown list and select Training, then select OpenClinica generic training system. The OpenClinica Login Screen will be displayed. 1. Enter your User Name: (provided via from the Coordinating Centre) 2. Enter your Password: (provided via from the Coordinating Centre). 3. Reset your password and set your challenge question and answer Remember both your password challenge question and answer you will need them if you forget your password. About passwords User Names and Passwords are case sensitive Page 3 of 41

4 Passwords must be 8 characters in length and consist of at least 1 number Passwords must be changed every 90 days Passwords cannot be reused Passwords in an ecrf system are equivalent to your written signature Passwords must never be shared Whenever you log on using a centrally issued password you will be required to change your password i.e. centrally supplied passwords only allow the user to log onto the system to change their password. Page 4 of 41

5 Exercise 2. The Subject Matrix Browsing Data 1. Use the subject matrix to browse through a subject s record for data already entered for the training study: Module A, pages 17, a. From the Subject Matrix page, click on the View icon (magnifying glass) at the far right of any patient that has data (i.e. icons are not all blue) b. From the View Subject page, click on the View icon next to any ecrf Page 5 of 41

6 c. Click through the ecrf sections to view the data d. Click Exit to get back to the View Subject page e. Click Subject Matrix button in the navigation bar, or Go Back to Subject List at the bottom of the page, to get back to the Subject Matrix page Page 6 of 41

7 2. Practice drilling down from the Subject Matrix to specific events, then browsing through the ecrfs for that event, pages 17, a. Click on any Event that has data (i.e. icon is not blue) b. Click View/Enter data in the pop-up menu c. Click on the View icon next to any ecrf d. Click through the ecrf sections to view the data e. Click Exit to get back to the View Subject page f. Click Subject Matrix button in the navigation bar, or Go Back to Subject List at the bottom of the page, to get back to the Subject Matrix page Page 7 of 41

8 3. Try using the Filters in the Subject Matrix: Module A, page 17 a. In the grey box below the Study Subject ID, type in a study subject ID for any patient in the list b. Click Apply Filter at the far right (or alternatively, press the Enter key of your keyboard) c. Click Clear Filter (at the far right) to clear the filter d. For any event, click the grey box and select Completed e. Click Clear Filter (at the far right) to clear the filter Page 8 of 41

9 4. Try using the View by Event tools in the Subject Matrix: Module A, page 19 a. In the Select an Event dropdown menu, select Surgery/Pathology b. Click on the ALC_PATH form for any patient, then select View from the pop-up menu c. Click Exit to get back to the Subject Matrix page Page 9 of 41

10 Exercise 3. Printing an ecrf 1. Try printing an ecrf: Module A, page 24 a. In the Subject Matrix, click on any Event that has data (i.e. icon is not blue) b. Click View/Enter data in the pop-up menu c. Click on the Print icon next to any ecrf (on the far right of the screen) d. Use the print button in the File menu to print the ecrf e. Close the print preview window Page 10 of 41

11 Exercise 4. Online Help (OpenClinica Reference Guide) 1. Access OpenClinica online help: Module A, page 25 a. Click on the help icon (question mark) next to the heading at the top of any age b. Briefly review the help available using the expandable menus at the left of the OpenClinica Reference Guide which appears in a new window c. Close the OpenClinica Reference Guide window Page 11 of 41

12 Exercise 5. Enter Data for a Regular Form Try Data Entry for a Regular Form: Module B, pages 4-16: For the patient number assigned to you in the from CTC: 1. Schedule the Baseline event a. Clicking on the baseline event in the Subject Matrix for your patient b. Click Schedule c. Enter the Start Date as 13-Apr-2010 (leave the time and end date/time blank) d. Click Proceed to Enter Data Page 12 of 41

13 2. Enter data for a regular Form a. Click the Enter Data icon (pencil) to the right of the ALC_BASE ecrf b. Enter the following data: NB: try using the calendar to enter the date item otherwise use the identical format you see here including upper and lower case, or you will get an error message that the date is in the wrong format c. Click Save NB: there is a save button at the top and bottom of each page - you can use either save button OpenClinica will automatically navigate to the next section Page 13 of 41

14 d. On the next section, enter the following data NB: this screen uses show/hide dynamic items the child items will appear based on the parent item values. e. Click Save Page 14 of 41

15 f. On the next section, enter the following data g. Tick the Mark CRF complete box h. Click OK for the warning message about marking the CRF complete i. Click Save You should be returned to the Enter or Validate Data for CRFs in Baseline page and see a green tick for the ALC_BASE NB: note that the CRFs change order once data has saved, so that forms not started are at the top of the list. Remember a green tick only means that you have marked the CRF complete not that the data is complete or without queries Page 15 of 41

