Oracle Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Oracle Clinicalstorage.ppdi.com/edc/html/reference/cra/4.5.3_Project_Team... · (OC RDC) OC RDC 4.5.3 Project Team Training

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OC RDC 4.5.3 Project Team Training Exercises V1.2 January 29, 2010 PPD Proprietary

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Oracle Clinical Remote Data Capture 4.5.3 Project Team Training Exercises The following topics will be covered in a series of exercises: Logged-in as a study coordinator: Exercise S1: Logging in, Navigation and Patient Selection Exercise S2: Basic Data Entry Exercise S3: Discrepancy Management and Validation Exercise S4: Discrepancy resolution/modifying data Exercise S5: Mark/Unmark a page as blank and Adding Additional Visit Pages Exercise S6: Viewing the Audit trail Exercise S7: Creating an Investigator comment Exercise S8: Logging Out Logged-in as the CRA: Exercise C1: Logging in, Navigation and Patient Selection Exercise C2: Resolving discrepancies sent to you by site Exercise C3: Creating a manual field/section discrepancy Exercise C4: Verification of patient data Exercise C5: Viewing an Investigator comment Exercise C6: Logging Out Logged-in as the Principal Investigator: Exercise I1: Logging in, Navigation and Patient Selection Exercise I2: Electronic Approval of Patient Data Exercise I3: Logging Out


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Exercise S1: 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 Casebook for Assigned Patient

1) Navigate to the Patient Search area.

2) Use the + sign to expand the Patient Search section. 3) Enter your assigned subject number in the first Range field. 4) Click Go. 5) Place a checkmark in the box to the left of the desired patient number. 6) Click Go.


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Exercise S2: 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 data

as per the table below: Data point name Data to be entered Question 1 YES Question 2 YES Question 3 YES Question 4 YES Question 5 YES Question 6 YES Question 7 YES Question 8 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.

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Task 2 : Complete the Exclusion Criteria page

1) Enter the data in the Exclusion eCRF as per the table below:

Data point name Data to be entered Question 1 NO Question 2 NO Question 3 NO Question 4 NO Question 5 NO Question 6 NO Question 7 NO Question 8 NO

2) Click the SAVE icon. 3) Click OK. 4) Click the NEXT CRF option in the top right hand corner of the screen.


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Task 3: Complete the Demography Page 1) Enter the data in the Demography page eCRF as per the table below:

Data point name Data to be entered Subject’s initials LVS Date of birth 11OCT1977 Sex Female Race White Ethnicity Not Hispanic or Latino

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


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Exercise S3: Discrepancy Management and Validation

Task 1: Complete the Vitals Page – Discrepancy Occurs During Capture

1) Click the Vitals page icon. 2) Enter the data in the Vitals eCRF as per the table below:

Data point name Data to be entered Vital Signs Date 25JAN2008 Time 12:00 Blood pressure (systolic) 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 point name Data to be entered Blood pressure (diastolic) 90 Pulse 50 Respirations 15 Temperature 37 (check the C box) Weight 252

6) Press the Tab key. 7) Click OK to accept the discrepancy. 8) Continue entering the data in the Vitals eCRF as per the table below:

Data point name Data to be entered Height 165 (check the CM box)

9) Click the SAVE icon. 10) Click OK. 11) Click the red X in the top right hand corner of the screen.



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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 point name Data to be entered Date started 30OCT1996 Date stopped Ongoing check if yes 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.


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Task 3: Complete the Con Med and Adverse Event Pages – Discrepancy Occurs After Validation

1) Click the Visit drop-down list. 2) Select the ADVERSE EVENTS visit. 3) Click the Ae Yn page icon. 4) Enter the data in the Ae Yn eCRF as per the table below:

Data point name Data to be entered Did the patient experience any adverse events……

Yes

5) Click the Save icon. 6) Click OK. 7) Click the NEXT CRF option in the top right hand corner of the screen. 8) Enter the data in the Ae Data eCRF as per the table below:

Data point name Data to be entered Adverse event Headache Start date 28JAN2008 Stop date Frequency Intermittent Outcome Recovering/resolving Any treatment required Concomitant medications Intensity Mild Action taken with study drug No action taken Relation to study drug Not related Was subject terminated from study due to this AE?

No

Was event serious? 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.


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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 point name Data to be entered Were there any concomitant medications taken by the subject prior to screening and /or during the study?

No

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) Place a checkmark in the box to the left of the patient number. 2) Click the Select Patients and... drop-down list. 3) Select Validate. 4) Click GO. 5) Click Continue. 6) Click Close.


