Jan 29, 2010 ... Oracle Clinical. Remote Data Capture 4.5.3. Site Training Exercises. The
following topics will be covered in a series of exercises: Logged-in as ...
Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Oracle Clinical Remote Data Capture 4.5.3 Site Training Exercises
The following topics will be covered in a series of exercises: Logged-in as a study coordinator: Exercise 1: Exercise 2: Exercise 3: Exercise 4: Exercise 5: Exercise 6: Exercise 7: Exercise 8:
Logging in, Navigation and patient selection Basic Data Entry Discrepancy Management and Validation Discrepancy resolution/modifying data Mark/Unmark a page as blank and Adding Additional Visit Pages Viewing the Audit trail Creating an Investigator comment Logging Out
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC)
Exercise 1: Logging in, Navigation and Patient Selection •
Navigate to the assigned website provided by your trainer.
ENSURE THAT YOU SELECT THE CORRECT STUDY AND SITE NUMBER AS PROVIDED TO YOU
Use the drop-down boxes provided to select the desired study/site and click GO
Task 1: Opening case book for assigned patient 1) Navigate to the Patient Search area.
2) 3) 4) 5) 6)
Use the + sign to expand the Patient Search section. Enter your assigned subject number in the first Range field. Click Go. Place a checkmark in the box to the left of the desired patient number. Click Go.
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC)
Exercise 2: Basic Data Entry Task 1: Complete the Inclusion Criteria page 1) Click the Visit drop-down list. 2) Select the VISIT 1 visit.
3) Click the Inclusion page icon. 4) Click Yes to display secure and non-secure items, if necessary. (HINT: always click yes to this message.) 5) Maximize the eCRF page. 6) Click in the data entry fields on the page using your MOUSE and enter the following data: Data Field Question 1 Question 2 Question 3 Question 4 Question 5 Question 6 Question 7 Question 8
Data to be entered YES YES YES YES YES YES YES YES
You can also use the Tab key to navigate from field to field and the space bar to check any checkboxes. 7) Click the SAVE icon. 8) Click OK. 9) Click the NEXT CRF option in the top right hand corner of the screen.
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Task 2: Complete the Exclusion Criteria page 1) Enter the data in the Exclusion eCRF as per the table below: Data Field Question 1 Question 2 Question 3 Question 4 Question 5 Question 6 Question 7 Question 8
Data to be entered NO NO NO NO NO NO NO NO
2) Click the SAVE icon. 3) Click OK. 4) Click the red X in the top right hand corner of the screen.
5) Click the Refresh button to update the Casebook Spreadsheet view.
NB: DO NOT USE THE REFRESH BUTTON ON THE BROWSER
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC)
Exercise 3: Discrepancy Management and Validation Task 1: Complete the Vitals page – Discrepancy occurs during capture 1) Click the Vitals page icon. (VISIT 1) 2) Enter the data in the Vitals eCRF as per the table below: Data Field Vital Signs Date Time Blood pressure (systolic)
Data to be entered 25JAN2008 12:00 185
3) Press the Tab key. 4) Click OK to accept the discrepancy.
Whenever we see RED fields, this tells us that there is a discrepancy associated with that data field. 5) Continue entering the data in the Vitals eCRF as per the table below: Data Field Blood pressure (diastolic) Pulse Respirations Temperature Weight Height 6) 7) 8) 9)
Data to be entered 90 50 15 37 (check the C box) 120 165 (check the CM box)
Click the SAVE icon. Click OK. Click the red X in the top right hand corner of the screen. Click the Refresh button to update the Casebook Spreadsheet view.
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Task 2: Complete the Med History page – Discrepancy occurs during save 1) Click the MED HIST page icon. 2) Enter the data in the MED HIST eCRF as per the table below: Data Field Date started Date stopped Ongoing check if yes
Data to be entered 30OCT1996 Check this box
3) Click the SAVE icon. 4) Click OK.
5) Click the red X in the top right hand corner of the screen. 6) Click the Refresh button to update the Casebook Spreadsheet view.