16 3. Try entering data for the CTC_CADATA ecrf a. Click the Enter Data icon (pencil) to the right of the CTC_CADATA ecrf b. Enter the following data: NB: leave the (CTC staff only) fields blank c. Tick the Mark CRF complete box d. Click OK for the warning message about marking the CRF complete e. Click Save You should be returned to the Enter or Validate Data for CRFs in Baseline page and see a green ticks for both the ALC_BASE and CTC_CADATA CRFs. Page 16 of 41

17 Exercise 6. Mark an Event as Complete Because you entered in the baseline CRF that this patient will not be completing the QoL for this study, the remainder of the CRFs in the baseline event (QOL_PTDATA and QOL_ HADS) do not need to be completed for this patient. Check the event status there are 2 ways to do this: 1. In the Enter or Validate Data for CRFs in Baseline page, look at the Subject Event Status in the box at the top of the page. It should say data entry started OR 2. Navigate to the Subject Matrix (click Exit from the Enter or Validate Data for CRFs in Baseline page, or click on the Subject Matrix button in the navigation menu at the top of the page) The Baseline Event icon for your patient should be yellow = data entry started Page 17 of 41

18 However, the event is actually complete, because no further CRFs in this event are applicable for this patient. 3. To mark the event as completed: Module B, page 19 a. Click on the baseline event in the Subject Matrix b. Click View/Enter data in the pop-up menu c. In the Enter or Validate Data for CRFs in Baseline page, click Edit Study Event at the top of the event summary Page 18 of 41

19 d. In the Update Study Event screen, select a status of Completed e. Click Submit Changes NB: Completed will only appear as an option if all of the started CRFs in the event are marked as complete. f. Check that the event status is now completed in the Subject Matrix Question: If you marked an event as complete, but then realised that you hadn t finished data entry in it, how can you easily find it to complete the data entry? Answer: You can t easily find it. Therefore, only mark Events as Complete when you are certain that all required data entry is completed. Page 19 of 41

20 Exercise 7. Discrepancy notes and missing data For the patient number assigned to you in the from CTC: 1. Schedule the 30 Day Event a. Clicking on the 30 Day event in the Subject Matrix for your patient b. Click Schedule c. Enter the Start Date as 20-May-2010 (leave the time and end date/time blank) d. Click Proceed to Enter Data 2. In the ALC_EARLYAE CRF, enter the following incomplete data: a. Click the Enter Data icon (pencil) to the right of the ALC_EARLYAE ecrf b. Enter the following data in the PERIOP section: c. Click save Page 20 of 41

21 You will receive 3 [Missing data in required field] errors at the top of the screen: And the items that are missing will be marked in red with an exclamation mark: 2. Assume that the length of hospital stay is unknown, and will never be known. To deal with missing data that will never be completed, add an Annotation type discrepancy note: Module B, page 26 a. Click on the query flag to the right of length of hospital stay b. Enter the Description, including unknown not in medical record c. Leave the Detailed Note unchanged this will help you to find it later d. Type: choose Annotation e. Set to Status: leave this as Not Applicable f. Click [Submit] g. Note that the discrepancy note will not be saved until the form is saved h. Click Close Page 21 of 41

22 3. Assume that the number of days in ICU is not currently available, but is expected to be available later. To deal with missing data that will be completed later, add a Failed Validation Check type discrepancy note: Module B, page 27 a. Enter the Description: Data pending from ICU b. Detailed Note: leave this unchanged this will help you to find it later c. Type: leave this as Failed validation check d. Set to Status: leave this as New e. Click [Submit]. f. Note that the discrepancy note will not be saved until the form is saved g. Click Close 4. Assume that was re-operation necessary was accidentally not completed. To deal with missing data that is known, simply complete the missing data: a. Select No 5. Once you have resolved all of the errors, you will be able to save the form: a. Click Save OpenClinica will automatically go to the next section. 6. Click back to the PERIOP form and review the colour of the flags next to the previously missing items: a. Length of hospital stay: white flag no action required b. Days in ICU: red flag resolution required c. Was re-operation necessary: blue flag no discrepancy notes exist Page 22 of 41

23 Exercise 8. Enter Data for a Repeating form section Try Data Entry for a Repeating Section: Module B, page 22: 1. Continuing on from the CRF started in the previous exercise, in the ALC_EARLYAE CRF, enter the following data: a. Click the Enter Data icon (pencil) to the right of the ALC_EARLYAE ecrf b. Enter the following data in the EARLYAE section (which is NOT repeating): c. Click save Page 23 of 41

24 d. In the OTHEREARLYAE section (which is a repeating form section): e. Enter the following data: NB: use the Add button to add extra rows f. Tick the Mark CRF complete box g. Click OK for the warning message about marking the CRF complete h. Click Save Page 24 of 41

