quick user guide to the clear clinica cloud edc system
TRANSCRIPT
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Rev. 1.6 Sep 2015 www.clearclinica.com
eCRF Guide and Guidelines for using Clear Clinica Cloud EDC
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Part I - Introduction
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Learning objectives
• What is Clear Clinica Cloud EDC?• Understand concepts• Use basic functions• Use Subject matrix• Use miscellaneous functions – help, print CRF
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What is Clear Clinica Cloud EDC?
• Clear Clinica Cloud EDC is an online Web service.– Full EDC system based on ClinCapture – the leading
Open Source EDC system– Accessible with any major browser: Firefox, Chrome,
Internet Explorer• Mac, Windows, Linux
– Full set of functions for eCRF, query and discrepancy management, data extracts and reports
– Fully integrated with Clear Clinica central monitoring. See http://www.clearclinica.com/
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(1) Basic concepts• Study – a clinical trial or research study.• Site – hospital or clinic• Study event – a visit of a study subject at a site during a study. A study
event contains 1 or more eCRFs• eCRF – electronic case report form. • Subject case book – a complete set of study events for a given subject• Item – a question on an eCRF• Discrepancy note – a query or comment relating to the item data
– Validation queries are automatically generated by eCRF pre-programmed edit checks.
– Discrepancy notes are manually entered by a study monitor or CRC/PI as required.
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(2) New subject 1-2-3
1. Add Subject: Enter Subject ID, Date of enrollment, click Save and Finish
2. Baseline Evaluation: In the popup, click Proceed to enter data
3. Enter data in CRF: Click on Pencil icon, enter data, mark CRF complete and Save
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User interface (UI)
• Web application that runs in your browser– All modern browsers including Chrome and on Windows– Windows, Linux and Mac
• Basic UI after login– Top level status info with Change site/Study link– To navigation bar– Left side bar– Body– Plus(+)/minus(-) signs to expand/contract content– Navigation buttons – Submit, Back etc…
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(3) UI Navigation
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Training users
• We will demonstrate user functions with a CRC, surf to: https://uat1.clearclinica.com/<your study>
• User/Password: Ask your Data Manager
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(4) Roles – who can do what?
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Data Manager Role• Can be limited to “user” privileges– Cannot Add Subject or Delete data– Can edit existing data– Monitor and manage data
• SDV• Study Audit Log• Edit and create new edit checks (Rules Studio)• Evaluate CRF• Create dynamic groups of subjects
– Extract data– Study Setup– No privileges to add users, sites, studies
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Data Manager Role
• Can have “administrator” privileges• All of the above +• Can remove a Subject or Event forever
– For example a patient was entered twice into the database under 2 different Subject IDs
• Privileges to add users, sites, studies
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(6) Subject matrix
• Click on Subject Matrix in top tool bar https://uat1.clearclinica.com/<your study>/ListStudySubjects
• Hover over a subject– When data: Shows events– When no data: Schedule events/enter data
• Left tool bar– Icon legend (Colored icons) – Actions (green icons)
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Subject matrix
• Shows all subjects and their study events (visits) horizontally:
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Navigation• On the left – you will see a Help button and a bunch of icons:• Icon Legend - Event/ECRF status• Actions - View/Edit
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(7) View Subject
• To view detailed information about a subject, select the View icon on the right hand side of the matrix under Actions:– View Subject Record with magnifier– Flags to add discrepancy notes
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(8) View event
• When you click on View/Enter Data for an event, the list of eCRFs associated with that event are listed.
• (You can get to this screen either by clicking on View icon from the View Subject screen, or by clicking on the event in the Subject Matrix then choosing “View / Enter Data”.)
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(9) View/Edit eCRF
• When you click on Edit you are brought to the data entry page for the selected CRF.
• The page shows the subject study number at the top right, and the CRF name with the status icon of the CRF next to it.