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Task 3: Complete the Con Med and Adverse Event pages – Discrepancy occurs after validation 1) 2) 3) 4)
Click the Visit drop-down list. Select the ADVERSE EVENTS visit. Click the Ae Yn page icon. Enter the data in the Ae Yn eCRF as per the table below:
Data Field Has the patient experienced any Adverse Events… 5) 6) 7) 8)
Data to be entered Yes
Click the Save icon. Click OK. Click the NEXT CRF option in the top right hand corner of the screen. Enter the data in the Ae Data eCRF as per the table below:
Data Field Adverse event Start date Stop date Frequency Outcome Any treatment required Intensity Action taken with study drug Relation to study drug Was subject terminated from study due to this AE? Was event serious?
Data to be entered Headache 07DEC2007 Intermittent Recovering/resolving Concomitant medications Mild No action taken Not related No No
9) Click the Save icon. 10) Click OK. 11) Click the red X in the top right hand corner of the screen. 12) Click the Refresh button to update the Casebook Spreadsheet view. 13) Click the Visit drop down list. 14) Select the CON MEDS visit. 15) Click the Con Med Yn page icon. 16) Enter the data in the Con Med Yn eCRF as per the table below: Data Field Were there any concomitant medications taken by the subject prior to screening and /or during the study?
Data to be entered No
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) 17) Click the Save icon. 18) Click OK. 19) Click the red X in the top right hand corner of the screen. 20) Click the Refresh button to update the Casebook Spreadsheet view.
Task 4: Validate patient data 1) 2) 3) 4) 5) 6)
Place a checkmark in the box to the left of the patient number. Click the Select Patients and... drop-down list. Select Validate. Click Go. Click Continue. Click Close.
Running the validation process may identify additional discrepancies/inconsistencies in the data you have entered.
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC)
Exercise 4: Discrepancy resolution/modifying data Task 1: Address the discrepancy on the Ae Data page and revalidate 1) 2) 3) 4)
Click the Visit drop down-list. Select the ADVERSE EVENTS visit. Click the Ae Data page icon. Click the CRF Navigator button to the right of the eCRF to expand the Navigator Pane.
CRF Navigator button
5) Select the “Multi” discrepancy under the List heading (marked with a red dot). 6) Review the Description of the discrepancy in the Details section. NB: The Related Values button displays details of related eCRF pages.
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) 7) Make a change to the “Any treatment required?” data field: Data Field Any treatment required?
Data to be entered None
The Reason for Change box appears because you have made a change to a previously saved page.
8) Select “Data Entry Error” from the Reason drop-down list.
9) Click OK. 10) Click the SAVE icon. 11) Click OK. 12) Click the red X in the top right hand corner of the screen. The red field disappears; however, you must run a second Validate process in order to update all fields associated with this discrepancy. 13) Place a checkmark in the box to the left of the patient number. 14) Click the Select Patients and... drop-down list. 15) Select Validate. 16) Click Go. 17) Click Continue. 18) Click Close. The Ae Data page icon is now white indicating the discrepancy has been resolved.
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Task 2: Address the discrepancy on the VITALS page 1) 2) 3) 4) 5)
Click the Visit drop down-list. Select the VISIT 1 visit. Click the VITALS page icon. Expand the CRF Navigator Pane, if necessary. Select the “Systolic Blood pressure in mmHg” discrepancy under the List heading. 6) Review the Description of the discrepancy in the Details section. 7) Select Send to CRA in the Action drop-down list. 8) Click Go. 9) Add the following in the Comment section: “Blood pressure is correct, value was 185. Investigator considered this non-significant”. 10) Click OK. 11) Click the SAVE icon. 12) Click OK. 13) Click the red X in the top right hand corner of the screen. 14) Click the Refresh button to update the Casebook Spreadsheet view.
The field and page are now yellow, which indicates that the discrepancy is actionable to another group, e.g. CRA.
