Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-

controlled prophylaxis study

Data Management Overview v2.0, 6th July 2020

2V2.0, 06 July 2020

Trial Data Overview

3V2.0, 06 July 2020

Site Staff Access to AxiomCOPCOV – Study Coordinator (Research Nurse) Training Workflow

1. Fusion Video Training

Trials Unit will provide Fusion Video Training Link to Site Personnel –

User will send their details of video completion to Axiom Customer Care at the end of the Video by completing Registration -

Registration:

Please click , enter your contact details, and click the Submit Details button.

2. Fusion User Registration

Once Step 1 is completed, our Customer Care Team will send an email with Fusion User Registration Details including the Study URL, as well as Training Certificate

3. Fusion User Activation

Axiom Customer Care to activate Users once Fusion Video Training has been completed, Fusion User Registration has been completed and Trials Unit has confirmed Site Assignment

4. Principal/Sub-Investigator Additional Video Upon first login Investigators will need to watch an additional ~10 minute video before they can enter data

4V2.0, 06 July 2020

• Expressions of Interest downloaded by the Trials Unit into an Excel spreadsheet

• Secure transfer to site via Trials Unit eRoom

• Access provided to site staff identified as responsible for downloading spreadsheet (minimum 2 per site for cross cover)

• Staff requiring access will be sent individual User Request Form for completion and return to Trials Unit (via a secure server)

• Login details will be sent to users via email

• Automatic email notification sent to users when file is uploaded by Trials Unit

• Login, download and save spreadsheet to Trust network

• Frequency of transfer will depend upon rate of completion

Site Staff Access to Recruitment Data

5V2.0, 06 July 2020

• Participant Card given upon enrolment

• Provides participant with:• Instructions on:

• Logging in to the Axiom Fusion website where they will enter Baseline/Visit 1 data etc.

• Downloading and logging in to the Axiom ePro Smartphone app where they will enter daily symptom check data

• Study team contact details

• Follow up visit dates

• COPCOV Study Subject eDiary User Guide

• Confirm WiFi available in clinic area for participant to download app

Participant Data Collection – Axiom ePRO

6V2.0, 06 July 2020

Participants will use this phone app to enter daily symptom check data

Participant Data Collection – Axiom ePRO (cont.)

7V2.0, 06 July 2020

• Participants will receive a notification on their phone each day as a reminder

• AND when a FU visit is due

Participant Data Collection – Axiom ePRO (cont.)

8V2.0, 06 July 2020

• Participants will use this website to enter baseline/visit 1, FU and some other data

• It works better on a PC, laptop or tablet/iPad

• Possible on a phone but awkward

Participant Data Collection – Axiom Fusion

9V2.0, 06 July 2020

Participant Data Collection – Axiom Fusion1. Select the form to complete from those available on the left e.g. baseline

2. The form will open for you to enter the data

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Participant Data Collection – Axiom Fusion

Add other forms as required e.g. concomitant medication

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Staff Data Collection – Axiom Fusion

Log in.

The Home screen will display

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Staff Data Collection – Axiom Fusion

Select the “Manage Subjects” tab to see a list of the participants at your site.

Add a new participant by selecting “add subject” from the Page actions on the left.

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Staff Data Collection – Axiom Fusion

• For site staff to complete a participant facing eCRF• Select the page action button

• This will unlock the page and allow entry of the visit details.

• If the post day 90 follow-up visit is not required, indicate as “Not

Applicable”

• Once data entry is complete on any form, mark the form as SDR to

enable review by monitors/data managers

• Select the page action button

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Site Data Management

• Monitor participant status (well/unwell from dashboard)• Monitor daily ePRO data entry by participant• Ensure completeness of Axiom Fusion data if entered by participant • Reports available to assist with this process

• Subject e-diary data listing• Unwell subjects report

• Emergency paper CRFs are available if you cannot access Axiom

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Select the “Subject eDiary” tab

View eDiary Overview Screen in Fusion

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Click on column title to sort

View eDiary Overview Screen in Fusion

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1. Access the available reports within Fusion by selecting the “ Reports” tab, and clicking on the title

2. Select the site from the Page actions then click on “submit”

3. The report is available from your “downloads” folder

eDiary Data Listing

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1. Access the available reports within Fusion by selecting the “ Reports” tab, and clicking on the title

2. Select the site from the Page actions then click on “submit”

3. The report will display in your screen. If desired you can export as Excel or PDF.

Unwell Subjects Report

19V2.0, 06 July 2020

Central Data Management

• Data will be reviewed and queries raised within the Axiom Fusion system by the central Data Management team• Queries should be responded to within 5 working days• To correct entries within Axiom, amend the data• A prompt box will appear for you to record the reason for change

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Additional InformationReference Documents:• COPCOV UK CRF Completion Guidelines• COPCOV UK CRF Binder• User guides within Fusion

• e.g. Tips and Tools - ePRO Portal and Eligibility Review Tips and Tools

• COPCOV Study Subject eDiary User Guide

Always refer to https://www.copcov.org/sites.html for correct version of documents

If you have any further questions please contact copcov@dtu.ox.ac.uk

V2.0, 06 July 2020