main changes in rdc onsite for oracle

Main changes in RDC Onsite

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MAIN CHANGES IN RDC ONSITE FOR ORACLE

VERSION VERSION DATE DOCUMENT DETAILS AUTHOR1.0 23-JUN-2015 First version G. Pimentel


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ContentsSTUDY AND SITE/CENTER SELECTION ................................................................................................................4

PATIENT SELECTION ...........................................................................................................................................5

RECORDING DATA ..............................................................................................................................................8

CHANGING/CORRECTING DATA .........................................................................................................................9

CRF VERIFICATION TOOL ..................................................................................................................................10

INVESTIGATOR APPROVAL TOOL .....................................................................................................................12


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IMPORTANT:

BEFORE BEGINNING TO WORK WITH RDC ONSITE, COMPATIBILITY VIEW MUST BEDISACTIVATED.

LOGOUT SCREEN

After leaving RDC Onsite, it is possible to enter again without needing to reload the page:


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STUDY AND SITE/CENTER SELECTIONThe drop-down menus to select a study (in the case where you have access to multiple studies) and itscorresponding site are found on the left side of the home screen. One the ‘Study’ and the ‘Site’ are selectedthey will load automatically:

Left-clicking on the image for a patient makes a window appear with a summary of the informationcollected in RDC Onsite:

This summary information is also available in the ‘Patient Casebooks’ window:


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PATIENT SELECTIONAll the patients for the selected site can be found in the ‘Home’ page. Using the cursor we can select thecharacteristics of the patient that we want to review (if you want to review more than one, you must usethe Ctrl key to select it). Using the ‘Patient Search’ option, you can filter using multiple options in order toreduce the number of patients displayed in the ‘Home’ page:

After filtering the patients which you want to work with, select them by left-clicking the patient icon. Toselect more than one, while pressing the ‘Control’ key, click on the patients you want to select (1). Next click‘Action’ and select the action that you want to perform (2):

1-Select the patients.

2-Select the action.


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Depending on the action that you select, the ‘Patient Casebooks’ page will show different information:

Actions:-Multi-Patient View: shows the patients’ data by visit. To see the data from another visit you must

select from the ‘Visit’ drop-down menu:

-Single-Patient View: shows us the data for all of the patient’s visits on the same page. To change

patient we use the or onscreen arrows.

If the PatientCasebook windowis too small to beseen properly, closethe PatientSummary windowby clicking on thearrow.


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-Review Discrepancies: shows a list of the pages which contain a discrepancy.

-Review CRFs: shows a list with all the completed pages in a patient’s eCRF.

From the ‘Patient Casebook’ window and with the ‘Single Patient View’, you may use the ‘Filter’ toselect/search for various CRF statuses for a patient.


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RECORDING DATA

The CRF pages are ONLY saved once, removing the ‘Save incomplete’ option. When a page is saved, anyterms which require it are coded and the data checks are performed, generating the consequentdiscrepancies.

When returning to the page to record New data, the system will not demand a reason unless the existingdata on the page is changed or removed.

After saving a page using the disk icon the saved page will NOT close automatically; it is necessary touse the Windows/Safari browser to access it and to close it, otherwise it will remain open.

If we advance or go back a page using the options, the saved page closesbut the page we are accessing remains open behind the main browser; it is necessary to use theWindows/Safari browser to access it.Before passing to the next page, the system will ask what we would like to do with the new data.Depending on the version of Internet Explorer used, the window which opens may not be fully displayed;

meaning that we need to move to the right with the scroll bar to see the ‘Save’ option:


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CHANGING/CORRECTING DATA

Upon changing/correcting data on a page, the ‘Audit history’ will now show the date/time and author ofthe original data introduced (1) and the same information for the change made (2).

1 original2 change2 change


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CRF VERIFICATION TOOL

To verify the CRFs, you must select the patient(s) in the ‘Home’ window and, having displayed the ‘Patient

Casebooks’, the ‘Verify’ option will become available.

IMPORTANT: depending on the type of view selected in the ‘Patient Casebooks’, the verification will applyto ALL THE PATIENT’S PAGES or only to the pages for the selected visits.

If the view is ‘Multiple’, ALL of the pages and visits for the selected patient(s) are included although you canonly see the selected visit(s) on screen.

To only verify the pages for one visit, you must filter using the ‘Single’ view and select the visit that youwant to verify.

Only 2 CRFs appear on screen, but in the Multipleview, ALL the selected patients’ pages areselected: 6 CRFs

For the patient X1 on screen, thebaseline visit has been selectedwhich only has 3 CRFs.


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To only verify one page for a patient, you must open the page and verify it using from the upper toolbar.

From the ‘Patient Casebooks’ window and the ‘Multiple’ view, a variety of filters can be applied by type ofCRF, visit, page name, etc if you want to (for example) verify a specific page for a specific visit for all of thepatients in the selected site.


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INVESTIGATOR APPROVAL TOOL

To approve the CRFs, you must select the patient(s) on the ‘Home’ screen and upon opening the ‘Patient

Casebooks’ window the ‘Approve’ option will become available.

IMPORTANT: depending on the type of view selected in the ‘Patient Casebooks’, the approval will apply toALL THE PATIENT’S PAGES or only to the pages for the selected visits.

If it is a ‘Multiple’ view, ALL of the pages and visits for the selected patient(s) are included although you canonly see the selected visit(s) on screen.

To only approve the pages for one visit, you must filter using the ‘Single’ view and select the visit that youwant to approve.

Only 2 CRFs appear on screen, but in theMultiple view, ALL the selected patients’pages are selected. 3 CRFs


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To only approve one page for a patient, you must open the page and approve it using from the uppertool bar.

From the ‘Patient Casebooks’ window and the ‘Multiple’ view, a variety of filters can be applied by type ofCRF, visit, page name, etc if you want to (for example) approve a specific page for a specific visit for all ofthe patients in the selected site.

main changes in rdc onsite for oracle

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