25 Exercise 9. Edit Data Try Editing Data: Module B, pages For the patient number assigned to you in the from CTC: 1. In the ALC_EARLYAE CRF, in the PERIOP section: a. Revise the date of assessment from 20-May-2010 to 21-May-2010 b. Click Save You will receive an error message at the top of the screen: And the item that has been changed will be marked in red with an exclamation mark: 2. Add a Reason for Change Discrepancy Note: a. Enter Description: transcription error b. Detailed Note leave this unchanged c. Type: select Reason for Change (if not already) d. Set to Status: leave this as Not Applicable e. Click [Submit & Close]. f. Click Save Page 25 of 41

26 Exercise 10. Enter Data for a Repeating Event (SAE) and View Instances of a Repeating Event Try Data Entry for a Repeating Event: Module B, page 33: For the patient number assigned to you in the from CTC: 1. Schedule an SAE event a. Clicking on the SAE event in the Subject Matrix for your patient b. Click Schedule c. Enter the Start Date as 29-Apr-2010 (leave the time and end date/time blank) d. Click Proceed to Enter Data 2. Enter data for the SAE form a. Click the Enter Data icon (pencil) to the right of the ALC_SAE CRF b. (To save time, do not enter data exit the form) Page 26 of 41

27 3. Schedule a second SAE event a. Clicking on the SAE event in the Subject Matrix for your patient b. Click Add Another Occurrence c. d. Enter the Start Date as 15-May-2010 (leave the time and end date/time blank) e. Click Proceed to Enter Data 4. Enter data for the SAE form a. Click the Enter Data icon (pencil) to the right of the ALC_SAE CRF b. (To save time, do not enter data exit the form) 5. Review data for both events: a. Click on the Subject Matrix button b. Click on the SAE event c. Click View/Enter for either SAE event occurrences Page 27 of 41

28 Exercise 11. Failed Validation Checks Enter data that will trigger some Failed Validation Checks: For the patient number assigned to you in the from CTC: 1. Schedule the Surgery/Pathology Event a. Clicking on the Surgery/Pathology Event in the Subject Matrix for your patient b. Click Schedule c. Enter the Start Date as 20-Apr-2010 (leave the time and end date/time blank) d. Click Proceed to Enter Data 2. Enter data for the Surgery Form a. Click the Enter Data icon (pencil) to the right of the ALC_SURG CRF b. Enter the following data c. Click Save Page 28 of 41

29 You will receive query message at the top of the screen: And the items that are queried will be marked in red with an exclamation mark: 3. If you know the correct value, you can fix the error without a discrepancy note being created this is called a dry run: Module C, pages 9-10 a. For item S3, revise the value to 20-Apr-2010 b. Click Save OpenClinica will automatically go to the next section. 4. Click back to the SURGDET form and review the colour of the flags next to the previously missing items: a. The item that you corrected ([S3]) has a blue query flag - no discrepancy notes exist b. The items that you did not revise/correct ([S6], [S7], [S8]) all have a red query flag resolution required 5. Complete data entry for the ALC_SURG CRF (otherwise subsequent exercises will not work correctly) a. Section LAPDET: Select Open, click Save b. Section: CONVERSION Select Open, click Save c. Section: INTRAOP: Enter all as No (use N and tab on your keyboard, alternately) d. Section: OTHERINTRAOP: Don t enter any data e. Tick the Mark CRF complete box f. Click OK for the warning message about marking the CRF complete g. Click Save Page 29 of 41

30 Exercise 12. Find and review a query Assume that you will need to come back later to address the queries created in the previous exercise. 1. Try finding the queries in the Notes & Discrepancies page: Module C, pages a. Click on the Notes & Discrepancies button in the navigation bar NB: if you are already in a CRF, exit the CRF to see the Navigation bar 2. Filter by your patient a. Click on the grey rectangle below the Study Subject ID column heading b. Type your patients number c. Click Apply Filter at the far right (or alternatively, press the Enter key of your keyboard) Page 30 of 41

31 3. Filter by Resolution Status New a. Click on the grey rectangle below the Resolution Status column heading b. Select status New 4. View a discrepancy Note a. Click the View icon (magnifying glass) next to the discrepancy note b. Click Exit Window (top right hand corner) to return to the Notes & Discrepancies page 5. View an ecrf containing a discrepancy note a. Click the View within record icon (arrow) next to the discrepancy note b. Click Exit to return to the Notes & Discrepancies page Page 31 of 41