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC)
Task 3: Address the discrepancy on the MED HIST page
1) 2) 3) 4) 5)
Click the MED HIST page icon. (VISIT 1) Expand the CRF Navigator Pane, if necessary. Select the “Multi” discrepancy under the List heading. Review the Description of the discrepancy in the Details section. Add the following data to this CRF as per table below:
Data Field Condition/Diagnosis 6) 7) 8) 9)
Data to be entered Rash
Click the SAVE icon. Click OK. Click the red X in the top right hand corner of the screen. Click the Refresh button to update the Casebook Spreadsheet view.
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC)
Exercise 5: Marking/Unmarking a Page as Blank and Adding Additional Visit Pages Task 1: Marking a Page as Blank 1) 2) 3) 4)
Click the Visit drop down list. Select the VISIT 2 visit. Click the VITALS page icon. Click on the Blank Flag Tool button.
If you are unsure which button to select, hover your mouse over the buttons to display their names.
5) Place a checkmark in the Mark Section Vit (1) box. 6) Click OK. 7) Click the SAVE icon. 8) Click OK. 9) Click the red X in the top right hand corner of the screen. 10) Click the Refresh button to update the Casebook Spreadsheet view.
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Task 2: Unmarking a Page as Blank 1) Click the VITALS page icon. 2) Un-check the Check if Entire Page Blank check box.
3) Select Data Entry Error as reason in the Reason for Change box. 4) Click OK. 5) Enter the data in the VITALS eCRF as per the table below: Data Field Vital Signs Date Time Blood pressure (systolic) Blood pressure (diastolic) Pulse Respirations Temperature Weight Height 6) 7) 8) 9)
Data to be entered 01FEB2008 12:00 120 80 50 15 37 (check the C box) 120 165 (check the CM box)
Click Save. Click OK. Click the red X in the top right hand corner of the screen. Click the Refresh button to update the Casebook Spreadsheet view.
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Task 3: Adding Additional Visit Pages 1) Click the Visit drop-down list. 2) Select the ADVERSE EVENTS visit. 3) Place a checkmark in the box to the left of the patient number. 4) Click the Add Visit Page button.
5) Click the radio button for the Ae Data page. 6) Click Continue. 7) Leave all default values and click the Apply button A new Unplanned Visit Page is added to the Casebook Spreadsheet. 8) Click on the new Ae Data page icon. 9) Enter the data on the Ae Data page as per the table below: Data Field Adverse event Start date Stop date Frequency Outcome Any treatment required Intensity Action taken with study drug Relation to study drug Was subject terminated from study due to this AE? Was event serious?
Data to be entered Urticaria 30DEC2007 03FEB2008 Continuous Recovered/Resolved None Moderate Stopped Temporarily Not related No No
10) Click the SAVE icon. 11) Click OK. 12) Click the red X in the top right hand corner of the screen. 13) Click the Refresh button to update the Casebook Spreadsheet view.
OC RDC 4.5.3. Site Training Exercises V1.3 January 29, 2010 PPD Proprietary
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC)
Exercise 6: Viewing the audit trail 1) 2) 3) 4) 5)
Click the Visit drop-down list. Select the VISIT 1 visit. Click the Med Hist page icon. Click the Highlight drop-down list. Select Audit History.
6) Expand the Audit History Pane. Open Audit History
7) Click in the Condition/Diagnosis box 8) View the changes made to the field by viewing the details in the Audit History pane. 9) Click the Details icon (on the right). 10) Click Close. 11) Click the red X in the top right hand corner of the screen.
The details icon provides a different view of the same information shown in the audit history pane and allows you to easily read a lengthy comment.
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Oracle® Clinical Remote Data Capture 4.5.3 HTML (OC RDC)
Exercise 7: Creating an Investigator Comment 1) Click the Vitals page icon. (VISIT 1) 2) Click on the Systolic Blood Pressure field (value=185). 3) Click the Investigator Comment icon
4) Add the following to the Investigator Comment field: a. Per Investigator, not clinically significant.
5) 6) 7) 8)
Click OK. Click the Save icon. Click OK. Click the red X in the top right hand corner of the screen.
Exercise 8: Logging Out
1) Click the Logout link at the top of the screen. 2) Close all open windows.
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