Rev. 1.6 Sep 2015 www.clearclinica.com

eCRF Guide and Guidelines for using Clear Clinica Cloud EDC

Part I - Introduction

Learning objectives

• What is Clear Clinica Cloud EDC?• Understand concepts• Use basic functions• Use Subject matrix• Use miscellaneous functions – help, print CRF

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/

(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.

(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

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…

(3) UI Navigation

Training users

• We will demonstrate user functions with a CRC, surf to: https://uat1.clearclinica.com/<your study>

• User/Password: Ask your Data Manager

(4) Roles – who can do what?

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

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

(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)

Subject matrix

• Shows all subjects and their study events (visits) horizontally:

Navigation• On the left – you will see a Help button and a bunch of icons:• Icon Legend - Event/ECRF status• Actions - View/Edit

(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

(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”.)

(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.

(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

(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

Logout

• Logout – use the logout button• Don’t just close the browser– This will leave open sessions on the server and

potentially cause problems

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…

Part II – Entering Data

Learning Objectives

• Understand data entry controls• Enter, save, edit data• Missing data• Enter Discrepancy notes• Mark CRF complete• View Audit history

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

Navigation• On the left – you will see a Help button and a bunch of icons:• Icon Legend - Event/ECRF status• Actions - View/Edit

(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.

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

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

(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.

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

(14)Mark CRF complete

• Click the check box on a single event– Submit changes

• Or mark all CRFs as complete from the subject matrix

(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

(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

(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.

(18) CRA - Patients with SDV checked

• Click Tasks>Source Data verification– Click in the box under SDV Status and select not

done

(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

(20)Changing data

• Administrative edit or edit before marked Complete

• Click query flag and annotate reason for change in description, Submit and close.

(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

(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!

(23)Signatures

• Only the PI role can sign• Click on the Green Sign action icon on far right

in Subject matrix.

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