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Exercise S4: Discrepancy Resolution/Modifying Data Task 1: Address the Discrepancy on the Ae Data Page and Revalidate

1) Click the Visit drop-down list. 2) Select the ADVERSE EVENTS visit. 3) Click the Ae Data page icon. 4) 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) View the reason for the discrepancy in the Details panel below. 7) Make a change to the “Any treatment required?” data field:

Data point name Data to be entered Any treatment required None


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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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Task 2: Address the discrepancies on the VITALS page

1) Select the VISIT 1 visit from the drop-down list 2) Click the VITALS page icon. 3) Expand the CRF Navigator Pane, if necessary. 4) Select the “Systolic Blood pressure in mmHg” discrepancy under the List

heading. 5) Review the reason for the discrepancy in the Details section. 6) Select Send to CRA in the Action drop-down list.

7) Click Go. 8) Add the following in the Comment section: “Blood pressure is correct, value is

185. Investigator considered this non-significant.” 9) Click OK.


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10) Select the “Weight” discrepancy under the List heading. 11) Review the reason for the discrepancy in the Details section. 12) Select Send to CRA in the Action drop-down list. 13) Click Go. 14) Add the following in the Comment section: “Originally typed incorrect weight.

Corrected weight to 252 and discrepancy appeared. Please advise.” 15) Click OK. 16) Click the SAVE icon. 17) Click OK. 18) Click the red X in the top right hand corner of the screen. 19) Click the Refresh button to update the Casebook Spreadsheet view.

The fields and pages are now yellow, which indicates that the discrepancy is actionable to another group, e.g. CRA

Task 3: Address the discrepancy on the MED HIST page

1) Click the MED HIST page icon. (VISIT 1) 2) Expand the CRF Navigator Pane, if necessary. 3) Select the “Multi” discrepancy under the List heading. 4) Review the Description of the discrepancy in the Details section. 5) Add the following data to this CRF as per table below:

Data Field Data to be entered Condition/Diagnosis Rash

6) Click the SAVE icon. 7) Click OK. 8) Click the red X in the top right hand corner of the screen. 9) Click the Refresh button to update the Casebook Spreadsheet view.



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Exercise S5: Marking/Unmarking a Page as Blank and Adding Additional Visit Pages Task 1: Marking a Page as Blank

1) Click the Visit drop-down list. 2) Select the VISIT 2 visit. 3) Click the VITALS page icon. 4) 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.

Task 2: Unmarking a Page as Blank

1) Click the VITALS page icon. 2) Un-check the “Check if Entire Page Blank” check box on the eCRF. 3) Select Data Entry Error from the Reason for Change box 4) Click OK. 5) Enter the data in the VITALS eCRF as per the table below:

Data point name Data to be entered Vital Signs Date 01FEB2008




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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.

8) Click on the new Ae Data.1 page icon. 9) Enter the data on the Ae Data.1 page as per the table below:

Data point name Data to be entered Adverse event Urticaria Start date 28JAN2008 Stop date 10FEB2008 Frequency Continuous Outcome Recovered/Resolved Any treatment required None Intensity Moderate Action taken with study drug Stopped Temporarily Relation to study drug Not related Was subject terminated from study due to this AE?

No

Was event serious? No



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Exercise S6: Viewing the audit trail

1) Click the Visit drop-down list. 2) Select the VISIT 1 visit. 3) Click the Med Hist page icon. 4) Click the Highlight drop-down list. 5) 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).

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.

10) Click Close. 11) Click the red X in the top right hand corner of the screen.



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Exercise S7: Creating an Investigator Comment

1) Click the Visit drop-down list. 2) Select the VISIT 1 visit. 3) Click the Vitals page icon. 4) Click on the Systolic Blood Pressure field (value=185). 5) Click the Investigator Comment icon.

6) Add the following to the Investigator Comment field:

a. Per Investigator, not clinically significant. 7) Click OK. 8) Click the Save icon. 9) Click OK. 10) Click the red X in the top right hand corner of the screen.

Exercise S8: Logging Out

1) Click the Logout link at the top of the screen. 2) Close any open windows.


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Exercise C1: Logging in, Navigation and Patient Selection

• Navigate to the assigned website provided by your trainer. • Login using the CRA credentials provided by your trainer. • Select the CORRECT study and site. Exercise C2: Resolving discrepancies sent to you by site Task 1: Opening case book for assigned patient

1) Navigate to the Patient Search area.

2) Use the + sign to expand the Patient Search section. 3) Enter your assigned subject number in the first Range field. 4) Click Go. 5) Place a checkmark in the box to the left of the desired patient number. 6) Click Go.


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Task 2: Resolving discrepancies – Sending them back to site

1) Select the VISIT 1 visit from the Visit drop-down box. 2) Click the VITALS page icon. 3) Click the CRF Navigator button to the right of the eCRF to expand the

Navigator Pane.

CRF Navigator button

4) Select the “Systolic blood pressure in mmHg” discrepancy under the List

heading (marked with a red dot). 5) View the reason for the discrepancy and the comment in the Details panel

below. 6) Select Send to Investigator in the Action drop-down list. 7) Click Go. 8) Highlight the original comment that is currently in the Comment (optional) field

and type your response to the comment in this field. Add the following in the Comment section “Per the protocol, the blood pressure must remain within the acceptable limits specified or the subject must be removed from the study.”