32 Exercise 13. Answer a query data value not changed 1. Assume that the [S6] Open to close operative time was 240 minutes (as previously entered), so the value does not need to be changed, but the query needs to be answered. You will need to propose a resolution to the query: Module C, page 24. From the Notes & Discrepancies page, for the patient number assigned to you in the from CTC: a. Click the View within record icon (arrow) next to the discrepancy note with description [S6] Surgery time is outside the expected range OpenClinica will take you to the ALC_SURG CRF. b. Click on the red query flag next to item [S6] Open to close operative time Page 32 of 41

33 c. Click Propose Resolution d. Enter the Description Original value is correct e. Leave the Detailed Note blank f. Type: leave this as Resolution Proposed g. Click [Submit & Exit] h. Navigate away and then back to the CRF to see that the query flag is now green resolution proposed and awaiting review by CTC Page 33 of 41

34 Exercise 14. Answer a query data value needs to be changed Option 1: propose resolution, then change value 1. Assume that [S7] Total estimated blood loss was incorrectly entered as 800ml and should have been 400ml, so the value needs to be changed and a resolution must be proposed. In this example, propose the resolution first, then revise the value: Module C, page 25. From the Notes & Discrepancies page, for the patient number assigned to you in the from CTC: a. Click the View within record icon (arrow) next to the discrepancy note for [S7] Blood loss is outside the expected range OpenClinica will take you to the ALC_SURG CRF. b. Click on the red query flag next to item [S7] Total estimated blood loss. Page 34 of 41

35 c. Click Propose Resolution d. Enter the Description Changed data per query e. Leave the Detailed Note blank f. Type: leave this as Resolution Proposed g. Click [Submit & Exit] h. Revise the value for [S7] Total estimated blood loss from 800 to 400 i. Click Save NB: if the CRF has not been marked as complete, you will not see the Save button when navigating via the Notes & Discrepancies page j. Navigate back to the SURGDET CRF section to see that the query flag is now green resolution proposed and awaiting review by CTC Page 35 of 41

36 Option 2: change value, then propose resolution 2. Assume that [S8] Final incision length was incorrectly entered as 50.0 and should have been 5.0, so the value needs to be changed and a resolution must be proposed: in this example, change the value first, then propose the resolution: Module C, page 26. From the Notes & Discrepancies page, for the patient number assigned to you in the from CTC: a. Click the View within record icon (arrow) next to the discrepancy note for [S8] Incision length is outside the expected range OpenClinica will take you to the ALC_SURG CRF. b. Revise the value for [S8] Final incision length from 50.0 to 5.0 c. Click Save You will receive a You have changed data error message d. Click on the red query flag next to item [S8] Final incision length. Page 36 of 41

37 e. Click Propose Resolution f. Enter the Description Changed data per query g. Leave the Detailed Note blank h. Type: leave this as Resolution Proposed i. Click [Submit & Exit] j. Click Save on the ecrf k. Navigate back to the SURGDET CRF section to see that the query flag is now green resolution proposed and awaiting review by CTC Page 37 of 41

38 Exercise 15. Create a new thread Try adding a new thread to an item that already has a discrepancy note: Module C, page 32 For the patient number assigned to you in the from CTC, try adding a comment that the incision length was only measured to the nearest centimetre: 1. Navigate to the ALC_SURG CRF 1. On the SURGDET tab, add a new comment to item [S8] Final incision length : a. Click the flag next to the item b. Click Begin New Thread c. Enter the Description Incision length was only measured to the nearest centimetre: d. Leave the Detailed Note blank e. Type: choose Annotation f. Set to Status: leave as Not Applicable g. Click [Submit & Exit] Page 38 of 41

39 h. Navigate back to the discrepancy notes for the item (click on the query flag) to see that there are now two threads for this item: one annotation, and one failed validation check. NB: you may sometimes see that multiple lines are entered within a thread for one resolution/closure this is a quirk of OpenClinica, and should not cause any issues. Page 39 of 41

40 Exercise 16. Logging out Page 40 of 41

41 Exercise 17. Resetting a Forgotten Password 1. Click the Forgot Password link 2. Enter your user name 3. Enter your used for the OpenClinica account 4. Select password challenge question. This is the password challenge question that you selected when resetting your password upon logging in the first time 5. Enter the answer to the password challenge. This is the answer that you specified when resetting your password upon logging in the first time 6. Click "Submit Password Request" 7. The system will send a new password only if a correct combination of password challenge and answer are specified. Otherwise, the system will prompt an error message indicating that the password challenge could not be verified. 8. Once a correct password challenge question and answer are provided, the system will send a message to the associated containing the new password. You will use this information to login to OpenClinica. After logging in using the new password, you will be prompted to choose a new password. This is the end of the exercises please advise your CTC trial coordinator that you have completed the exercises, so that your data entry can be checked. Thank You. Page 41 of 41