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(10)Add subject
• Site CRC and PI roles can add subjects.• Study roles cannot add new subjects• Click on
https://uat1.clearclinica.com/<your study>/AddNewSubject
• After adding subject you start entering data for events like in New Subject 1-2-3
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(11) User profile
• Top line always shows User Name and Role – Currently logged-in user and role (for example
Site A – Clinical research coordinator)• Click on this link at any time to access and
change your User Profile – including changing your password.– Also from ‘User Profile’ in the Tasks menu
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Logout
• Logout – use the logout button• Don’t just close the browser– This will leave open sessions on the server and
potentially cause problems
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Miscellaneous functions
• Print a CRF– When viewing a subject, or event, you have a print
icon.• A window pops up with the subject CRF and data• You may need to play with the print definitions
(landscape or portrait or paper size to get it right)
• Online help– Click on the help link…
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Part II – Entering Data
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Learning Objectives
• Understand data entry controls• Enter, save, edit data• Missing data• Enter Discrepancy notes• Mark CRF complete• View Audit history
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Scheduling events
• Events can be scheduled before data entry• Scheduling an event simply means entering
the (planned) start date of that event for that subject. You can schedule a number of events at once, or just schedule them when you wish to start data entry for the eCRFs.
• Or – you can start entering data
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Navigation• On the left – you will see a Help button and a bunch of icons:• Icon Legend - Event/ECRF status• Actions - View/Edit
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(12)Data entry from subject matrix
• Hovering over an event in the Subject matrix “pops up” a box with buttons for data entry and event update.
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How to enter data
• Click on a CRF form in the event pop-up box:– Click on the pencil icon to enter data– Click on the magnifier icon to view data
• When you start entering data into the form, the icon changes color and the event status is changed to Data entry started
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Update Study Event status• Hover over an event. Click on Pencil icon.• Before data entry, you can update status. – Scheduled, Data entry started, Stopped, Skipped
• After data entry starts, you can update status:– Data entry started, Stopped
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(13)Data entry controls• Date fields• Text boxes• Select lists• Edit checks• Show/hide dynamic items
– CRF items may be initially hidden and then displayed when you enter a value of a parent item
• Items can optional or required– If a field is required, you cannot Save the CRF without entering a value.– If data fails the edit check, a red warning is produced, a query is
generated and the user may save the CRF with a query (Discrepancy Note), and come back later and fix the data.
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Edit checks
• Fairly complex edit checks can be programmed for an item– Numerical ranges– Calculations, ranges. . .– Logical conditions inside the CRF– Logical conditions between CRFs
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(14)Mark CRF complete
• Click the check box on a single event– Submit changes
• Or mark all CRFs as complete from the subject matrix
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(15)Missing data
• If you are missing a required field a red error message will appear at the top of the form.
• Click the query flag next to the item that will be outlined in red and create a discrepancy note
• Save the form – you will be prompted
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(16)Discrepancy notes• ClinCapture uses Discrepancy Notes flag icons to record
information about item values (e.g. Comments),and to record and track Queries– Blue – no discrepancy note exists; authorized users can click the
flag to add one if required– Black – closed– Red – new– Green – resolution proposed; e.g. a site user has answered a
query raised by a sponsor user, and is suggesting the query be closed
– Amber – updated; e.g. some more information has been added to the note thread
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(17) CRA - work flow
• Study Monitor role flags a discrepancy• Assigns to a CRC or PI:– Discrepancy note status changes to Update– PI logs in and can view his Updated notes, take action and
annotate what he/she did– Discrepancy & Notes in the top tool bar shows a list of
notes from oldest to newest.
• After the note is updated by CRC or PI, it is returned to the Study Monitor – for closing.
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(18) CRA - Patients with SDV checked
• Click Tasks>Source Data verification– Click in the box under SDV Status and select not
done
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(19) CRA - eCRF data entry complete
• Click Tasks>Create a data set – Select CRFs with data entry complete option– Select whatever fields you want to see
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(20)Changing data
• Administrative edit or edit before marked Complete
• Click query flag and annotate reason for change in description, Submit and close.
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(21)Study Audit log
• Click study audit log in top navigation bar• Filtering by Study Subject ID – Shows complete audit trail of all new data entry
and changes and when they happened
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(22)Deleting data
• Remove– Soft delete. – Data stays in system– If CRF is not marked complete, you can delete it– Data manager CAN REMOVE
• Delete– Hard delete– All data associated with the CRF in Event is removed– Only Administrator role CAN DELETE!
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(23)Signatures
• Only the PI role can sign• Click on the Green Sign action icon on far right
in Subject matrix.
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Thank you!
• Thanks for taking the time to sit through yet another PowerPoint presentation.
• We hope this helps you get started with Clear Clinica Cloud EDC