9) Click OK.

To view the discrepancy history which includes the original comment from the site user, click the History button within the Navigation Pane.



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Task 3: Resolving discrepancies – Closure

1) Select the “Weight” discrepancy under the List heading (marked with a red dot).

2) View the reason for the discrepancy in the Details panel below. 3) Select Close – resolved in the Action drop-down list. 4) Click Go. 5) Click the Resolution Reason drop-down list. 6) Select No Action Required. 7) Click in the Resolution Comment box. 8) Type the following comment “Patient weight is not exclusionary for this

protocol. Patient was accepted into study.” 9) Click OK.

The field has now turned Green to indicate that the discrepancy has been closed.



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Exercise C3: Creating a Manual Field/Section Discrepancy Task 1: Creating a Manual Discrepancy on a Data Field

1) Click in the Time field on the VITALS page. 2) Click on the Add Discrepancy button.

3) Leave the default reason of Data Entry comment in the Reason drop-down box.

4) Click in the Description field. 5) Type the following comment “Per the source document, the time of vitals was

recorded as 11:00. Please clarify and correct if appropriate.” 6) Click in the Action drop-down box. 7) Select Send to Investigator. 8) Click OK. 9) Click the Save icon. 10) Click OK. 11) Click the red X in the top right hand corner of the screen.


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Task 2: Adding a Section discrepancy You will create a Section discrepancy for this entire eCRF to alert the site user to revisit this eCRF to correct the data. To do so, you must first click in any field within the section to which you want to create the discrepancy.

1) Open the Demography page. 2) Click in the Subject Initials field. 3) Click on the Add Discrepancy button. 4) Select the radio button Section Discrepancy.

Leave the default reason of Data Entry comment in the Reason drop-down box.

5) Click in the Description field. 6) Type the following comment “Per the source document, demographic

information appears to be incorrect. Please clarify and correct to reflect source data documentation.”

7) Click in the Action drop-down box. 8) Select Send to Investigator. 9) Click OK.

The section is now highlighted in yellow to reflect that an open discrepancy exists on that section that is actionable by another user group, i.e. the site.

10) Click Save. 11) Click OK. 12) Click the red X in the top right hand corner of the screen.


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Exercise C4: Verification of patient data Task 1: Verifying CRF page

1) Click the Inclusion page icon. 2) Click the Verify icon.

3) Click Verify. 4) Click the NEXT CRF option in the top right hand corner of the screen. 5) Click the Verify icon. 6) Click Verify.

You have successfully verified the first two pages of the patient case book. Task 2: Unverifying a CRF page Imagine that you had verified the Exclusion criteria page in error and wished to unverify it.

1) Click the Verify icon. 2) Click Undo Verification. 3) Click the red X in the top right hand corner of the screen. 4) Click the Refresh button to update the Casebook Spreadsheet view.


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If data, investigator comments or discrepancies are modified (changed, added, deleted) after the eCRF has been verified, the eCRF may require re-verification. If so, a red arrow displays next to the verified icon. This indicates that you need to re-verify the eCRF due to updated information on the case report form.

You would need to use the Verify icon to re-verify the page.


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Exercise C5: Viewing an Investigator comment

1) Open the Vitals page. 2) In the Highlight box, select Investigator comment.

The fields that have Investigator comments display in purple.

3) Open the CRF Navigator pane. 4) Select the Investigator comment tab on the right hand side. 5) Click on “Systolic blood pressure in mmHg” in the list section. 6) View comment in the Details section below. 7) Click the red X in the top right hand corner of the screen.

Exercise C6: Logging Out



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Exercise I1: Logging in, Navigation and Patient Selection

• Navigate to the assigned website provided by your trainer. • Login using the Investigator credentials provided by your trainer. Exercise I2: Electronic Approval of patient data

1) Navigate to the Patient Search area. 2) Use the + sign to expand the Patient Search section. 3) Enter your assigned subject number in the first Range field and click Go. 4) Place a checkmark in the box to the left of your assigned patient number. 5) Click Go.

From the Casebook Spreadsheet you have access to the Approval functionality via the Select Patients and…drop down list.

6) Place a checkmark in the box to the left of your assigned patient number 7) Click the Select Patients and …drop-down list. 8) Choose Approve.

9) Click Go. 10) Enter your OC RDC username and password. 11) Leave default settings. 12) Click Continue. 13) Click Yes. 14) Click Close. 15) Click the Refresh button to update the Casebook Spreadsheet view. 16) Click the VISIT drop-down list. 17) Select the VISIT 1 visit.

A small signature appears at the bottom of the Inclusion eCRF icon indicating approval of the eCRF page.



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Exercise I3: Logging Out


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Oracle Clinical Remote Data Capture 4.5.3 HTML (OC RDC) Oracle Clinicalstorage.ppdi.com/edc/html/reference/cra/4.5.3_Project_Team... · (OC RDC) OC RDC 4.5.3 Project Team Training